[Federal Register Volume 87, Number 209 (Monday, October 31, 2022)]
[Proposed Rules]
[Pages 65548-65567]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-23376]



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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2022-0462; FRL-10183-02-OCSPP]
RIN 2070-AB27


Significant New Use Rules on Certain Chemical Substances (22-
2.5e)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing significant new use rules (SNURs) under the 
Toxic Substances Control Act (TSCA) for chemical substances that were 
the subject of premanufacture notices (PMNs) and are also subject to 
Orders issued by EPA pursuant to TSCA. The SNURs require persons who 
intend to manufacture (defined by statute to include import) or process 
any of these chemical substances for an activity that is proposed as a 
significant new use by this rule to notify EPA at least 90 days before 
commencing that activity. The required notification initiates EPA's 
evaluation of the use, under the conditions of use for that chemical 
substance, within the applicable review period. Persons may not 
commence manufacture or processing for the significant new use until 
EPA has conducted a review of the notice, made an appropriate 
determination on the notice, and has taken such actions as are required 
by that determination.

DATES: Comments must be received on or before November 30, 2022.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2022-0462, through the Federal eRulemaking 
Portal at https://www.regulations.gov. Follow the online instructions 
for submitting comments. Do not submit electronically any information 
you consider to be Confidential Business Information (CBI) or other 
information whose disclosure is restricted by statute. Additional 
instructions on commenting and visiting the docket, along with more 
information about dockets generally, is available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: 
    For technical information contact: 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 contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you manufacture, 
process, or use the chemical substances contained in this proposed 
rule. The following list of North American Industrial Classification 
System (NAICS) codes is not intended to be exhaustive, but rather 
provides a guide to help readers determine whether this document 
applies to them. Potentially affected entities may include:
     Manufacturers or processors of one or more subject 
chemical substances (NAICS codes 325 and 324110), e.g., chemical 
manufacturing and petroleum refineries.
    This action may also affect certain entities through pre-existing 
import certification and export notification rules under TSCA. Chemical 
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import 
provisions promulgated at 19 CFR 12.118 through 12.127 and 19 CFR 
127.28. Chemical importers must certify that the shipment of the 
chemical substance complies with all applicable rules and Orders under 
TSCA, which would include the SNUR requirements should these proposed 
rules be finalized. The EPA policy in support of import certification 
appears at 40 CFR part 707, subpart B. In addition, pursuant to 40 CFR 
721.20, any persons who export or intend to export a chemical substance 
that is the subject of this proposed rule on or after November 30, 2022 
are subject to the export notification provisions of TSCA section 12(b) 
(15 U.S.C. 2611(b)) (see 40 CFR 721.20), and must comply with the 
export notification requirements in 40 CFR part 707, subpart D.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov or email. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as 
CBI and then identify electronically within the disk or CD-ROM the 
specific information that is claimed as CBI. In addition to one 
complete version of the comment that includes information claimed as 
CBI, a copy of the comment that does not contain the information 
claimed as CBI must be submitted for inclusion in the public docket. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting 
your comments, see the commenting tips at https://www.epa.gov/dockets/commenting-epa-dockets.

II. Background

A. What action is the Agency taking?

    EPA is proposing these SNURs under TSCA section 5(a)(2) (15 U.S.C. 
2604(a)(2)) for certain chemical substances that were the subject of 
PMNs. These proposed SNURs would require persons to notify EPA at least 
90 days before commencing the manufacture or processing of any of these 
chemical substances for an activity proposed as a significant new use. 
Receipt of such notices would allow EPA to assess risks and, if 
appropriate, to regulate the significant new use before it may occur.
    The docket for these proposed SNURs, identified as docket ID number 
EPA-HQ-OPPT-2022-0462, includes information considered by the Agency in 
developing these proposed SNURs.

B. 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 four TSCA section 5(a)(2) factors 
listed in Unit III.

C. Applicability of General Provisions

    General provisions for SNURs appear in 40 CFR part 721, subpart A. 
These provisions describe persons subject to the rule, recordkeeping 
requirements, exemptions to reporting requirements, and applicability 
of the rule to uses occurring before the effective date of the rule. 
Provisions relating to user fees appear at 40 CFR part 700. Pursuant to 
40 CFR 721.1(c), persons subject to these SNURs must comply with the 
same significant new use notice (SNUN) requirements and EPA regulatory 
procedures as submitters of PMNs under TSCA section 5(a)(1)(A). These

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requirements include the information submission requirements of TSCA 
sections 5(b) and 5(d)(1), the exemptions authorized by TSCA sections 
5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 
720. Once EPA receives a SNUN and before the manufacture or processing 
for the significant new use can commence, EPA must either determine 
that the use is not likely to present an unreasonable risk of injury 
under the conditions of use for the chemical substance or take such 
regulatory action as is associated with an alternative determination. 
If EPA determines that the use is not likely to present an unreasonable 
risk, EPA is required under TSCA section 5(g) to make public, and 
submit for publication in the Federal Register, a statement of EPA's 
findings.

III. Significant New Use Determination

    TSCA section 5(a)(2) states that EPA's determination that a use of 
a chemical substance is a significant new use must be made after 
consideration of all relevant factors, including:
     The projected volume of manufacturing and processing of a 
chemical substance.
     The extent to which a use changes the type or form of 
exposure of human beings or the environment to a chemical substance.
     The extent to which a use increases the magnitude and 
duration of exposure of human beings or the environment to a chemical 
substance.
     The reasonably anticipated manner and methods of 
manufacturing, processing, distribution in commerce, and disposal of a 
chemical substance.
    In determining what would constitute a significant new use for the 
chemical substances that are the subject of these SNURs, EPA considered 
relevant information about the toxicity of the chemical substances, 
potential human exposures and environmental releases that may be 
associated with possible uses of these chemical substances, in the 
context of the four TSCA section 5(a)(2) factors listed in this unit.
    The proposed rules include PMN substances that are subject to 
Orders issued under TSCA section 5(e)(1)(A), as required by the 
determinations made under TSCA section 5(a)(3)(B). The TSCA Orders 
require protective measures to limit exposures or otherwise mitigate 
the potential unreasonable risk. The proposed SNURs identify 
significant new uses as 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).
    Where EPA determined that the PMN substance may present an 
unreasonable risk of injury to human health via inhalation exposure, 
the underlying TSCA Order usually requires that potentially exposed 
employees wear specified respirators unless actual measurements of the 
workplace air show that air-borne concentrations of the PMN substance 
are below a New Chemical Exposure Limit (NCEL), and includes 
requirements addressing performance criteria for sampling and 
analytical methods, periodic monitoring, respiratory protection, and 
recordkeeping. No comparable NCEL provisions currently exist in 40 CFR 
part 721, subpart B, for SNURs. Therefore, for these cases, the 
individual SNURs in 40 CFR part 721, subpart E, will state that persons 
subject to the SNUR who wish to pursue NCELs as an alternative to the 
40 CFR 721.63 respirator requirements may request to do so under 40 CFR 
721.30. EPA expects that persons whose 40 CFR 721.30 requests to use 
the NCELs approach for SNURs that are approved by EPA will be required 
to comply with NCELs provisions that are comparable to those contained 
in the corresponding TSCA Order for the same chemical substance.

IV. Rationale and Objectives of the Proposed Rule

A. Rationale

    During review of the PMNs submitted for the chemical substances 
that are the subject to these proposed SNURs, EPA concluded that 
regulation was warranted under TSCA section 5(e), pending the 
development of information sufficient to make reasoned evaluations of 
the health or environmental effects of the chemical substances. The 
basis for such findings is outlined in Unit V. Based on these findings, 
TSCA section 5(e) Orders requiring the use of appropriate exposure 
controls were negotiated with the PMN submitters. As a general matter, 
EPA believes it is necessary to follow the TSCA Orders with a SNUR that 
identifies the absence of those protective measures as significant new 
uses to ensure that all manufacturers and processors--not just the 
original submitter--are held to the same standard.

B. Objectives

    EPA is proposing these SNURs for specific chemical substances which 
have undergone premanufacture review because the Agency wants:
     To identify as significant new uses any manufacturing, 
processing, use, distribution in commerce, or disposal that does not 
conform to the restrictions imposed by the underlying TSCA Orders, 
consistent with TSCA section 5(f)(4).
     To have an opportunity to review and evaluate data 
submitted in a SNUN before the notice submitter begins manufacturing or 
processing a listed chemical substance for the described significant 
new use.
     To be able to either determine that the prospective 
manufacture or processing is not likely to present an unreasonable 
risk, or to take necessary regulatory action associated with any other 
determination before the described significant new use of the chemical 
substance occurs.

V. Substances Subject to This Proposed Rule

    EPA is proposing significant new use and recordkeeping requirements 
for certain chemical substances in 40 CFR part 721, subpart E. In this 
unit, EPA provides the following information for each chemical 
substance that is identified in this unit as subject to this proposed 
rule:
     PMN number (the proposed CFR citation assigned in the 
regulatory text section of the proposed rule).
     Chemical name (generic name, if the specific name is 
claimed as CBI).
     Chemical Abstracts Service (CAS) Registry number (if 
assigned for non-confidential chemical identities).
     Effective date of and basis for the TSCA Section 5(e) 
Order.
     Potentially Useful Information.
    The chemicals subject to these proposed SNURs are as follows:

PMN Number: P-16-349 (40 CFR 721.11752)

    Chemical Name: Quaternary ammonium salt of polyisobutene succinic 
acid (generic).
    CAS Number: Not available.
    Effective date of modification of TSCA Order: October 18, 2021.
    Basis for TSCA Order modification: The PMN states that the generic 
(non-confidential) use of the substance will be as a fuel additive. On 
November 30, 2018, EPA issued a Consent Order regarding premanufacture 
notice P-16-349. The Order was issued under TSCA sections 5(a)(3)(B)(i) 
and 5(e)(I)(A)(i), based on a finding that the available information is 
insufficient to permit a reasoned evaluation of the environmental 
effects of the PMN substance. The order required the Company to submit 
to EPA certain toxicity testing before any manufacturing, processing, 
or use of the PMN substance to address potential

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environmental risks. The Order was also issued under TSCA sections 
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the 
absence of sufficient information to permit a reasoned evaluation, the 
substance may present an unreasonable risk of injury to human health 
and the environment. Additionally, the Order was issued under TSCA 
sections 5(a)(3)(B)(ii)(II) and 5(e)(1)(A)(ii)(II), based on a finding 
that the substance is or will be produced in substantial quantities and 
that the substance either enters or may reasonably be anticipated to 
enter the environment in substantial quantities, or there is or may be 
significant (or substantial) human exposure to the substance.
    On January 20, 2020, the Company submitted to EPA the following 
testing in accordance with the requirements of the Consent Order: an 
inherent biodegradability study/Zahn-Wellens/EMPA test based on OECD 
Test Guideline 302B; a freshwater acute fish toxicity study; a marine 
acute fish toxicity study; an acute aquatic invertebrate toxicity; and 
an algal toxicity test. The Company also provided a report indicating 
that the fish acute toxicity mitigated by humic acid test was not 
conducted as no toxic effects were observed in the fish acute toxicity 
test. The required ecotoxicity and fate tests were reviewed and found 
to be acceptable. The results of these tests demonstrated that the 
substance has low environmental hazard.
    On October 18, 2021, EPA issued a modified Consent Order to allow 
manufacturing, processing, and use of the PMN substance under certain 
limitations. Based on comparison to analogous chemical substances, EPA 
has identified concerns for developmental toxicity. Based on the 
surfactant properties of the PMN substance, EPA has also identified 
concerns for lung effects. To protect against these human health risks, 
the consent Order modification requires:
     Use of personal protective equipment where there is a 
potential for dermal exposure;
     Establishment of a hazard communication program, including 
human health precautionary statements on each label and in the SDS;
     No use of the PMN substance in any consumer product to be 
added to gasoline or diesel fuels by the consumer;
     Use of the PMN substance only for the confidential use 
allowed in the Order; and
     No manufacture, processing, or use of the PMN substance in 
any manner that results in inhalation exposure.
    The proposed SNUR designates as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that would be 
designated by this SNUR. EPA has determined that information that would 
inform the understanding of absorption and developmental effects would 
be potentially useful to characterize the human health effects of the 
PMN substance. Although the Order does not require the development of 
this information, the Order's restrictions remain in effect until the 
Order is modified or revoked by EPA based on submission of this or 
other relevant information.

PMN Number: P-18-27 (40 CFR 721.11753)

    Chemical Name: 2-Propenoic acid, 2-alkyl-, 2-(dialkylamino)alkyl 
ester, polymer with alpha-(2-alkyl-1-oxo-2-alken-1-yl)-omega-
methoxypoly(oxy-1,2-alkanediyl) (generic).
    CAS Number: Not available.
    Effective Date of TSCA Order: December 1, 2021.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the substance will be as an additive in coatings. 
Based on structural alerts for aliphatic amines and polyamines, 
information provided in the SDS, and comparison to analogous 
substances, EPA has identified concerns for irritation to the skin, 
eyes, and respiratory tract, lung effects, and skin sensitization. The 
Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient 
information to permit a reasoned evaluation, the substance may present 
an unreasonable risk of injury to human health or the environment. To 
protect against these risks, the Order requires:
     Use of personal protective equipment where there is a 
potential for dermal exposure;
     Use of a NIOSH-certified particulate respirator with an 
APF of at least 50, or of at least 1,000 when spray applied, where 
there is a potential for inhalation exposure;
     No use of the PMN substance in formulations greater than 
0.1% for spray applications; and
     Establishment of a hazard communication program, including 
human health precautionary statements on each label and in the SDS.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of 
specific target organ toxicity, pulmonary effects, eye irritation, skin 
irritation, and skin sensitization testing may be potentially useful to 
characterize the health effects of the PMN substance. Although the 
Order does not require these tests, the Order's restrictions remain in 
effect until the Order is modified or revoked by EPA based on 
submission of this or other relevant information.

PMN Number: P-18-301 (40 CFR 721.11754)

    Chemical Name: Alkanedioic acid, polymer with cycloalkyl 
dimethanol, alkyl and cycloalkyl diisocyanates, dimethyl-alkanediol, 
dihydroxyalkanoic acid methylenebis[isocyanatocyclohexane, hydroxyethyl 
acrylate- and polyalkyl glycol monoalkyl ether blocked (generic).
    CAS Number: Not available.
    Effective date of TSCA Order: June 22, 2021.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the substance will be as a coating component. 
Based on the TSCA New Chemical Program Chemical Category for acrylates, 
EPA identified irritation and sensitization hazards for the PMN 
substance. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) 
and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of 
sufficient information to permit a reasoned evaluation, the substance 
may present an unreasonable risk of injury to human health or the 
environment. To protect against these risks, the Order requires:
     Use of personal protective equipment where there is a 
potential for dermal exposure;
     Use of a NIOSH-certified respirator with an APF of at 
least 50 where there is a potential for inhalation exposure;
     Establishment of a hazard communication program, including 
human health precautionary statements on each label and in the SDS; and
     No use of the PMN substance in a consumer product.
    The proposed SNUR designates as a ``significant new use'' the 
absence of these protective measures.

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    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that would be 
designated by this SNUR. EPA has determined that information that would 
inform the understanding of skin irritation and sensitization would be 
potentially useful to characterize the human health effects of the PMN 
substance. Although the Order does not require the development of this 
information, the Order's restrictions remain in effect until the Order 
is modified or revoked by EPA based on submission of this or other 
relevant information.

PMN Number: P-18-340 (40 CFR 721.11755)

    Chemical Name: Poly(oxy-1,4-butanediyl), alpha-hydro-omega-hydroxy-
, polymer with 1,1'-methylenebis[4-isocyanatobenzene),caprolactam-
blocked.
    CAS Number: 2247074-17-3.
    Effective Date of TSCA Order: March 22, 2022.
    Basis for TSCA Order: The PMN states that the use of the substance 
will be for one component thermoset elastomer manufacture. Based on the 
structural alert for diisocyanates, EPA has identified concerns for 
skin and respiratory sensitization. Based on test data for the 
hydrolysis product caprolactam, EPA has also identified concerns for 
neurotoxicity, reproductive/developmental toxicity, respiratory tract 
effects, and systemic effects. The Order was issued under TSCA sections 
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the 
absence of sufficient information to permit a reasoned evaluation, the 
substance may present an unreasonable risk of injury to human health or 
the environment. To protect against these risks, the Order requires:
     Use of personal protective equipment where there is a 
potential for dermal exposure;
     Establishment of a hazard communication program, including 
human health precautionary statements on each label and in the SDS;
     No manufacture without the use of a packed tower scrubber 
that removes at least 95% of the PMN substance prior to release;
     No manufacturing, processing, or use of the PMN substance 
in any manner that results in inhalation exposure;
     No use of the PMN substance other than in one component 
thermoset elastomer manufacture; and
     No use of the PMN substance in a consumer product.
    The proposed SNUR designates as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that would be 
designated by this SNUR. EPA has determined that the results of skin 
sensitization, reproductive toxicity (developmental effects), pulmonary 
effects, neurotoxicity, and other specific target organ toxicity 
testing may be potentially useful to characterize the human health 
effects of the PMN substance. Although the Order does not require these 
tests, the Order's restrictions remain in effect until the Order is 
modified or revoked by EPA based on submission of this or other 
relevant information.

PMN Number: P-19-165 (40 CFR 721.11756)

    Chemical Name: Tall oil pitch, fraction, sterol-low (generic).
    CAS Number: Not available.
    Effective Date of TSCA Order: September 24, 2021.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) uses will be as a plasticizer in rubber and an additive 
for asphalt. EPA is unable to determine acute and chronic concentration 
of concern values for sediment-dwelling organisms and amphibians due to 
expected partitioning to sediments and a lack of scientific data to 
characterize the environmental hazards. The Order was issued under TSCA 
sections 5(a)(3)(B)(i) and 5(e)(1)(A)(i), based on a finding that the 
information available to the Agency is insufficient to permit a 
reasoned evaluation of the health and environmental effects of the new 
chemical substance. To protect against these risks, the Order requires:
     No release of the PMN substance, or any waste stream 
containing the PMN substance, into water.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of this protective measure.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of aquatic 
toxicity testing may be potentially useful to characterize the 
environmental effects of the PMN substance. Although the Order does not 
require these tests, the Order's restrictions remain in effect until 
the Order is modified or revoked by EPA based on submission of this or 
other relevant information.

PMN Number: P-20-10 (40 CFR 721.11757)

    Chemical Name: Carboxylic acid, reaction products with metal 
hydroxide, inorganic dioxide and metal (generic).
    CAS Number: Not available.
    Effective Date of TSCA Order: October 15, 2021.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the substance will be as a polymerization 
auxiliary. Based on the potential for chelation of nutrient metals, EPA 
has identified concerns for developmental and blood effects. Based on 
test data on components of the PMN substance and test data on a 
metabolite, EPA has identified concerns for systemic toxicity, 
reproductive and developmental toxicity, genotoxicity, and skin 
sensitization. Based on test data on the PMN substance, EPA predicts 
toxicity to aquatic organisms may occur at concentrations that exceed 
11 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient 
information to permit a reasoned evaluation, the substance may present 
an unreasonable risk of injury to human health or the environment. To 
protect against these risks, the Order requires:
     Use of personal protective equipment where there is a 
potential for dermal exposure;
     Use of a NIOSH-certified particulate respirator with an 
APF of at least 1,000, or an APF of 50 if dust controls are implemented 
that demonstrate an exposure reduction of at least 30% where there is a 
potential for inhalation exposure;
     Establishment of a hazard communication program, including 
human health precautionary statements on each label and in the SDS; and
     No release of the PMN substance resulting in surface water 
concentrations that exceed 11 ppb.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer

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or processor is considering submitting a SNUN for a significant new use 
that will be designated by this SNUR. EPA has determined that the 
results of acute toxicity, skin absorption, skin sensitization, genetic 
toxicity, specific target organ toxicity, reproductive/developmental 
toxicity, and neurotoxicity testing may be potentially useful to 
characterize the health effects of the PMN substance. Although the 
Order does not require these tests, the Order's restrictions remain in 
effect until the Order is modified or revoked by EPA based on 
submission of this or other relevant information.

PMN Numbers: P-20-62 (40 CFR 721.11758), P-20-63 (40 CFR 721.11759), P-
20-64 (40 CFR 721.11760), and P-20-65 (40 CFR 721.11761)

    Chemical Names: Multi-walled carbon nanotubes; closed; 4.4-12.8 nm 
diameter; bundle length 10.6-211.1 [micro]m; Grade: Jenotube 6 (P-20-
62), Multi-walled carbon nanotubes; closed; 5.1-11.6 nm diameter; 
bundle length 1.9-552.0 [micro]m; Grade: Jenotube 8 (P-20-63), Multi-
walled carbon nanotubes; closed; 7.9-14.2 nm diameter; bundle length 
9.4-106.4 [micro]m; Grade: Jenotube 10 (P-20-64), and Multi-walled 
carbon nanotubes; closed; 17.0-34.7 nm diameter; globular shape; Grade: 
Jenotube 20 (P-20-65).
    CAS Numbers: Not available.
    Effective Date of TSCA Order: October 12, 2021.
    Basis for TSCA Order: The PMNs state that the use of the substances 
will be as electrically conductive materials, heat dissipation 
materials, heat generation materials, additives for weight reduction, 
additives to improve physical or mechanical properties, additives in 
batteries, energy storage, and electrode applications, and additives in 
field emission applications. Based on analogy to asbestos fibers and 
data for other multi-walled carbon nanotubes, EPA has identified 
concerns for lung effects (lung overload and lung carcinogenicity) if 
poorly soluble, respirable particulates and fibers are inhaled. Based 
on comparison to analogous chemical substances, EPA has identified 
concerns for eye irritation and systemic effects. Based on the presence 
of cobalt oxide as a residual at 2.1%, EPA has identified concerns for 
the P-20-64 chemical substance for acute neurotoxicity, dermal and 
respiratory sensitization, mutagenicity and carcinogenicity. EPA was 
unable to estimate the environmental hazard of these new chemical 
substances. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) 
and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of 
sufficient information to permit a reasoned evaluation, the substances 
may present an unreasonable risk of injury to human health or the 
environment. To protect against these risks, the Order requires:
     No domestic manufacture (i.e., import only);
     No processing or use of the PMN substances in an 
application method that generates a vapor, mist, dust, or aerosol 
unless such application method occurs in an enclosed process;
     Use of personal protective equipment where there is a 
potential for dermal exposure;
     Use of a NIOSH-certified respirator with an APF of at 
least 50 where there is a potential for inhalation exposure;
     No manufacture of the PMN substances with a maximum weight 
% of cobalt oxide impurity in exceedance of 2.1%;
     Process and use of the PMN substances only as electrically 
conductive materials, heat dissipation materials, heat generation 
materials, additives for weight reduction, additives to improve 
physical or mechanical properties, additives in batteries, energy 
storage, and electrode applications, or as additives in field emission 
applications;
     Establishment of a hazard communication program, including 
human health precautionary statements on each label and in the SDS; and
     No release of the PMN substances, or any waste stream 
containing the PMN substances, into water.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of 
specific target organ toxicity, carcinogenicity, eye irritation, and 
aquatic toxicity testing may be potentially useful to characterize the 
human health and environmental effects of the PMN substances. Although 
the Order does not require these tests, the Order's restrictions remain 
in effect until the Order is modified or revoked by EPA based on 
submission of this or other relevant information.

PMN Number: P-20-70 (40 CFR 721.11762)

    Chemical Name: Nonanamide, N,N-dimethyl.
    CAS Number: 6225-08-7.
    Effective Date of TSCA Order: February 10, 2022.
    Basis for TSCA Order: The PMN states that the use of the substance 
will be as a solvent for use in formulated pesticide products. Based on 
structure and physical/chemical properties, EPA has identified concerns 
for lung effects (surfactancy) and aspiration. Based on submitted test 
data and comparison to analogous chemical substances, EPA has also 
identified concerns for irritation to the skin and eyes, systemic 
effects, and reproductive/developmental effects. Based on comparison to 
an analogous chemical substance, EPA predicts toxicity to aquatic 
organisms may occur at concentrations that exceed 96 ppb. The Order was 
issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), 
based on a finding that in the absence of sufficient information to 
permit a reasoned evaluation, the substance may present an unreasonable 
risk of injury to human health or the environment. To protect against 
these risks, the Order requires:
     Use of personal protective equipment where there is a 
potential for dermal exposure;
     Use of a NIOSH-certified gas/vapor respirator with an APF 
of at least 10 where there is a potential for inhalation exposure;
     No processing use of the PMN substance other than as a 
solvent for use in formulated pesticide products;
     No manufacture of the PMN substance other than by import 
into the United States (i.e., no domestic manufacture) using 20,000 kg 
International Organization for Standardization tank containers 
(ISOtainers) or 1,000 kg intermediate bulk containers (IBCs);
     No release of the PMN substance resulting in surface water 
concentrations that exceed 96 ppb; and
     Establishment of a hazard communication program, including 
human health precautionary statements on each label and in the SDS.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of chronic 
aquatic toxicity testing may be potentially useful to characterize the 
environmental effects of the PMN substance. Although the Order does not 
require these tests, the Order's

[[Page 65553]]

restrictions remain in effect until the Order is modified or revoked by 
EPA based on submission of this or other relevant information.

PMN Number: P-20-84 (40 CFR 721.11763)

    Chemical Name: 2-Propenoic acid, 2-methyl, 2-(dimethylamino)ethyl 
ester, polymers with 2-(C16-18-acylamino)ethyl acrylate and 
hydroxyalkyl acrylate, acetates (salts) (generic).
    CAS Number: Not available.
    Effective Date of TSCA Order: October 20, 2021.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the substance will be as a paper treatment 
additive. Based on the pH of the PMN substance, EPA has identified 
concerns for skin, eye, and respiratory tract irritation. Based on 
analogue data, EPA has also identified concerns for lung effects. The 
Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient 
information to permit a reasoned evaluation, the substance may present 
an unreasonable risk of injury to human health or the environment. To 
protect against these risks, the Order requires:
     Use of personal protective equipment where there is a 
potential for dermal exposure;
     No processing or use of the PMN substance in any manner 
that results in inhalation exposure;
     No use of the PMN substance in a product applied by a 
consumer; and
     Establishment of a hazard communication program, including 
human health precautionary statements on each label and in the SDS.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of 
specific target organ toxicity and pulmonary effects testing may be 
potentially useful to characterize the health effects of the PMN 
substance. Although the Order does not require these tests, the Order's 
restrictions remain in effect until the Order is modified or revoked by 
EPA based on submission of this or other relevant information.

PMN Number: P-20-105 (40 CFR 721.11764)

    Chemical Name: 4H-Pyran-4-one, 3-[(2,5-dihydro-4-methyl-5-oxo-2-
furanyl)oxy]-2-methyl.
    CAS Number: 1333341-34-6.
    Effective Date of TSCA Order: November 9, 2021.
    Basis for TSCA Order: The PMN states that the use of the substance 
will be to promote microbial activity in the soil, resulting in 
increased availability of nutrients in the soil, including nitrogen and 
phosphorus, for crops (for use on commercial farming operations). Based 
on test data on the PMN substance, EPA has identified concerns for skin 
and eye irritation. Based on comparison to analogous substances, EPA 
has also identified concerns systemic effects and reproductive/
developmental effects. Based on comparison to analogous vinyl esters, 
EPA predicts that toxicity to aquatic organisms may occur at 
concentrations that exceed 5 ppb. The Order was issued under TSCA 
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding 
that in the absence of sufficient information to permit a reasoned 
evaluation, the substance may present an unreasonable risk of injury to 
human health or the environment. To protect against these risks, the 
Order requires:
     Use of personal protective equipment where there is a 
potential for dermal exposure;
     Use of a NIOSH-certified particulate respirator with an 
APF of at least 50 where there is a potential for inhalation exposure;
     No processing of the PMN substance other than in a 
facility that employs an on-site sump system used to capture fugitive 
dust releases and disposes the solid waste captured by this sump system 
by landfill;
     No processing of the PMN substance except under negative 
pressure when transferring the substance as a solid material in order 
to minimize exposures to fugitive dust/particulates;
     No domestic manufacture of the PMN substance (i.e., import 
only);
     No use of the PMN substance in a consumer product;
     No use of the PMN substance in spray applications at a 
concentration exceeding 0.01% in formulation;
     No use of the PMN substance other than to promote 
microbial activity in the soil, resulting in increased availability of 
nutrients in the soil, including nitrogen and phosphorus, for crops 
(for use on commercial farming operations); and
     Establishment of a hazard communication program, including 
human health precautionary statements on each label and in the SDS.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of 
specific target organ toxicity and aquatic toxicity testing may be 
potentially useful to characterize the health and environmental effects 
of the PMN substance. Although the Order does not require these tests, 
the Order's restrictions remain in effect until the Order is modified 
or revoked by EPA based on submission of this or other relevant 
information.

PMN Number: P-20-127 (40 CFR 721.11765)

    Chemical Name: 2H-Pyran, tetrahydro-4-methyl.
    CAS Number: 4717-96-8.
    Effective Date of TSCA Order: December 21, 2021.
    Basis for TSCA Order: The PMN states that the use of the substance 
will be as an industrial solvent. Based on submitted test data, EPA has 
identified concerns for aspiration, skin corrosion, serious eye damage, 
systemic effects including central nervous system effects, and 
reproductive and developmental toxicity. Based on comparison to 
analogous neutral organic substances, EPA has determined that toxicity 
to aquatic organisms may occur at concentrations that exceed 540 ppb. 
The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient 
information to permit a reasoned evaluation, the substance may present 
an unreasonable risk of injury to human health or the environment. To 
protect against these risks, the Order requires:
     Use of a NIOSH-certified particulate respirator with an 
APF of at least 50 where there is a potential for inhalation exposure;
     No use of the PMN substance in a consumer product;
     Use of personal protective equipment where there is a 
potential for dermal exposure;
     No release of the PMN substance resulting in surface water 
concentrations that exceed 540 ppb; and
     Establishment of a hazard communication program, including

[[Page 65554]]

human health precautionary statements on each label and in the SDS.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of aquatic 
toxicity testing may be potentially useful to characterize the 
environmental effects of the PMN substance. Although the Order does not 
require these tests, the Order's restrictions remain in effect until 
the Order is modified or revoked by EPA based on submission of this or 
other relevant information.

PMN Number: P-20-130 (40 CFR 721.11766)

    Chemical Name: Organic acid ester, polymer with aliphatic diols and 
1,1'-methylenebis[4-isocyanatobenzene] (generic).
    CAS Number: Not available.
    Effective Date of TSCA Order: March 22, 2022.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the substance will be as a component of industrial 
coatings. Based on a structural alert for isocyanates and information 
provided in the SDS, EPA has identified concerns for dermal and 
respiratory sensitization and lung damage. Based on test data for 
methylene diphenyl diisocyanate (MDI) and other confidential analogous 
chemical substances, EPA has also identified concerns for portal-of-
entry inhalation effects, lung effects, lymph node effects, 
carcinogenicity, genotoxicity, skin and eye irritation, and dermal and 
respiratory sensitization. Based on test data for 4,4'-
Methylenedianiline (MDA), the hydrolysis product of MDI, EPA has 
identified concerns for acute toxicity, clinical signs, genotoxicity, 
carcinogenicity, eye irritation, skin irritation, skin sensitization, 
and body weight, blood, stomach, liver, kidney, thyroid, spleen, 
reproductive, and eye effects. The Order was issued under TSCA sections 
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the 
absence of sufficient information to permit a reasoned evaluation, the 
substance may present an unreasonable risk of injury to human health or 
the environment. To protect against these risks, the Order requires:
     Use of personal protective equipment where there is a 
potential for dermal exposure;
     Use of a NIOSH-certified Gas/Vapor respirator with an APF 
of at least 50 where there is a potential for inhalation exposure;
     Establishment of a hazard communication program, including 
human health precautionary statements on each label and in the SDS;
     No use of the PMN substance in any manner or method that 
involves spray application;
     No use of the PMN substance in a consumer product; and
     No release of the PMN substance to water.
    The proposed SNUR designates as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that would be 
designated by this SNUR. EPA has determined that worker exposure data 
may be potentially useful to characterize human health effects of the 
PMN substance. Although the Order does not require this, the Order's 
restrictions remain in effect until the Order is modified or revoked by 
EPA based on submission of this or other relevant information.

PMN Number: P-21-3 (40 CFR 721.11767)

    Chemical Name: 4,4-Methylenebis (2,6-dimethyl phenol) polymer with 
2-(chloromethyl)oxirane, 1,4-benzene diol, 2-methyl-2-propenoic acid, 
mixed alkyl substituted 2-methyl 2-propenoate, and ethyl 2-propenoate, 
reaction products with 2-(dimethylamino) ethanol (generic).
    CAS Number: Not available.
    Effective Date of TSCA Order: March 10, 2022.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the substance will be as a polymeric film former 
for coatings. Based on structural alerts for amines and acid groups, 
EPA has identified concerns for irritation to the skin, eyes, and 
respiratory tract. Based on a potential metabolite released from the 
anion, EPA has identified concerns for developmental effects. Based on 
potential for chelation of nutrient metals by the acid groups of the 
anion, EPA has also identified developmental, blood, liver, and kidney 
effects. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient 
information to permit a reasoned evaluation, the substance may present 
an unreasonable risk of injury to human health or the environment. To 
protect against these risks, the Order requires:
     Use of personal protective equipment where there is a 
potential for dermal exposure;
     Use of a NIOSH-certified Gas/Vapor respirator with an APF 
of at least 10 where there is a potential for inhalation exposure;
     No use of the PMN substance in a consumer product; and
     Establishment of a hazard communication program, including 
human health precautionary statements on each label and in the SDS.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of 
developmental toxicity, skin irritation, and eye damage testing may be 
potentially useful to characterize the health effects of the PMN 
substance. Although the Order does not require these tests, the Order's 
restrictions remain in effect until the Order is modified or revoked by 
EPA based on submission of this or other relevant information.

PMN Numbers: P-21-28 (40 CFR 721.11768) and P-21-29 (40 CFR 721.11769)

    Chemical Names: Phenol, methylethylidene, polymer chloromethyl 
epoxide and methylethylidene bis-oxy, bis-amine (generic) (P-21-28) and 
Amine, methylethylidene bis(oxy) (generic) (P-21-29).
    CAS Numbers: Not available.
    Effective Date of TSCA Order: November 9, 2021.
    Basis for TSCA Order: The PMNs state that the use of the substances 
will be as an epoxy polymer used in reaction to make epoxy (P-21-28) 
and an epoxy monomer used in polymer reactions (P-21-29). Based on test 
data on the residual and an analogue, EPA has identified concerns for 
corrosion to the skin, eyes, and respiratory tract, acute toxicity, 
systemic effects, irritation to the skin and eyes, and skin 
sensitization. Based on analogy to diamines, EPA has identified 
concerns

[[Page 65555]]

for respiratory sensitization. Based on comparison to analogous 
aliphatic amines, EPA predicts that toxicity to aquatic organisms may 
occur at concentrations that exceed 100 ppb (for P-21-28) and 840 ppb 
(for P-21-29). The Order was issued under TSCA sections 
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the 
absence of sufficient information to permit a reasoned evaluation, the 
substances may present an unreasonable risk of injury to human health 
or the environment. To protect against these risks, the Order requires:
     Use of personal protective equipment where there is a 
potential for dermal exposure;
     Use of a NIOSH-certified particulate respirator with an 
APF of at least 50 for non-spray applications or 1,000 for spray 
applications where there is a potential for inhalation exposure (P-21-
28);
     Use of a NIOSH-certified gas/vapor respirator with an APF 
of at least 50 (non-spray applications) or a NIOSH-certified 
combination particulate and gas/vapor respirator with an APF of at 
least 1,000 (spray applications) where there is a potential for 
inhalation exposure (P-21-29);
     Establishment of a hazard communication program, including 
human health precautionary statements on each label and in the SDS; and
     No release of the PMN substances resulting in surface 
water concentrations that exceed 100 ppb for P-21-28 or 840 ppb for P-
21-29.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of 
metabolism or pharmacokinetics, specific target organ toxicity, skin 
irritation/corrosion, skin irritation/eye damage, skin sensitization, 
aquatic toxicity (P-21-28), and chronic aquatic toxicity (P-21-29) 
testing may be potentially useful to characterize the human health and 
environmental effects of the PMN substances. Although the Order does 
not require these tests, the Order's restrictions remain in effect 
until the Order is modified or revoked by EPA based on submission of 
this or other relevant information.

PMN Number: P-21-34 (40 CFR 721.11770)

    Chemical Name: Carbamic acid, N-[3-(trialkoxysilyl)propyl]-, C,C'-
[2,2,4(or 2,4,4)-trimethyl-1,6-hexanediyl] ester (generic).
    CAS Number: Not available.
    Effective Date of TSCA Order: February 27, 2022.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the substances will be as a crosslinker for 
automotive coatings and a crosslinker for wood and plastic coatings. 
Based on comparison to analogous substances, EPA has identified 
concerns for respiratory tract effects and systemic, reproductive, and 
developmental effects. Based on comparison to analogous alkoxysilanes, 
EPA has determined that toxicity to aquatic organisms may occur at 
concentrations that exceed 1 ppb. The Order was issued under TSCA 
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding 
that in the absence of sufficient information to permit a reasoned 
evaluation, the substance may present an unreasonable risk of injury to 
human health or the environment. To protect against these risks, the 
Order requires:
     No release of the PMN substance resulting in surface water 
concentrations that exceed 1 ppb; and
     Establishment of a hazard communication program, including 
human health precautionary statements on each label and in the SDS.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of 
metabolism or pharmacokinetics, specific target organ toxicity, 
reproductive toxicity, developmental toxicity, and biodegradation 
testing may be potentially useful to characterize the health and fate 
effects of the PMN substance. Although the Order does not require these 
tests, the Order's restrictions remain in effect until the Order is 
modified or revoked by EPA based on submission of this or other 
relevant information.

PMN Number: P-21-67 (40 CFR 721.11771)

    Chemical Name: Arylfurandione, [bis(trihaloalkyl)alkylidene]bis-, 
polymer with alkanediamine (generic).
    CAS Number: Not available.
    Effective Date of TSCA Order: December 8, 2021.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the substance will be as a polymer used in the 
manufacture of films. Based on the high molecular weight and low water 
solubility of the PMN substance, EPA has identified concerns for lung 
effects. Based on structural alerts and information provided in the 
SDS, EPA has also identified concerns for dermal irritation. For the 
incineration product, EPA has identified concerns for systemic effects. 
The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient 
information to permit a reasoned evaluation, the substance may present 
an unreasonable risk of injury to human health or the environment. To 
protect against these risks, the Order requires:
     Manufacture or processing of the PMN substance only at a 
particle size of 10 microns or greater;
     Use of personal protective equipment where there is a 
potential for dermal exposure;
     Whenever the PMN substance or waste streams containing the 
PMN substance are disposed of by incineration, such incineration must 
occur at a minimum temperature of 870 degrees Celsius; and
     Establishment of a hazard communication program, including 
human health precautionary statements on each label and in the SDS.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of skin 
irritation testing may be potentially useful to characterize the health 
effects of the PMN substance. Although the Order does not require these 
tests, the Order's restrictions remain in effect until the Order is 
modified or revoked by EPA based on submission of this or other 
relevant information.

PMN Number: P-21-93 (40 CFR 721.11772)

    Chemical Name: Phosphonic acid, dimethyl ester, reaction products 
with alkyl-alkyl-alkanedial and alkanediol (generic).
    CAS Number: Not available.

[[Page 65556]]

    Effective Date of TSCA Order: December 1, 2021.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the substance will be as an anti-wear additive for 
lubricants. Based on a test data on the PMN substance, EPA has 
identified concerns for skin corrosion, developmental toxicity, 
neurotoxicity, and systemic effects. Based on information provided in 
the SDS, EPA has also identified concerns for skin corrosion, serious 
eye damage, respiratory tract irritation, and developmental toxicity. 
Based on residual feedstock and the potential for methanol release, EPA 
has also identified concerns for eye irritation, systemic toxicity, 
neurotoxicity, and developmental effects. Based on comparison to 
analogous esters, EPA predicts toxicity to aquatic organisms may occur 
at concentrations that exceed 180 ppb. The Order was issued under TSCA 
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding 
that in the absence of sufficient information to permit a reasoned 
evaluation, the substance may present an unreasonable risk of injury to 
human health or the environment. To protect against these risks, the 
Order requires:
     Use of personal protective equipment where there is a 
potential for dermal exposure;
     No manufacture, processing, or use of the PMN substance in 
any manner that generates a dust, mist, particulate, or aerosol that 
results in inhalation exposure;
     No use of the PMN substance in consumer products where the 
concentration of the PMN substance equals or exceeds 3%;
     No release of the PMN substance resulting in surface water 
concentrations that exceed 180 ppb; and
     Establishment of a hazard communication program, including 
human health precautionary statements on each label and in the SDS.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of aquatic 
toxicity and fate testing may be potentially useful to characterize the 
environmental effects of the PMN substance. Although the Order does not 
require these tests, the Order's restrictions remain in effect until 
the Order is modified or revoked by EPA based on submission of this or 
other relevant information.

PMN Number: P-21-94 (40 CFR 721.11773)

    Chemical Name: Silane, halogenated (generic).
    CAS Number: Not available.
    Effective Date of TSCA Order: January 20, 2022.
    Basis for TSCA Order: The PMN states that the use of the substance 
will be as a deposition precursor for the manufacture of electronic 
components. Based on the reactivity of the PMN substance, information 
in the SDS, and analogue data for dichlorosilane and silicon 
tetrachloride, EPA has identified concerns for corrosion to skin, eyes, 
and the respiratory tract. Based on analogue test data for 
dichlorosilane, EPA has also identified concerns for systemic effects. 
Based on test data on a disassociation product, EPA has also identified 
concerns for thyroid effects, immunotoxicity, and developmental 
neurotoxicity. Based on comparison to an analogous chemical substance, 
EPA predicts that toxicity to aquatic organisms may occur at 
concentrations that exceed 3 ppb. The Order was issued under TSCA 
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding 
that in the absence of sufficient information to permit a reasoned 
evaluation, the substance may present an unreasonable risk of injury to 
human health or the environment. To protect against these risks, the 
Order requires:
     Use of personal protective equipment where there is a 
potential for dermal exposure;
     Use of a NIOSH-certified respirator with an APF of at 
least 1,000 where there is a potential for inhalation exposure, or 
compliance with an NCEL of 0.05 mg/m\3\ as an 8-hour time-weighted 
average to prevent inhalation exposure;
     No use of the PMN substance other than as a deposition 
precursor in the manufacture of electronic components;
     No release of the PMN substance resulting in surface water 
concentrations that exceed 3 ppb; and
     Establishment of a hazard communication program, including 
human health precautionary statements on each label and in the SDS.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of skin 
corrosion, eye damage, specific target organ toxicity, pulmonary 
effects, developmental neurotoxicity, and aquatic toxicity testing may 
be potentially useful to characterize the health and environmental 
effects of the PMN substance. Although the Order does not require these 
tests, the Order's restrictions remain in effect until the Order is 
modified or revoked by EPA based on submission of this or other 
relevant information.

PMN Number: P-21-115 (40 CFR 721.11774)

    Chemical Name: Heteromonocycle, polymer, substituted aliphatic 
carbamate, [2-[(1-oxo-2-propen-1-yl)oxy]alkyl]ester (generic).
    CAS Number: Not available.
    Effective Date of TSCA Order: November 3, 2021.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the substance will be as a raw material for 
industrial additive manufacturing, UV-curable inks, coatings, and 
adhesives. Based on the presence of bifunctional acrylates and 
information provided in the TSCA New Chemical Program Chemical 
Categories for acrylates, EPA has identified concerns for irritation to 
the skin, eyes, and respiratory tract, and skin and respiratory 
sensitization. The Order was issued under TSCA sections 
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the 
absence of sufficient information to permit a reasoned evaluation, the 
substance may present an unreasonable risk of injury to human health or 
the environment. To protect against these risks, the Order requires:
     Use of personal protective equipment where there is a 
potential for dermal exposure;
     Use of a NIOSH-certified particulate respirator with an 
APF of at least 50, or of at least 1,000 when spray applied, where 
there is a potential for inhalation exposure;
     No use of the PMN substance in a consumer product; and
     Establishment of a hazard communication program, including 
human health precautionary statements on each label and in the SDS.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer

[[Page 65557]]

or processor is considering submitting a SNUN for a significant new use 
that will be designated by this SNUR. EPA has determined that the 
results of skin irritation, sensitization, and eye damage testing may 
be potentially useful to characterize the health effects of the PMN 
substance. Although the Order does not require these tests, the Order's 
restrictions remain in effect until the Order is modified or revoked by 
EPA based on submission of this or other relevant information.

PMN Number: P-21-141 (40 CFR 721.11775)

    Chemical Name: Alkanes, C4-8-branched and linear.
    CAS Number: 2529890-37-5.
    Effective Date of TSCA Order: January 4, 2022.
    Basis for TSCA Order: The PMN states that the use of the substance 
will be as a transportation fuel. Based on the constituents of the PMN 
substance, EPA has identified concerns for skin and eye irritation, 
respiratory depression/irritation, acute toxicity, neurotoxicity, 
systemic toxicity, neurotoxicity, body weight effects, reproductive and 
developmental toxicity, and genotoxicity. Based on an analogue mixture, 
EPA has also identified concerns for respiratory tract effects and 
carcinogenicity. Based on the chemical composition as a petroleum 
replacement, EPA has also identified concerns for hydrocarbon 
pneumonia/aspiration. Based on comparison to analogous neutral organic 
substances, EPA predicts toxicity to aquatic organisms may occur at 
concentrations that exceed 3 ppb. The Order was issued under TSCA 
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding 
that in the absence of sufficient information to permit a reasoned 
evaluation, the substance may present an unreasonable risk of injury to 
human health or the environment. To protect against these risks, the 
Order requires:
     Use of personal protective equipment where there is a 
potential for dermal exposure; and
     No manufacturing, processing, or use of the PMN substance 
other than for use as a transportation fuel, refinery feedstock; or 
fuel blending additive.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of skin 
irritation, eye irritation, respiratory depression/irritation, 
hydrocarbon pneumonia/aspiration, reproductive and developmental 
toxicity, systemic toxicity, genotoxicity, carcinogenicity, and aquatic 
toxicity testing may be potentially useful to characterize the health 
and environmental effects of the PMN substance. Although the Order does 
not require these tests, the Order's restrictions remain in effect 
until the Order is modified or revoked by EPA based on submission of 
this or other relevant information.

PMN Number: P-21-196 (40 CFR 721.11776)

    Chemical Name: 5H-1,2-Oxathiole, 2,2-dioxide.
    CAS Number: 21806-61-1.
    Effective Date of TSCA Order: June 20, 2022.
    Basis for TSCA Order: The PMN states that the use of the substance 
will be as an additive in battery electrolyte formulations. Based on 
information provided in the SDS, EPA has identified concerns for acute 
toxicity, eye irritation, genotoxicity, and carcinogenicity. Based on 
OECD Toolbox results, EPA has identified concerns for skin 
sensitization. Based on submitted test data, EPA has identified 
concerns for acute toxicity, skin sensitization, genotoxicity, 
neurotoxicity, reproductive, and developmental effects. Based on 
alkylating potential of the PMN substance, EPA has identified concerns 
for eye irritation, skin sensitization, acute toxicity, genotoxicity, 
carcinogenicity, and liver and developmental effects. Based on test 
data for analogous substance, EPA has also identified concerns for 
acute toxicity, clinical signs, eye irritation and corrosion, 
genotoxicity, and carcinogenicity. Based on submitted test data, EPA 
predicts toxicity to aquatic organisms may occur at concentrations that 
exceed 23 ppb. The Order was issued under TSCA sections 
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the 
absence of sufficient information to permit a reasoned evaluation, the 
substance may present an unreasonable risk of injury to human health or 
the environment. To protect against these risks, the Order requires:
     Manufacture of the PMN substance only by import into the 
United States (i.e., no domestic manufacture).
     Process and use of the PMN substance only in an enclosed 
process except that sampling and equipment cleaning operations need not 
occur in an enclosed process. During sampling and equipment cleaning 
operations each person is required to wear a National Institute for 
Occupational Safety and Health (NIOSH)-certified full-face respirator 
with an Assigned Protection Factor (APF) of 1,000 and dermal personal 
protective equipment.
     Establishment of a hazard communication program, including 
human health precautionary statements on each label and in the SDS; and
     Disposal of the PMN substance only by incineration with 
99.9% efficiency.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of 
neurotoxicity, carcinogenicity, and aquatic toxicity testing may be 
potentially useful to characterize the human health and environmental 
effects of the PMN substance. Although the Order does not require these 
tests, the Order's restrictions remain in effect until the Order is 
modified or revoked by EPA based on submission of this or other 
relevant information.

VI. Applicability of the Proposed Significant New Use Designation

    To establish a significant new use, EPA must determine that the use 
is not ongoing. The chemical substances subject to this proposed rule 
have undergone premanufacture review. In cases where EPA has not 
received a notice of commencement (NOC) and the chemical substance has 
not been added to the TSCA Inventory, no person may commence such 
activities without first submitting a PMN. Therefore, for chemical 
substances for which an NOC has not been submitted EPA concludes that 
the designated significant new uses are not ongoing.
    When chemical substances identified in this proposed rule are added 
to the TSCA Inventory, EPA recognizes that, before the rule is 
effective, other persons might engage in a use that has been identified 
as a significant new use. However, TSCA Orders have been issued for 
these chemical substances, and the PMN submitters are prohibited by the 
TSCA Orders from undertaking activities which would be designated as 
significant new uses. The identities of many of the chemical substances 
subject to this proposed rule have been claimed as confidential per 40 
CFR 720.85. Based on this, the Agency believes that

[[Page 65558]]

it is highly unlikely that any of the significant new uses described in 
the regulatory text of this proposed rule are ongoing.
    EPA designates October 31, 2022 as the cutoff date for determining 
whether the new use is ongoing. The objective of EPA's approach is to 
ensure that a person cannot defeat a SNUR by initiating a significant 
new use before the effective date of the final rule.
    In the unlikely event that a person began commercial manufacture or 
processing of the chemical substances for a significant new use 
identified as of that date 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 EPA has conducted a review of 
the notice, made an appropriate determination on the notice, and has 
taken such actions as are required with that determination.
    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.

VII. Development and Submission of Information

    EPA recognizes that TSCA section 5 does not require developing 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, TSCA 
Order or consent agreement under TSCA section 4, then TSCA section 
5(b)(1)(A) requires such information to be submitted to EPA at the time 
of submission of the SNUN.
    In the absence of a rule, 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 or reasonably ascertainable (see 40 CFR 
720.50). However, upon review of PMNs and SNUNs, the Agency has the 
authority to require appropriate testing. Unit V. lists potentially 
useful information for the SNURs listed in this document. Descriptions 
of this information is provided for informational purposes. The 
potentially useful information identified in Unit V. will be useful to 
EPA's evaluation in the event that someone submits a SNUN for the 
significant new use.
    EPA strongly encourages persons, before performing any testing, to 
consult with the Agency. Furthermore, pursuant to TSCA section 4(h), 
which pertains to reduction of testing in vertebrate animals, EPA 
encourages dialog 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.
    In some of the TSCA Orders for the chemical substances identified 
in this rule, EPA has established time limits in view of the lack of 
data on the potential health and environmental risks that may be posed 
by the significant new uses or increased exposure to the chemical 
substances. These limits cannot be exceeded unless the PMN submitter 
first submits the results of specified tests that would permit a 
reasoned evaluation of the potential risks posed by these chemical 
substances. The SNURs contain the same time limits as the TSCA Orders. 
Exceeding these production limits is defined as a significant new use. 
Persons who intend to exceed the time limit must notify the Agency by 
submitting a SNUN at least 90 days in advance of commencement of non-
exempt commercial manufacture or processing.
    Any request by EPA for the triggered and pended testing described 
in the TSCA Orders was made based on EPA's consideration of available 
screening-level data, if any, as well as other available information on 
appropriate testing for the PMN substances. Further, any such testing 
request on the part of EPA that includes testing on vertebrates was 
made after consideration of available toxicity information, 
computational toxicology and bioinformatics, and high-throughput 
screening methods and their prediction models.
    The potentially useful information listed in Unit V. may not be the 
only means of addressing the potential risks of the chemical substance. 
However, submitting a SNUN without any test data or other information 
may increase the likelihood that EPA will take action under TSCA 
section 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 on the following:
     Human exposure and environmental release that may result 
from the significant new use of the chemical substances.
     Information on risks posed by the chemical substances 
compared to risks posed by potential substitutes.

VIII. SNUN Submissions

    According to 40 CFR 721.1(c), persons submitting a SNUN must comply 
with the same notification requirements and EPA regulatory procedures 
as persons submitting a PMN, including submission of test data on 
health and environmental effects as described in 40 CFR 720.50. 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. E-PMN software is available electronically 
at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.

IX. Economic Analysis

    EPA has evaluated the potential costs of establishing SNUN 
requirements for potential manufacturers and processors of the chemical 
substances subject to this proposed rule. EPA's complete economic 
analysis is available in the docket for this rulemaking.

X. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive orders 
can be found at https://www.epa.gov/laws-regulations-and-executive-orders.

A. Executive Orders 12866: Regulatory Planning and Review and 13563: 
Improving Regulations and Regulatory Review

    This action proposes to establish SNURs for several 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 Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 
3821, January 21, 2011).

B. Paperwork Reduction Act (PRA)

    According to the PRA (44 U.S.C. 3501 et seq.), an agency may not 
conduct or sponsor, and a person is not required to respond to a 
collection of information that requires OMB approval under PRA,

[[Page 65559]]

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 activities associated with SNURs have 
already been approved by OMB under the PRA and assigned OMB control 
number 2070-0012 (EPA ICR No. 574). This proposed rule does not contain 
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 response. 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.
    Send any comments about the accuracy of the burden estimate, and 
any suggested methods for minimizing respondent burden, including using 
automated collection techniques, to the Director, Regulatory Support 
Division, Office of Mission Support (2822T), Environmental Protection 
Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001. Please 
remember to include the OMB control number in any correspondence, but 
do not submit any completed forms to this address.

C. Regulatory Flexibility Act (RFA)

    Pursuant to the RFA section 605(b) (5 U.S.C. 601 et seq.), the 
Agency hereby certifies that promulgation of these SNURs would not have 
a significant adverse economic impact on a substantial number of small 
entities. 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, it appears 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. 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 seven in Federal fiscal year (FY) 2013, 13 
in FY2014, six in FY2015, 10 in FY2016, 14 in FY2017, and 18 in FY2018 
and only a fraction of these were from small businesses. In addition, 
the Agency currently offers relief to qualifying small businesses by 
reducing the SNUN submission fee from $19,020 to $3,330. This lower fee 
reduces the total reporting and recordkeeping of cost of submitting a 
SNUN to about $11,164 for qualifying small firms. Therefore, the 
potential economic impacts of complying with this proposed SNUR 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 final SNURs are not expected to have a 
significant economic impact on a substantial number of small entities, 
which was provided to the Chief Counsel for Advocacy of the Small 
Business Administration.

D. Unfunded Mandates Reform Act (UMRA)

    Based on EPA's experience with proposing and finalizing SNURs, 
State, local, and Tribal governments have not been impacted by these 
rulemakings, and EPA does not have any reasons to believe that any 
State, local, or Tribal government will be impacted by this action. As 
such, EPA has determined that this proposed rule would not impose any 
enforceable duty, contain any unfunded mandate, or otherwise have any 
effect on small governments subject to the requirements of UMRA 
sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.).

E. Executive Order 13132: Federalism

    This action would not 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, as specified in Executive Order 13132 (64 FR 
43255, August 10, 1999).

F. Executive Order 13175: Consultation and Coordination With Indian 
Tribal Governments

    This action would 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. This 
action would not significantly nor uniquely affect the communities of 
Indian Tribal governments, nor would it involve or impose any 
requirements that affect Indian Tribes.

G. Executive Order 13045: Protection of Children From Environmental 
Health Risks and Safety Risks

    This action is not subject to Executive Order 13045 (62 FR 19885, 
April 23, 1997), because this is not an economically significant 
regulatory action as defined by Executive Order 12866, and this action 
does not address environmental health or safety risks 
disproportionately affecting children.

H. Executive Order 13211: Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use

    This action is not subject to Executive Order 13211 (66 FR 28355, 
May 22, 2001), because this action is not expected to affect energy 
supply, distribution, or use and because this action has not otherwise 
been designated as a significant energy action by the Administrator of 
OMB's Office of Information and Regulatory Affairs.

I. National Technology Transfer and Advancement Act (NTTAA)

    This action does not involve any technical standards subject to 
NTTAA section 12(d) (15 U.S.C. 272 note).

J. Executive Orders 12898: Federal Actions To Address Environmental 
Justice in Minority Populations and Low-Income Populations and 14008: 
Tackling the Climate Crisis at Home and Abroad

    EPA believes that this action is not subject to Executive Orders 
12898 (59 FR 7629, February 16, 1994) and 14008 (86 FR 7619, January 
27, 2021) because it does not establish an environmental health or 
safety standard.

List of Subjects in 40 CFR Part 721

    Environmental protection, Chemicals, Hazardous substances, 
Reporting and recordkeeping requirements.

    Dated: October 20, 2022.
Tala Henry,
Deputy Director, Office of Pollution Prevention and Toxics.
    Therefore, for the reasons stated in the preamble, it is proposed 
that 40 CFR chapter I be 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.  721.11752 through 721.11776 to subpart E to read as 
follows:

[[Page 65560]]

Subpart E--Significant New Uses for Specific Chemical Substances

Sec.
* * * * *
721.11752 Quaternary ammonium salt of polyisobutene succinic acid 
(generic).
721.11753 2-Propenoic acid, 2-alkyl-, 2-(dialkylamino)alkyl ester, 
polymer with alpha-(2-alkyl-1-oxo-2-alken-1-yl)-omega-
methoxypoly(oxy-1,2-alkanediyl) (generic).
721.11754 Alkanedioic acid, polymer with cycloalkyl dimethanol, 
alkyl and cycloalkyl diisocyanates, dimethyl-alkanediol, 
dihydroxyalkanoic acid methylenebis[isocyanatocyclohexane, 
hydroxyethyl acrylate- and polyalkyl glycol monoalkyl ether blocked 
(generic)
721.11755 Poly(oxy-1,4-butanediyl), alpha-hydro-omega-hydroxy-, 
polymer with 1,1'-methylenebis[4-isocyanatobenzene),caprolactam-
blocked.
721.11756 Tall oil pitch, fraction, sterol-low (generic).
721.11757 Carboxylic acid, reaction products with metal hydroxide, 
inorganic dioxide and metal (generic).
721.11758 Multi-walled carbon nanotubes; closed; 4.4-12.8 nm 
diameter; bundle length 10.6-211.1 [micro]m; Grade: Jenotube 6.
721.11759 Multi-walled carbon nanotubes; closed; 5.1-11.6 nm 
diameter; bundle length 1.9-552.0 [micro]m; Grade: Jenotube 8.
721.11760 Multi-walled carbon nanotubes; closed; 7.9-14.2 nm 
diameter; bundle length 9.4-106.4 [micro]m; Grade: Jenotube 10.
721.11761 Multi-walled carbon nanotubes; closed; 17.0-34.7 nm 
diameter; globular shape; Grade: Jenotube 20.
721.11762 Nonanamide, N,N-dimethyl.
721.11763 2-Propenoic acid, 2-methyl, 2-(dimethylamino)ethyl ester, 
polymers with 2-(C16-18-acylamino)ethyl acrylate and hydroxyalkyl 
acrylate, acetates (salts) (generic).
721.11764 4H-Pyran-4-one, 3-[(2,5-dihydro-4-methyl-5-oxo-2-
furanyl)oxy]-2-methyl.
721.11765 2H-Pyran, tetrahydro-4-methyl.
721.11766 Organic acid ester, polymer with aliphatic diols and 1,1'-
methylenebis[4-isocyanatobenzene] (generic).
721.11767 4,4-Methylenebis (2,6-dimethyl phenol) polymer with 2-
(chloromethyl)oxirane, 1,4-benzene diol, 2-methyl-2-propenoic acid, 
mixed alkyl substituted 2-methyl 2-propenoate, and ethyl 2-
propenoate, reaction products with 2-(dimethylamino) ethanol 
(generic). 21-3
721.11768 Phenol, methylethylidene, polymer chloromethyl epoxide and 
methylethylidene bis-oxy, bis-amine (generic).
721.11769 Amine, methylethylidene bis(oxy) (generic)
721.11770 Carbamic acid, N-[3-(trialkoxysilyl)propyl]-, C,C'-
[2,2,4(or 2,4,4)-trimethyl-1,6-hexanediyl] ester (generic).
721.11771 Arylfurandione, [bis(trihaloalkyl)alkylidene]bis-, polymer 
with alkanediamine (generic).
721.11772 Phosphonic acid, dimethyl ester, reaction products with 
alkyl-alkyl-alkanediol and alkanediol (generic).
721.11773 Silane, halogenated (generic).
721.11774 Heteromonocycle, polymer, substituted aliphatic carbamate, 
[2-[(1-oxo-2-propen-1-yl)oxy]alkyl]ester (generic).
721.11775 Alkanes, C4-8-branched and linear.
721.11776 5H-1,2-Oxathiole, 2,2-dioxide.
* * * * *


Sec.  721.11752   Quaternary ammonium salt of polyisobutene succinic 
acid (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
quaternary ammonium salt of polyisobutene succinic acid (PMN P-16-349) 
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)(3), (6)(vii), (7), and (c). 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)(ix), (2)(i) and (v), and (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.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k). It is a significant new use to 
manufacture, process, or use the substance in any manner that results 
in inhalation exposure. It is a significant new use to use the 
substance in any consumer product to be added to gasoline or diesel 
fuels by the consumer.
    (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 and processors 
of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11753   2-Propenoic acid, 2-alkyl-, 2-(dialkylamino)alkyl 
ester, polymer with alpha-(2-alkyl-1-oxo-2-alken-1-yl)-omega-
methoxypoly(oxy-1,2-alkanediyl) (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 2-
propenoic acid, 2-alkyl-, 2-(dialkylamino)alkyl ester, polymer with 
alpha-(2-alkyl-1-oxo-2-alken-1-yl)-omega-methoxypoly(oxy-1,2-
alkanediyl) (PMN P-18-27) 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) or when 
present as an impurity at less than 1% by weight.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(3), (5) through (8), and (c). 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 of at least 1,000 during spray applications.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1), and (5). For purposes of Sec.  
721.72(g)(1), this substance may cause: specific target organ toxicity; 
skin irritation; eye irritation; skin sensitization. Alternative hazard 
and warning statements that meet the criteria of the Globally 
Harmonized System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. It is a 
significant new use to use the substance in formulations at greater 
than 0.1% for spray applications.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11754   Alkanedioic acid, polymer with cycloalkyl dimethanol, 
alkyl and cycloalkyl diisocyanates, dimethyl-alkanediol, 
dihydroxyalkanoic acid methylenebis [isocyanatocyclohexane, 
hydroxyethyl acrylate- and polyalkyl glycol monoalkyl ether blocked 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
alkanedioic acid, polymer with cycloalkyl dimethanol, alkyl and 
cycloalkyl diisocyanates, dimethyl-alkanediol, dihydroxyalkanoic acid 
methylenebis [isocyanatocyclohexane, hydroxyethyl acrylate- and 
polyalkyl

[[Page 65561]]

glycol monoalkyl ether blocked (PMN P-18-301) 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)(3), (7), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1), and (5). For purposes of Sec.  
721.72(g)(1), this substance may cause: skin irritation; skin 
sensitization; eye irritation; respiratory sensitization. Alternative 
hazard and warning statements that meet the criteria of the Globally 
Harmonized System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o).
    (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.  721.11755   Poly(oxy-1,4-butanediyl), alpha-hydro-omega-hydroxy-, 
polymer with 1,1'-methylenebis[4-isocyanatobenzene), caprolactam-
blocked.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as poly(oxy-1,4-
butanediyl), alpha-hydro-omega-hydroxy-, polymer with 1,1'-
methylenebis[4-isocyanatobenzene),caprolactam-blocked (P-18-340; CAS 
No. 2247074-17-3) 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 (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(3) and (7), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1), and (5). For purposes of Sec.  
721.72(g)(1), this substance may cause: respiratory sensitization; skin 
sensitization; 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 use the 
substance other than for one component thermoset elastomer manufacture. 
It is a significant new use to manufacture, process, or use the 
substance in any manner that results in inhalation exposure. It is a 
significant new use to manufacture the substance without the use of a 
packed tower scrubber that removes at least 95 percent of the substance 
prior to release.
    (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.  721.11756   Tall oil pitch, fraction, sterol-low (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as tall 
oil pitch, fraction, sterol-low (PMN P-19-165) 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) Release to water. Requirements as specified in Sec.  
721.90(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), 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.  721.11757   Carboxylic acid, reaction products with metal 
hydroxide, inorganic dioxide and metal (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
carboxylic acid, reaction products with metal hydroxide, inorganic 
dioxide and metal (PMN P-20-10) 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 
(cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(3), (5), (6)(vii), (7), (8), and (c). For purposes of Sec.  
721.63(a)(5), respirators must provide a National Institute for 
Occupational Safety and Health (NIOSH) assigned protection factor (APF) 
of at least 1,000, or an APF of 50 if dust controls are implemented 
that demonstrate an exposure reduction of at least 30%.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1), (3)(iii), and (5). For purposes of 
Sec.  721.72(g)(1), this substance may cause: 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) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N=11.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (h), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11758   Multi-walled carbon nanotubes; closed; 4.4-12.8 nm 
diameter; bundle length 10.6-211.1 [mu]m; Grade: Jenotube 6.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as multi-walled carbon 
nanotubes; closed; 4.4-12.8 nm diameter; bundle length 10.6-211.1 
[mu]m; Grade: Jenotube 6 (PMN P-20-62) 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 or incorporated into an article.
    (2) The significant new uses are:

[[Page 65562]]

    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(3), (5), (6)(vii), (7), (8), and (c). For purposes of Sec.  
721.63(a)(5), respirators must provide a National Institute for 
Occupational Safety and Health (NIOSH) assigned protection factor (APF) 
of at least 50.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1), (3)(iii), and (5). For purposes of 
Sec.  721.72(g)(1), this substance may cause: skin sensitization; eye 
irritation; respiratory 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(f). It is a significant new use to 
manufacture the substance with a maximum weight percent of cobalt oxide 
impurity in excess of 2.1%. It is a significant new use to process or 
use the substance other than as an electrically conductive material, a 
heat dissipation material, a heat generation material, an additive for 
weight reduction, an additive to improve physical or mechanical 
properties, an additive in batteries, energy storage, and electrode 
applications, or an additive in field emission applications. It is a 
significant new use to process or use the substance in application 
methods that do not generate a vapor, mist, dust, or aerosol unless 
such an application method occurs in an enclosed process.
    (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.  721.11759   Multi-walled carbon nanotubes; closed; 5.1-11.6 nm 
diameter; bundle length 1.9-552.0 mm; Grade: Jenotube 8.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as multi-walled carbon 
nanotubes; closed; 5.1-11.6 nm diameter; bundle length 1.9-552.0 [mu]m; 
Grade: Jenotube 8 (PMN P-20-63) 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 or incorporated into an article.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(3), (5), (6)(vii), (7), (8), and (c). For purposes of Sec.  
721.63(a)(5), respirators must provide a National Institute for 
Occupational Safety and Health (NIOSH) assigned protection factor (APF) 
of at least 50.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1), (3)(iii), and (5). For purposes of 
Sec.  721.72(g)(1), this substance may cause: skin sensitization; eye 
irritation; respiratory 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(f). It is a significant new use to 
manufacture the substance with a maximum weight percentage of cobalt 
oxide impurity in excess of 2.1%. It is a significant new use to 
process or use the substance other than as an electrically conductive 
material, a heat dissipation material, a heat generation material, an 
additive for weight reduction, an additive to improve physical or 
mechanical properties, an additive in batteries, energy storage, and 
electrode applications, or an additive in field emission applications. 
It is a significant new use to process or use the substance in 
application methods that do not generate a vapor, mist, dust, or 
aerosol unless such an application method occurs in an enclosed 
process.
    (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.  721.11760   Multi-walled carbon nanotubes; closed; 7.9-14.2 nm 
diameter; bundle length 9.4-106.4 mm; Grade: Jenotube 10.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as multi-walled carbon 
nanotubes; closed; 7.9-14.2 nm diameter; bundle length 9.4-106.4 [mu]m; 
Grade: Jenotube 10 (PMN P-20-64) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section. The requirements of this section do not apply to 
quantities of the substance after they have been completely reacted or 
cured or incorporated into an article.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(3), (5), (6)(vii), (7), (8), and (c). For purposes of Sec.  
721.63(a)(5), respirators must provide a National Institute for 
Occupational Safety and Health (NIOSH) assigned protection factor (APF) 
of at least 50.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1), (3)(iii), and (5). For purposes of 
Sec.  721.72(g)(1), this substance may cause: skin sensitization; eye 
irritation; respiratory 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(f). It is a significant new use to 
manufacture the substance with a maximum weight percentage of cobalt 
oxide impurity in excess of 2.1%. It is a significant new use to 
process or use the substance other than as an electrically conductive 
material, a heat dissipation material, a heat generation material, an 
additive for weight reduction, an additive to improve physical or 
mechanical properties, an additive in batteries, energy storage, and 
electrode applications, or an additive in field emission applications. 
It is a significant new use to process or use the substance in 
application methods that do not generate a vapor, mist, dust, or 
aerosol unless such an application method occurs in an enclosed 
process.
    (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

[[Page 65563]]

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.  721.11761   Multi-walled carbon nanotubes; closed; 17.0-34.7 nm 
diameter; globular shape; Grade: Jenotube 20.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as multi-walled carbon 
nanotubes; closed; 17.0-34.7 nm diameter; globular shape; Grade: 
Jenotube 20 (PMN P-20-65) 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 or 
incorporated into an article.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(3), (5), (6)(vii), (7), (8), and (c). For purposes of Sec.  
721.63(a)(5), respirators must provide a National Institute for 
Occupational Safety and Health (NIOSH) assigned protection factor (APF) 
of at least 50.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1), (3)(iii), and (5). For purposes of 
Sec.  721.72(g)(1), this substance may cause: skin sensitization; eye 
irritation; respiratory 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(f). It is a significant new use to 
manufacture the substance with a maximum weight percentage of cobalt 
oxide impurity in excess of 2.1%. It is a significant new use to 
process or use the substance other than as an electrically conductive 
material, a heat dissipation material, a heat generation material, an 
additive for weight reduction, an additive to improve physical or 
mechanical properties, an additive in batteries, energy storage, and 
electrode applications, or an additive in field emission applications. 
It is a significant new use to process or use the substance in 
application methods that do not generate a vapor, mist, dust, or 
aerosol unless such an application method occurs in an enclosed 
process.
    (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.  721.11762   Nonanamide, N,N-dimethyl.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as nonanamide, N,N-
dimethyl (PMN P-20-70; CAS No. 6225-08-7) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(3), (5), (6)(v), (vi), (7), (8), (b), and (c). For purposes 
of Sec.  721.63(b), the concentration is set at 1.0%. 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 (f), (g)(1), (3)(iii), 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; reproductive toxicity; 
aspiration hazard. Alternative hazard and warning statements that meet 
the criteria of the Globally Harmonized System and OSHA Hazard 
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. It is a 
significant new use to use the substance other than as a solvent for 
use in formulated pesticide products. It is a significant new use to 
manufacture the substance other than by import into the United States 
(i.e., no domestic manufacture) using 20,000 kg International 
Organization for Standardization tank containers (ISOtainers) or 1,000 
kg intermediate bulk containers (IBCs).
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N = 96.
    (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.  721.11763   2-Propenoic acid, 2-methyl, 2-(dimethylamino)ethyl 
ester, polymers with 2-(C16-18-acylamino)ethyl acrylate and 
hydroxyalkyl acrylate, acetates (salts) (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 2-
propenoic acid, 2-methyl, 2-(dimethylamino)ethyl ester, polymers with 
2-(C16-18-acylamino)ethyl acrylate and hydroxyalkyl acrylate, acetates 
(salts) (PMN P-20-84) 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) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(3) and (7), (b), and (c). For purposes of Sec.  721.63(b), 
the concentration is set at 1.0%.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), (g)(1), and (5). For purposes of Sec.  
721.72(e), the concentration is set at 1.0%. For purposes of Sec.  
721.72(g)(1), this substance may cause: skin irritation; eye 
irritation; 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 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.

[[Page 65564]]

Sec.  721.11764   4H-Pyran-4-one, 3-[(2,5-dihydro-4-methyl-5-oxo-2-
furanyl)oxy]-2-methyl.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 4H-pyran-4-one, 3-
[(2,5-dihydro-4-methyl-5-oxo-2-furanyl)oxy]-2-methyl (PMN P-20-105; CAS 
No. 1333341-34-6) 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)(3), (5), (6)(vii), (7), (8), (b), and (c). 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), (3)(iii), 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; 
reproductive toxicity; skin irritation; eye irritation. Alternative 
hazard and warning statements that meet the criteria of the Globally 
Harmonized System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f) and (o). It is a significant new use to 
process the substance other than in a facility that employs an on-site 
sump system used to capture fugitive dust releases and disposes the 
solid waste captured by this sump system by landfill. It is a 
significant new use to process the substance except under negative 
pressure when transferring the substance as a solid material in order 
to minimize exposures to fugitive dust/particles. It is a significant 
new use to use the substance in spray applications at a concentration 
exceeding 0.01% in formulation. It is a significant new use to use the 
substance other than to promote microbial activity in the soil, 
resulting in increases availability of nutrients in the soil, including 
nitrogen and phosphorus, for crops (for use on commercial farming 
operations).
    (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.  721.11765   2H-Pyran, tetrahydro-4-methyl.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 2H-pyran, 
tetrahydro-4-methyl (PMN P-20-127; CAS No. 4717-96-8) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(3), (5), (6)(v), (vi), (7), (8), (b), and (c). 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), (3)(iii), 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 corrosion; serious eye 
damage; specific target organ toxicity; aspiration hazard. Alternative 
hazard and warning statements that meet the criteria of the Globally 
Harmonized System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o).
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N=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 (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.  721.11766   Organic acid ester, polymer with aliphatic diols and 
1,1'-methylenebis[4-isocyanatobenzene] (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as organic 
acid ester, polymer with aliphatic diols and 1,1'-methylenebis[4-
isocyanatobenzene] (PMN P-20-130) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section. The requirements of this section do not apply to 
quantities of the substance after they have been completely reacted 
(cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(3), (5), (6)(ix), (7), (8), and (c). 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), and (5). For purposes of Sec.  
721.72(g)(1), this substance may cause: acute toxicity; skin 
irritation; respiratory sensitization; skin sensitization; genetic 
toxicity; carcinogenicity; 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 use. Requirements as 
specified in Sec.  721.80(o). It is a significant new use to use the 
substance in any manner or method that involves spray application.
    (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.  721.11767   4,4-Methylenebis (2,6-dimethyl phenol) polymer with 
2-(chloromethyl)oxirane, 1,4-benzene diol, 2-methyl-2-propenoic acid, 
mixed alkyl substituted 2-methyl 2-propenoate, and ethyl 2-propenoate, 
reaction products with 2-(dimethylamino) ethanol (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 4,4-
methylenebis (2,6-dimethyl phenol) polymer with 2-
(chloromethyl)oxirane, 1,4-benzene diol, 2-methyl-2-propenoic acid, 
mixed alkyl substituted 2-methyl 2-propenoate,

[[Page 65565]]

and ethyl 2-propenoate, reaction products with 2-(dimethylamino) 
ethanol (PMN P-21-3) 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 (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(3), (5), (6)(vii), (7), (8), (b), and (c). For purposes of 
Sec.  721.63(a)(5), respirators must provide a National Institute for 
Occupational Safety and Health (NIOSH) assigned protection factor (APF) 
of at least 10. For purposes of Sec.  721.63(b), the concentration is 
set at 1.0%.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), (g)(1), and (5). For purposes of Sec.  
721.72(g)(1), this substance may cause: skin irritation; eye 
irritation. 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.
    (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.  721.11768   Phenol, methylethylidene, polymer chloromethyl 
epoxide and methylethylidene bis-oxy, bis-amine (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as phenol, 
methylethylidene, polymer chloromethyl epoxide and methylethylidene 
bis-oxy, bis-amine (PMN P-21-28) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section. The requirements of this section do not apply to 
quantities of the substance after they have been completely reacted.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(3), (5), (6)(vii), (7), (8), and (c). 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 in non-spray applications and 1,000 in spray 
applications.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f) (g)(1), (3)(iii), 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; 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) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N = 100.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (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.  721.11769   Amine, methylethylidene bis(oxy) (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as amine, 
methylethylidene bis(oxy) (generic) (PMN P-21-29) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section. The requirements of this section do 
not apply to quantities of the substance after they have been 
completely reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(3), (5), (6)(vii), (7), (8), and (c). 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 in non-spray applications and 1,000 in spray 
applications.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f) (g)(1), (3)(iii), 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; 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) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N = 840.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (h), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11770   Carbamic acid, N-[3-(trialkoxysilyl)propyl]-, C,C'-
[2,2,4(or 2,4,4)-trimethyl-1,6-hexanediyl] ester (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
carbamic acid, N-[3-(trialkoxysilyl)propyl]-, C,C'-[2,2,4(or 2,4,4)-
trimethyl-1,6-hexanediyl] ester (PMN P-21-34) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section. The requirements of this section do not apply 
to quantities of the substance after they have been completely reacted 
(cured).
    (2) The significant new uses are:
    (i) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), (g)(1), (3)(iii), 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) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N = 1.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (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.

[[Page 65566]]

Sec.  721.11771   Arylfurandione, [bis(trihaloalkyl)alkylidene]bis-, 
polymer with alkanediamine (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
arylfurandione, [bis(trihaloalkyl)alkylidene]bis-, polymer with 
alkanediamine (PMN P-21-67) 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, or formed 
into an article.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(3) and (7), (b), and (c). For purposes of Sec.  721.63(b), 
the concentration is set at 1.0%.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), (g)(1), and (5). For purposes of Sec.  
721.72(e), the concentration is set at 1.0%. For purposes of Sec.  
721.72(g)(1), this substance may cause: skin irritation; eye 
irritation; specific target organ toxicity. Alternative hazard and 
warning statements that meet the criteria of the Globally Harmonized 
System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. It is a 
significant new use to manufacture or process the substance unless at a 
particle size of 10 microns or greater.
    (iv) Disposal. It is a significant new use to dispose of the 
substance or waste streams containing the substance by incineration 
unless such incineration occurs at a minimum temperature of 870 degrees 
Celsius.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (j) are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11772   Phosphonic acid, dimethyl ester, reaction products 
with alkyl-alkyl-alkanediol and alkanediol (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
phosphonic acid, dimethyl ester, reaction products with alkyl-alkyl-
alkanediol and alkanediol (PMN P-21-93) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section. The requirements of this section do not apply to 
quantities of the substance after they have been completely reacted 
(cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(3) and (7), (b), and (c). For purposes of Sec.  721.63(b), 
the concentration is set at 1.0%.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), (g)(1), (3)(iii), 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 corrosion; serious eye 
damage; 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 manufacture, process, or use the substance in 
any manner that generates a dust, mist, particulate, or aerosol that 
results in inhalation exposure. It is a significant new use to use the 
substance in consumer products where the concentration of the substance 
equals or exceeds 3%.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N = 180.
    (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.  721.11773   Silane, halogenated (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as silane, 
halogenated (PMN P-21-94) is subject to reporting under this section 
for the significant new uses described in paragraph (a)(2) of this 
section. The requirements of this section do not apply to quantities of 
the substance after they have been completely reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(3), (5), (6)(vii), (7), (8), (b), and (c). For purposes of 
Sec.  721.63(b), the concentration is set at 1.0%. For purposes of 
Sec.  721.63(a)(5), respirators must provide a National Institute for 
Occupational Safety and Health (NIOSH) assigned protection factor (APF) 
of at least 1,000.
    (A) As an alternative to the respirator requirements in paragraph 
(a)(2)(i) of this section, a manufacture or processor may choose to 
follow the new chemical exposure limit (NCEL) provision listed in the 
TSCA Order for this substance. The NCEL is 0.05 mg/m\3\ as an 8-hour 
time weighted average. Persons who wish to pursue NCELs as an 
alternative to Sec.  721.63 respirator requirements may request to do 
so under Sec.  721.30. Persons whose Sec.  721.30 requests to use the 
NCELs approach are approved by EPA will be required to follow NCELs 
provisions comparable to those contained in the corresponding TSCA 
Order.
    (B) [Reserved]
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), (g)(1), (3)(iii), 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 corrosion; eye damage; 
specific target organ toxicity; pulmonary effects; developmental 
neurotoxicity. Alternative hazard and warning statements that meet the 
criteria of the Globally Harmonized System and OSHA Hazard 
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. It is a 
significant new use to use the substance other than as a deposition 
precursor for the manufacture of electronic components.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N = 3.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11774   Heteromonocycle, polymer, substituted aliphatic 
carbamate, [2-[(1-oxo-2-propen-1-yl)oxy]alkyl]ester (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified

[[Page 65567]]

generically as heteromonocycle, polymer, substituted aliphatic 
carbamate, [2-[(1-oxo-2-propen-1-yl)oxy]alkyl]ester (PMN P-21-115) 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)(3), (5), (6)(vii), (7), (8), and (c). 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 of at least 1,000 during spray applications.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1), and (5). For purposes of Sec.  
721.72(g)(1), this substance may cause: skin irritation; eye 
irritation; skin sensitization; respiratory sensitization. Alternative 
hazard and warning statements that meet the criteria of the Globally 
Harmonized System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o).
    (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.  721.11775   Alkanes, C4-8-branched and linear.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as alkanes, C4-8-
branched and linear (PMN P-21-141; CAS No. 2529890-37-5) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(3) and (7), (b), and (c). For purposes of Sec.  721.63(b), 
the concentration is set at 0.1%.
    (ii) Industrial, commercial, and consumer activities. It is a 
significant new use to manufacture, process, or use the substance other 
than for use as a transportation fuel, refinery feedstock, or fuel 
blending additive.
    (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.  721.11776   5H-1,2-Oxathiole, 2,2-dioxide.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 5H-1,2-Oxathiole, 
2,2-dioxide (PMN P-21-196; CAS No. 21806-61-1) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section. The requirements of this section do not apply 
to quantities of the substance after they have been incorporated into 
an article.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(3), (5), (6)(v) (vi), (7), (8), (b), and (c). For purposes of 
Sec.  721.63(a)(5), respirators must provide a National Institute for 
Occupational Safety and Health (NIOSH) assigned protection factor (APF) 
of at least 1000. For purposes of Sec.  721.63(b), the concentration is 
set at 0.1%.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1), (3)(iii), and (5). For purposes of 
Sec.  721.72(g)(1), this substance may cause: carcinogenicity, 
reproductive toxicity, skin sensitization; respiratory 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). It is a significant new use to process 
or use the substance other than an enclosed system unless the worker 
personal protective equipment described in paragraph (a)(2)(i) of this 
section is used.
    (iv) Disposal. Requirements as specified in Sec.  721.85(b)(1) and 
(2), and (c)(1) and (2). It is a significant new use to dispose of the 
substance by incineration unless the removal efficiency is at least 
99.9%.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (j) are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
* * * * *
[FR Doc. 2022-23376 Filed 10-28-22; 8:45 am]
BILLING CODE 6560-50-P


