[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]
[[Page 65548]]
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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