[Federal Register Volume 86, Number 224 (Wednesday, November 24, 2021)]
[Proposed Rules]
[Pages 66993-67012]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-24790]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2021-0030; FRL-8805-01-OCSPP]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances (21-
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 December 27, 2021.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2021-0030, 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)
[[Page 66994]]
or other information whose disclosure is restricted by statute.
Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is closed to visitors with
limited exceptions. The staff continues to provide remote customer
service via email, phone, and webform. For the latest status
information on EPA/DC services and docket access, visit 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 December 27, 2021
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-2021-0030, 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
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
[[Page 66995]]
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. 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.
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 Order.
Potentially Useful Information.
CFR citation assigned in the regulatory text section of
the proposed rule.
The chemicals subject to these proposed SNURs are as follows:
PMN Numbers: P-09-477 and P-09-485.
Chemical Names: 1-Butanesulfonamide, 1,1,2,2,3,3,4,4,4-nonafluoro-
(P-09-477) and 1-butanesulfonamide, 1,1,2,2,3,3,4,4,4-nonafluoro-N,N-
bis(2-hydroxyethyl)- (P-09-485).
CAS Numbers: 30334-69-1 (P-09-477) and 34455-00-0 (P-09-485).
Effective Date of TSCA Order: November 5, 2009.
Basis for TSCA Order: The PMNs state that the generic (non-
confidential) use of the substances will be as fluorinated
intermediates. EPA identified concerns for the potential degradation
products of the PMN substances. Based on their physical/chemical and
environmental fate properties, these degradation products
arepotentially persistent, bioaccumulative, and toxic (PBT) chemicals
(as described in the New Chemical Program's PBT category at 64 FR
60194; November 1999). EPA estimates that the degradation products of
the PMN substances will persist in the environment for more than 6
months and estimates a bioaccumulation factor of greater than or equal
to 1,000. Based on the physical/chemical properties of the PMN
substances and comparison to analogous chemical substances, EPA
hasidentified concerns for lung, blood, and spleen effects for P-09-477
and lung surfactancy, eye irritation, skin irritation, irritation to
mucous membranes, and lung irritation for P-09-485. Based on available
data on analogs of the potential degradation products of the PMN
substances, EPA has identified concerns for liver, blood, and kidney
toxicity, developmental toxicity, and immunotoxicity. Based on
comparison to analogous chemical substances and available data on
analogs of the potential degradation products, EPA has also identified
concerns for aquatic toxicity.
In 2009, EPA issued an Order for P-09-477 and P-09-485 under TSCA
sections 5(e)(1)(A)(i), 5(e)(1)(A)(ii)(I), and 5(e)(1)(A)(ii)(II),
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 and that
the substances will be produced in substantial quantities and may be
anticipated to enter the environment in substantial quantities and
there may be significant (or substantial) exposures to the substances.
The Order requires protective measures to limit exposures or otherwise
mitigate the potential unreasonable risk. Specifically, the Order
prohibits the PMN submitter from any predictable or purposeful release
of the PMN substances or any waste stream from manufacturing,
processing, and use containing the PMN substances into the waters of
the United States.
The protective measures in the Order only apply to the PMN
submitter who is subject to the Order. One of the purposes of a SNUR is
to extend protective measures to other manufacturers and processors.
EPA did not issue SNURs following the Order in 2009 to apply to other
manufacturers and processors. EPA is now proposing these SNURs to limit
environmental releases for all other manufacturers and processors. EPA
is proposing to designate as a significant new use any release to water
of waste streams from manufacture, processing, or use containing the
substances.
As further discussed in Unit VI., EPA must determine that a use of
a chemical substance is not ongoing in order to designate that use as a
significant new use. EPA has received no information (e.g.,
notification under the Chemical Data Reporting rule, TSCA notices,
other required reporting) which indicates that any person other than
the PMN submitter is engaged in the manufacture or processing of these
substances. Because the PMN submitter is subject to the terms of the
Order and no other manufacturers or processors have been identified,
EPA concludes that the significant new use is not ongoing.
EPA recognizes that manufacturers and processors that would be
subject to the proposed SNURs could request under Sec. 721.30 to
employ alternative measures to control environmental release of these
substances as described in a compliance monitoring plan that provides
substantially the same degree of protection as the existing consent
order. EPA has identified the following information that at a minimum
would be useful to address the requirements of Sec. 721.30(b)(4), (5),
and (6):
Description of the pretreatment process and any treatment
technologies employed;
Description of the analytical method used (and the non-
detect limit of method);
Sampling locations, frequency, QA/QC for handling and
transport;
Monitoring location, frequency, and QA/QC if non-detect
limit exceeded; and
Copy of the facility's National Pollutant Discharge
Elimination System
[[Page 66996]]
(NPDES) permit(s), and identification of any discharge limits
EPA will review this and other relevant information when making an
equivalency determination under Sec. 721.30; however, submission of
this information does not guarantee approval of the request.
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
physical/chemical properties, environmental fate, aquatic toxicity,
reproductive/developmental toxicity, and specific target organ 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.
CFR Citation: 40 CFR 721.11635 (P-09-477) and 40 CFR 721.11636 (P-
09-485).
PMN Number: P-18-65
Chemical Name: 1,3-Propanediamine, N1,N1-dimethyl-N3-(2,2,6,6-
tetramethyl-4-piperidinyl)-.
CAS Number: 78014-16-1.
Effective Date of TSCA Order: October 7, 2020.
Basis for TSCA Order: The PMN states that the use of the substance
will be as an absorption agent and lab reagent. Based on submitted test
data on the PMN substance, EPA has identified concerns for irritation/
corrosion to the eyes, skin, and respiratory tract, acute oral
toxicity, and aspiration hazard. Based on a structural alert for
nitrogen heterocycles, EPA has also identified concerns for systemic
and developmental toxicity. Based on comparison to analogous aliphatic
amines, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 431 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. The Order was also 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 expected to be produced in substantial
quantities, and that there may be significant or substantial human
exposure to the substance, or that the substance may enter the
environment in substantial quantities. To protect against these risks,
the Order requires:
Use of the PMN substance only as an absorption agent or
laboratory reagent;
Unloading of the PMN substance only under a gas (e.g.,
nitrogen) blanket;
No domestic manufacture of the PMN substance (i.e., import
only);
Processing of the PMN substance only as described in the
PMN or with additional steps that would reduce air emission; and
No release of the PMN substance into the waters of the
United States.
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
reproductive toxicity, developmental effects, and specific target organ
toxicity 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.
CFR Citation: 40 CFR 721.11637.
PMN Number: P-18-303
Chemical Name: 2-Propenoic acid, polymer with aliphatic cyclic
epoxide (generic).
CAS Number: Not available.
Effective Date of TSCA Order: July 30, 2020.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the substance will be as an ultraviolet (UV)
curable oligomer. Based on comparison to analogous 2-ethylhexyl
acrylates and structural alerts for acrylates, EPA has identified
concerns for eye, skin, and respiratory tract irritation. Based on data
for acrylic acid, EPA has identified concerns for corrosion to the eye
and skin. Based on comparison to analogous acrylates/methacrylates, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 2 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 to human health or the
environment. To protect against these risks, the Order requires:
No release of the PMN substance into the waters of the
United States.
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.
CFR Citation: 40 CFR 721.11638.
PMN Number: P-18-345
Chemical Name: 1-Butanone, 2-(dimethylamino)-1-[4-(2-ethyl-2-
methyl-3-oxazolidinyl)phenyl]-2-(phenylmethyl)-.
CAS Number: 2230995-63-6.
Effective Date of TSCA Order: February 2, 2021.
Basis for TSCA Order: The PMN states that the use of the substance
will be as a UV curing agent in highly pigmented inks, photo-resists,
and masks. Based on the physical/chemical properties of the PMN
substance and test data on structurally similar substances, the PMN
substance is a potentially persistent, bioaccumulative, and toxic (PBT)
chemical, as described in EPA's Policy Statement on PBT New Chemical
Substances in the Federal Register of November 4, 1999 (64 FR 60194)
(FRL-6097-7). EPA estimates that the PMN substance will persist in the
environment for more than 2 months and estimates a bioaccumulation
factor of greater than or equal to 1,000. Based on comparison to
structurally analogous chemical substances, EPA has identified concerns
for reproductive and developmental effects, eye irritation, and dermal
sensitization. Based on comparison to analogous aliphatic amines, EPA
predicts 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
and the
[[Page 66997]]
environment. To protect against these risks, the Order requires:
No release of the PMN substance to the waters of the
United States.
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
physical/chemical properties, environmental fate, aquatic toxicity, and
reproductive 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 a
submission of this or other relevant information.
CFR Citation: 40 CFR 721.11639.
PMN Number: P-18-351
Chemical Name: Acrylic acid, tricyclo alkyl ester (generic).
CAS Number: Not available.
Effective Date of TSCA Order: February 23, 2021.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the substance will be in UV curable inks. Based on
Michael addition of the acrylate group, EPA has identified concerns for
skin irritation and dermal sensitization. Based on the comparison to
structurally analogous chemical substances, EPA has also identified
concerns for reproductive, developmental, and systemic toxicity. Based
on comparison to analogous acrylates/methacrylates and submitted test
data on the new chemical substance, EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 13 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 National Institute for Occupational Safety and
Health (NIOSH)-certified gas/vapor respirator with an assigned
protection factor (APF) of at least 50 where there is a potential for
inhalation exposure;
Use of the PMN substance only for the confidential uses
allowed in the Order;
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the safety
data sheet (SDS); and
No release of the PMN substance resulting in surface water
concentrations that exceed 13 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 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, reproductive/developmental toxicity,
and chronic 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.
CFR Citation: 40 CFR 721.11640.
PMN Number: P-19-48
Chemical Name: Poly(oxy-1,2-ethanediyl), .alpha.-hydro-.omega.-
hydroxy-, mono-C12-14-alkyl ethers, phosphates, sodium salts.
CAS Number: 1548592-90-0.
Effective Date of TSCA Order: September 24, 2020.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a coating additive. Based on comparison to
analogous chemical substance, EPA has identified concerns for lung
effects. Based on test data on the PMN substance and information in the
SDS, EPA has also identified concerns for skin irritation. Based on
comparison to analogous anionic surfactants, EPA predicts 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:
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 10 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 to 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
pulmonary effects and acute and chronic 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.
CFR Citation: 40 CFR 721.11641.
PMN Number: P-20-26
Chemical Name: N-alkyl heteromonocyclic diphenolamide (generic).
CAS Number: Not available.
Effective Date of TSCA Order: September 30, 2020.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a coating additive. Based on comparison to
analogous chemical substance, EPA has identified concerns for lung
effects. Based on test data on the PMN substance and information in the
SDS, EPA has also identified concerns for skin irritation. Based on
comparison to analogous anionic surfactants, EPA predicts 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:
Use of personal protective equipment where there is a
potential for dermal exposure;
[[Page 66998]]
Use of a NIOSH-certified respirator with an APF of at
least 10 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 to 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
pulmonary effects and acute and chronic 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.
CFR Citation: 40 CFR 721.11641.
PMN Number: P-20-26
Chemical Name: N-alkyl heteromonocyclic diphenolamide (generic).
CAS Number: Not available.
Effective Date of TSCA Order: September 30, 2020.
Basis for TSCA Order: The PMN states that the use of the substance
will be as a monomer that is isolated and used for subsequent
polymerization. Based on comparison to structurally analogous chemical
substances, EPA has identified concerns for systemic effects,
reproductive toxicity, developmental toxicity, and irritation/corrosion
to the skin, eyes, and respiratory tract. Based on comparison to
analogous chemical substances, EPA has determined that toxicity to
aquatic organisms may occur at concentrations that exceed 41 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 10,000 where there is a potential for inhalation exposure;
No use of the PMN substance other than as a chemical
intermediate;
No exceedance of the confidential annual production volume
listed in the Order;
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 41 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 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, reproductive toxicity, developmental
effects, skin irritation, skin corrosion, eye damage, and aquatic
toxicity 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.
CFR Citation: 40 CFR 721.11642.
PMN Number: P-20-46
Chemical Name: Reaction products of alkyl-terminated
alkylalumuminoxanes and [[(pentaalkylphenyl-
(pentaalkylphenyl)amino)alkyl]alkanediaminato]bis(aralkyl) transition
metal coordination compound (generic).
CAS Number: Not available.
Effective Date of TSCA Order: October 30, 2020.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the substance will be as a catalyst. Based on the
physical/chemical and environmental fate properties of the ligand, the
ligand is a potentially persistent, bioaccumulative, and toxic (PBT)
chemical, as described in EPA's Policy Statement on PBT New Chemical
Substances in the Federal Register of November 4, 1999 (64 FR 60194)
(FRL-6097-7). EPA estimates that the ligand will persist in the
environment for more than 2 months and estimates a bioconcentration
factor of greater than or equal to 5,000. Based on physical/chemical
properties, structural information and comparison to structurally
analogous chemical substances, EPA has identified concerns for lung
effects (if respirable, poorly soluble particulates are inhaled),
corrosion to the skin, eyes, and respiratory tract, irritation,
potential lung toxicity, and carcinogenicity. EPA has also identified
concerns for systemic effects and reproductive/developmental effects to
the extent the metal components are bioavailable and to the extent the
PMN substance is able to chelate nutrient metals. Based on available
toxicity data on a residual, EPA has also identified concerns for
neurotoxicity and kidney toxicity. Based on the comparison to analogous
aluminum compounds, EPA predicts toxicity to aquatic organisms may
occur at concentrations that exceed 28 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
other than in an enclosed process as defined in the Order;
Disposal of the PMN substance and any waste streams from
processing and use containing the PMN substance by incineration only;
No release of the PMN substance directly to air;
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 to 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
physical/chemical, environmental fate, specific target organ toxicity,
skin corrosion, skin irritation, eye damage, 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
[[Page 66999]]
Order is modified or revoked by EPA based on submission of this or
other relevant information.
CFR Citation: 40 CFR 721.11643.
PMN Number: P-20-72
Chemical Name: Multi-walled carbon nanotubes (generic).
CAS Number: Not available.
Effective Date of TSCA Order: September 29, 2020.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the substance will be as an additive used to
impart specific physiochemical properties to finished articles. Based
on available data for other multi-walled carbon nanotubes and by
analogy to asbestos, EPA has identified concerns for lung effects (lung
overload and lung carcinogenicity) if respirable, poorly soluble
particulates and fibers are inhaled. Based on comparison to
structurally analogous chemical substances, EPA has also identified
concerns for eye irritation and systemic effects. Based on the presence
of a confidential residual, EPA has also identified concerns for acute
neurotoxicity, dermal and respiratory sensitization, mutagenicity, and
carcinogenicity. 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 N-
100, P-100, or R-100 cartridges with an APF of at least 50 where there
is a potential for inhalation exposure;
No domestic manufacture of the PMN substance (i.e., import
only);
No exceedance of the confidential annual importation
volume listed in the Order;
No importation of the PMN substance other than as
confidentially described in the PMN and allowed in the Order;
No importation of the PMN substance such that the maximum
weight percentage of the confidential impurity exceeds the confidential
percentage identified in the Order;
No processing or use of the PMN substance other than for
the confidential use allowed in the Order;
Disposal of the PMN substance and any waste streams from
processing and use containing the PMN substance by incineration or
landfill only;
No release of the PMN substance directly to air;
No processing or use of the PMN substance in application
methods that generate a dust, mist, spray, vapor, or aerosol unless
such application method occurs in an enclosed process;
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 to 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, pulmonary effects, eye irritation,
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.
CFR Citation: 40 CFR 721.11644.
PMN Number: P-20-120
Chemical Name: Carbomonocyclic sulfonium, salt with trihalo-
sulfoalkyl hydroxycarbopolycyclic carboxylate (generic).
CAS Number: Not available.
Effective Date of TSCA Order: November 3, 2020.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the PMN substance will be as an ingredient used in
the manufacture of photoresist. Based on the physical/chemical
properties of the PMN substance and test data on structurally similar
substances, the PMN substance is a potentially persistent,
bioaccumulative, and toxic (PBT) chemical, as described in EPA's Policy
Statement on PBT New Chemical Substances in the Federal Register of
November 4, 1999 (64 FR 60194) (FRL-6097-7). EPA estimates that the PMN
substance will persist in the environment for more than 2 months and
estimates a bioaccumulation factor of greater than or equal to 1,000.
Based on the photoreactivity of the PMN substance, EPA has identified
concerns for photosensitization. Based on comparison to analogous
substances, EPA has identified concerns for eye corrosion, irritation,
acute toxicity, liver toxicity, and neurotoxicity. Based on positive
mutagenicity test results for analogous chemical substances and
available data on an analog of the confidential anion analogue, EPA has
identified concerns for reproductive (developmental) toxicity. EPA has
also identified concerns for lung overload by insoluble polymers for
photoacid generators with polymeric anions that have a molecular weight
over 10,000 g/mol. EPA was unable to estimate the environmental hazard
of 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:
No manufacture of the PMN substance beyond the time limits
specified in the Order without submittal to EPA of the results of
certain testing described in the Testing section of the Order;
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 modification of the processing or use of the PMN
substance in any way that generates a vapor, dust, mist, or aerosol in
a non-enclosed process;
Use of the PMN substance only for the confidential use
allowed in the Order;
No domestic manufacture of the PMN substance (i.e., import
only);
Import of the PMN substance only in solution, or in any
form in sealed containers weighing 5 kilograms or less; and
No exceedance of the confidential annual importation
volume listed the Order.
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 about the physical/chemical properties, fate,
bioaccumulation, environmental hazard, and human health effects of the
PMN substance 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. The submitter has agreed not to exceed the
time limits
[[Page 67000]]
specified in the Order without performing the required Tier I and Tier
II testing outlined in the Testing section of the Order.
CFR Citation: 40 CFR 721.11645.
PMN Numbers: P-20-122, P-20-139, P-20-140, P-20-141, P-20-142, P-20-
145, P-20-147, P-20-152, P-20-155, and P-20-159
Chemical Names: Heterocyclic onium compound with 1-substituted-
alkyl 2,2,2-trisubstitutedalkyl 2-methyl-2-propenoate (1:1), polymer
with acenaphthylene, 4-ethenyl-a,a-dimethylbenzenemethanol and 4-
ethenylphenyl acetate, hydrolyzed (generic) (P-20-122), Sulfonium,
triphenyl-, 1,2-substituted-alkyltricycloalkyl-1-carboxylate (1:1)
(generic) (P-20-139), N-substituted-beta-alanine, heterosubstituted-
alkyl ester, ion(1-), triphenylsulfonium (1:1) (generic) (P-20-140),
Sulfonium, [4-(1,1-dimethylethyl)phenyl]diphenyl-, salt with
heterosubstituted-alkyl tricycloalkane-carboxylate (1:1) (generic) (P-
20-141), Dibenzothiophenium, 5-phenyl-, salt with 2,2-
diheterosubstituted-2-sulfoethyl substituted-heterotricycloalkane-
carboxylate (1:1) (generic) (P-20-142), Substituted heterocyclic onium
compound, salt with heteropolysubstitutedalkyl
substitutedtricycloalkanecarboxylate (1:1), polymer with disubstituted
aromatic compound and 1-methylcyclopentyl 2-methyl-2-propenoate, di-Me
2,2'-(1,2-diazenediyl)bis[2-methylpropenoate]-initiated (generic) (P-
20-145), Substituted-2H-thiopyrylium, salt with heterosubstituted-alkyl
tricycloalkane-carboxylate (1:1) (generic) (P-20-147), Sulfonium,
triphenyl-, salt with 2,2-dihalo-2-sulfoethyl-2-oxo substituted-
heterotricycloalkane-heteropolycyclo-carboxylate (1:1) (generic) (P-20-
152), Sulfonium, triphenyl-, salt with 5-alkyl-2-alkyl-4-(2,4,6-
substituted tri-carbomonocycle, hetero-acid) benzenesulfonate (1:1)
(generic) (P-20-155), and Phenoxanthiinium, 10-phenyl, 5-alkyl-2-alkyl-
4-(2,4,6-substituted tri-carbomonocycle, hetero-acid) benzenesulfonate
(1:1) (generic) (P-20-159).
CAS Numbers: Not available.
Effective Date of TSCA Order: October 28, 2020.
Basis for TSCA Order: PMN P-20-140 states that the use of the PMN
substance will as a photoacid generator for chemically amplified
photoresist. PMNs P-20-122, P-20-139, P-20-141, P-20-142, P-20-145, P-
20-147, P-20-152, P-20-155, and P-20-159 state that the generic (non-
confidential) use of the PMN substances will be a contained use for
microlithography for electronic device manufacturing. Based on the
physical/chemical properties of the PMN substances and test data on
structurally similar substances, the PMN substances are potentially
persistent, bioaccumulative, and toxic (PBT) chemicals, as described in
EPA's Policy Statement on PBT New Chemical Substances in the Federal
Register of November 4, 1999 (64 FR 60194) (FRL-6097-7). EPA estimates
that the PMN substances will persist in the environment for more than 2
months and estimates a bioaccumulation factor of greater than or equal
to 1,000. Based on photoreactivity, EPA has identified concerns for
photosensitization. Based on comparison to structurally analogous
chemical substances, EPA has also identified concerns for eye
corrosion, irritation, acute toxicity, liver toxicity, and
neurotoxicity. Based on positive mutagenicity test results for
analogous chemical substances and available data on an analog of the
confidential anion, EPA has identified concerns for reproductive
(developmental) toxicity. EPA was unable to estimate the environmental
hazard of the PMN 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 manufacture of the PMN substances beyond the time
limits specified in the Order without submittal to EPA of the results
of certain testing described in the Testing section of the Order;
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 modification of the processing of the PMN substances in
any way that generates a vapor, dust, mist, or aerosol in a non-
enclosed process;
Use of the PMN substances only for the confidential uses
allowed in the Order. For P-20-140 use only as a photoacid generator
for chemically amplified photoresist;
No domestic manufacture of the PMN substances (i.e.,
import only);
Import of the PMN substance only in solution, or in any
form in sealed containers weighing 5 kilograms or less; and
No exceedance of the confidential annual importation
volumes listed the Order.
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 about the physical/chemical properties, fate,
bioaccumulation, environmental hazard, and human health effects of the
PMN substances 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. The submitter has agreed not to exceed the
time limits specified in the Order without performing the required Tier
I and Tier II testing outlined in the Testing section of the Order.
CFR Citations: 40 CFR 721.11646 (P-20-122), 40 CFR 721.11647 (P-20-
139), 40 CFR 721.11648 (P-20-140), 40 CFR 721.11649 (P-20-141), 40 CFR
721.11650 (P-20-142), 40 CFR 721.11651 (P-20-145), 40 CFR 721.11652 (P-
20-147), 40 CFR 721.11653 (P-20-152), 40 CFR 721.11654 (P-20-155), and
40 CFR 721.11655 (P-20-159).
PMN Numbers: P-20-156 and P-20-162
Chemical Names: Substituted, triaryl-, tricycloalkane alkyl
disubstituted (generic) (P-20-156) and Sulfonium, triaryl-, 3,3,3-
trihalo-2-sulfoalkyl polycycloalkane-1-carboxylate (generic) (P-20-
162).
CAS Numbers: Not available.
Effective Date of TSCA Order: December 7, 2020.
Basis for TSCA Order: The PMNs state that the generic (non-
confidential) use of the PMN substances will be for photolithography.
Based on the physical/chemical properties of the PMN substances and
test data on structurally similar substances, the PMN substances are
potentially persistent, bioaccumulative, and toxic (PBT) chemicals, as
described in EPA's Policy Statement on PBT New Chemical Substances in
the Federal Register of November 4, 1999 (64 FR 60194) (FRL-6097-7).
EPA estimates that the PMN substances will persist in the environment
for more than 2 months and estimates a bioaccumulation factor of
greater than or equal to 1,000. Based on the photoreactivity of the PMN
substances, EPA has identified concerns for photosensitization. Based
on comparison to analogous substances, EPA has identified concerns for
eye corrosion, irritation, acute toxicity, liver toxicity, and
neurotoxicity. Based on
[[Page 67001]]
positive mutagenicity test results for analogous chemical substances
and available data on an analog of the confidential anion, EPA has
identified concerns for reproductive (developmental) toxicity. EPA has
also identified concerns for lung overload by insoluble polymers for
photoacid generators with polymeric anions that have a molecular weight
over 10,000 g/mol. 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 manufacture of the PMN substances beyond the time
limits specified in the Order without submittal to EPA of the results
of certain testing described in the Testing section of the Order;
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 modification of the processing or use of the PMN
substances in any way that generates a vapor, dust, mist, or aerosol in
a non-enclosed process;
Use of the PMN substances only for the confidential use
allowed in the Order;
No domestic manufacture of the PMN substances (i.e.,
import only);
Import of the PMN substances only in solution, or in any
form in sealed containers weighing 5 kilograms or less; and
No exceedance of the confidential annual importation
volumes listed the Order.
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 about the physical/chemical properties, fate,
bioaccumulation, environmental hazard, and human health effects of the
PMN substances 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. The submitter has agreed not to exceed the
time limits specified in the Order without performing the required Tier
I and Tier II testing outlined in the Testing section of the Order.
CFR Citations: 40 CFR 721.11656 (P-20-156) and 40 CFR 721.11657 (P-
20-162).
PMN Number: P-21-6
Chemical Name: Naphthalene derivative (generic).
CAS Number: Not available.
Effective Date of TSCA Order: January 14, 2021.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the substance will be for froth flotation to treat
rare earth minerals and to remove deleterious substances. Based on
comparison to structurally analogous chemical substances, EPA has
identified concerns for aquatic toxicity, mortality, neurotoxicity,
lung histopathology, reproductive/developmental toxicity, and
genotoxicity. Based on the test data for the hydrolysis product, EPA
has identified dermal irritation, ocular irritation, respiratory
irritation, acute toxicity, neurotoxicity, dermal sensitization, lung
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;
Use of a NIOSH-certified respirator with an APF of at
least 50 to prevent inhalation exposure 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;
Use of the PMN substance only for the confidential use
allowed in the Order;
No domestic manufacture (i.e., import only); and
No release of the PMN substance to 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 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.
CFR Citation: 40 CFR 721.11658.
V. 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 IV. 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.
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
[[Page 67002]]
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 it is highly
unlikely that any of the significant new uses described in the
regulatory text of this proposed rule are ongoing.
Therefore, EPA designates November 24, 2021 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 the above mentioned date, that person would have to
cease any such activity upon the effective date of the final rule. To
resume their activities, these persons would have to first comply with
all applicable SNUR notification requirements and wait until 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, TSCA Order, or consent agreement under
TSCA section 4 covering the chemical substance, persons are required
only to submit information in their possession or control and to
describe any other information known 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 IV. 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 IV.
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 IV. 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.
[[Page 67003]]
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 Order 12866: Regulatory Planning and Review and Executive
Order 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, 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 $16,000 to $2,800. This lower fee
reduces the total reporting and recordkeeping of cost of submitting a
SNUN to about $10,116 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 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. Accordingly, the requirements
of Executive Order 13175 (65 FR 67249, November 9, 2000), do not apply
to this action.
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 proposed rule is not expected to affect
energy supply, distribution, or use.
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 Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations
This action does not entail special considerations of environmental
justice related issues as delineated by Executive Order 12898 (59 FR
7629, February 16, 1994).
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
[[Page 67004]]
Dated: October 26, 2021.
Tala Henry,
Deputy Director, Office of Pollution Prevention and Toxics.
Therefore, for the reasons stated in the preamble, EPA proposes
that 40 CFR chapter I be amended as follows:
PARTS 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. 721.11635 through 721.11658 to subpart E to read as
follows:
Subpart E-Significant New Uses for Specific Chemical Substances
Sec.
* * * * *
721.11635 1-Butanesulfonamide, 1,1,2,2,3,3,4,4,4-nonafluoro-.
721.11636 1-Butanesulfonamide, 1,1,2,2,3,3,4,4,4-nonafluoro-N,N-
bis(2-hydroxyethyl)-.
721.11637 1,3-Propanediamine, N1,N1-dimethyl-N3-(2,2,6,6-
tetramethyl-4-piperidinyl)-.
721.11638 2-Propenoic acid, polymer with aliphatic cyclic epoxide
(generic).
721.11639 1-Butanone, 2-(dimethylamino)-1-[4-(2-ethyl-2-methyl-3-
oxazolidinyl)phenyl]-2-(phenylmethyl)-.
721.11640 Acrylic acid, tricyclo alkyl ester (generic).
721.11641 Poly(oxy-1,2-ethanediyl), .alpha.-hydro-.omega.-hydroxy-,
mono-C12-14-alkyl ethers, phosphates, sodium salts.
721.11642 N-alkyl heteromonocyclic diphenolamide (generic).
721.11643 Reaction products of alkyl-terminated alkylalumuminoxanes
and [[(pentaalkylphenyl-
(pentaalkylphenyl)amino)alkyl]alkanediaminato]bis(aralkyl)
transition metal coordination compound (generic).
721.11644 Multi-walled carbon nanotubes (generic).
721.11645 Carbomonocyclic sulfonium, salt with trihalo-sulfoalkyl
hydroxycarbopolycyclic carboxylate (generic).
721.11646 Heterocyclic onium compound with 1-substituted-alkyl
2,2,2-trisubstitutedalkyl 2-methyl-2-propenoate (1:1) polymer with
acenaphthylene, 4-ethenyl-a,a-dimethylbenzenemethanol and 4-
ethenylphenyl acetate, hydrolyzed (generic).
721.11647 Sulfonium, triphenyl-, 1,2-substituted-alkyltricycloalkyl-
1-carboxylate (1:1) (generic).
721.11648 N-substituted-beta-alanine, heterosubstituted-alkyl ester,
ion(1-), triphenyl sulfonium (1:1) (generic).
721.11649 Sulfonium, [4-(1,1-dimethylethyl)phenyl]diphenyl-, salt
with heterosubstituted-alkyl tricycloalkane-carboxylate (1:1)
(generic).
721.11650 Dibenzothiophenium, 5-phenyl-, salt with 2,2-
diheterosubstituted-2-sulfoethyl substituted-heterotricycloalkane-
carboxylate (1:1) (generic).
721.11651 Substituted heterocyclic onium compound, salt with
heteropolysubstitutedalkyl substitutedtricycloalkanecarboxylate
(1:1), polymer with disubstituted aromatic compound and 1-
methylcyclopentyl 2-methyl-2-propenoate, di-Me 2,2'-(1,2-
diazenediyl)bis[2-methylpropenoate]-initiated (generic).
721.11652 Substituted-2H-thiopyrylium, salt with heterosubstituted-
alkyl tricycloalkane-carboxylate (1:1) (generic).
721.11653 Sulfonium, triphenyl-, salt with 2,2-dihalo-2-sulfoethyl-
2-oxo substituted-heterotricycloalkane-heteropolycyclo-carboxylate
(1:1) (generic).
721.11654 Sulfonium, triphenyl-, salt with 5-alkyl-2-alkyl-4-(2,4,6-
substituted tri-carbomonocycle, hetero-acid) benzenesulfonate (1:1)
(generic).
721.11655 Phenoxanthiinium, 10-phenyl, 5-alkyl-2-alkyl-4-(2,4,6-
substituted tri-carbomonocycle, hetero-acid) benzenesulfonate (1:1)
(generic).
721.11656 Substituted, triaryl-, tricycloalkane alkyl disubstituted
(generic) (P-20-156).
721.11657 Substituted, triaryl-, tricycloalkane alkyl disubstituted
(generic) (P-20-162).
721.11658 Naphthalene derivative (generic).
* * * * *
Sec. 721.11635 1-Butanesulfonamide, 1,1,2,2,3,3,4,4,4-nonafluoro-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1-
butanesulfonamide, 1,1,2,2,3,3,4,4,4-nonafluoro- (PMN P-09-477; CAS No.
30334-69-1) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(ii) [Reserved]
(b) Specific requirements.The provisionsof 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 and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11636 1-Butanesulfonamide, 1,1,2,2,3,3,4,4,4-nonafluoro-N,N-
bis(2-hydroxyethyl)-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1-
butanesulfonamide, 1,1,2,2,3,3,4,4,4-nonafluoro-N,N-bis(2-
hydroxyethyl)- (PMN P-09-485; CAS No. 34455-00-0) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1)
(ii) [Reserved]
(b) Specific requirements.The provisionsof 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 and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11637 1,3-Propanediamine, N1,N1-dimethyl-N3-(2,2,6,6-
tetramethyl-4-piperidinyl)-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1,3-propanediamine,
N1,N1-dimethyl-N3-(2,2,6,6-tetramethyl-4-piperidinyl)- (PMN P-18-65;
CAS No. 78014-16-1) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f). It is a significant new use to use the
substance other than as an absorption agent or as a laboratory reagent.
It is a significant new use to unload the substance other than under a
gas (e.g., nitrogen) blanket. It is a significant new use to process
the substance other than as described in the PMN or without additional
steps that would reduce air emissions.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i), and (k) are applicable to manufacturers
and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The
[[Page 67005]]
provisions of Sec. 721.185 apply to this section.
Sec. 721.11638 2-Propenoic acid, polymer with aliphatic cyclic
epoxide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as 2-
propenoic acid, polymer with aliphatic cyclic epoxide (PMN P-18-303) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the substance after they have
been completely reacted or cured.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(ii) [Reserved]
(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 and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11639 1-Butanone, 2-(dimethylamino)-1-[4-(2-ethyl-2-methyl-
3-oxazolidinyl)phenyl]-2-(phenylmethyl)-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1-butanone, 2-
(dimethylamino)-1-[4-(2-ethyl-2-methyl-3-oxazolidinyl)phenyl]-2-
(phenylmethyl)- (PMN P-18-345; CAS No. 2230995-63-6) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section. The requirements of this section do
not apply to quantities of the substance after they have been
completely reacted or cured.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(ii) [Reserved]
(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 and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11640 Acrylic acid, tricyclo alkyl ester (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as acrylic
acid, tricyclo alkyl ester (PMN P-18-351) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section. The requirements of this section do not apply to
quantities of the substance after they have been completely reacted or
cured.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3) through (5), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) and (a)(4), engineering control measures (e.g., enclosure
or confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. For purposes of Sec. 721.63(a)(5), respirators must
provide a National Institute for Occupational Safety and Health (NIOSH)
assigned protection factor (APF) of at least 50.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), and (g)(5). For purposes of Sec.
721.72(g)(1), this substance may cause: Skin irritation; 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(k).
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=13.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.
Sec. 721.11641 Poly(oxy-1,2-ethanediyl), .alpha.-hydro-.omega.-
hydroxy-, mono-C12-14-alkyl ethers, phosphates, sodium salts.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as poly(oxy-1,2-
ethanediyl), .alpha.-hydro-.omega.-hydroxy-, mono-C12-14-alkyl ethers,
phosphates, sodium salts (PMN P-19-48; CAS No. 1548592-90-0) is subject
to reporting under this section for the significant new uses described
in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3) through (5), (b), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) and (a)(4), engineering control measures (e.g., enclosure
or confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. For purposes of Sec. 721.63(a)(5), respirators must
provide a National Institute for Occupational Safety and Health (NIOSH)
assigned protection factor (APF) of at least 10. For purposes of Sec.
721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), and (g)(5). For purposes of Sec.
721.72(e), the concentration is set at 1.0%. For purposes of Sec.
721.72(g)(1), this substance may cause: Skin irritation; 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)(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 (h) and (k) 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.
[[Page 67006]]
Sec. 721.11642 N-alkyl heteromonocyclic diphenolamide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as N-alkyl
heteromonocyclic diphenolamide (PMN P-20-26) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3) through (5), (b), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) and (a)(4), engineering control measures (e.g., enclosure
or confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. For purposes of Sec. 721.63(a)(5), respirators must
provide a National Institute for Occupational Safety and Health (NIOSH)
assigned protection factor (APF) of at least 10,000. For purposes of
Sec. 721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(3), and (g)(5). For purposes of
Sec. 721.72(e), the concentration is set at 1.0%. For purposes of
Sec. 721.72(g)(1), this substance may cause: Skin irritation; skin
corrosion; eye irritation; serious eye damage; reproductive toxicity;
specific target organ toxicity. For purposes of Sec. 721.72(g)(3),
this substance may cause: Aquatic toxicity. Alternative hazard and
warning statements that meet the criteria of the Globally Harmonized
System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(g) and (t).
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=41.
(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 and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725 (b)(1) apply to paragraph (a)(2)(iii)
of this section.
Sec. 721.11643 Reaction products of alkyl-terminated
alkylalumuminoxanes and [[(pentaalkylphenyl-
(pentaalkylphenyl)amino)alkyl]alkanediaminato]bis(aralkyl) transition
metal coordination compound (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
reaction products of alkyl-terminated alkylalumuminoxanes and
[[(pentaalkylphenyl-
(pentaalkylphenyl)amino)alkyl]alkanediaminato]bis(aralkyl) transition
metal coordination compound (PMN P-20-46) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section. The requirements of this section do not apply to
quantities of the substance after they have been completely reacted or
cured.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3), (b), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. For purposes of
Sec. 721.63(b), the concentration is set at 0.1%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(3), and (g)(5). For purposes of
Sec. 721.72(e), the concentration is set at 0.1%. For purposes of
Sec. 721.72(g)(1), this substance may cause: Skin corrosion; skin
irritation; serious eye damage; carcinogenicity; reproductive toxicity;
specific target organ toxicity. For purposes of Sec. 721.72(g)(3),
this substance may cause: Aquatic toxicity. Alternative hazard and
warning statements that meet the criteria of the Globally Harmonized
System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(a) through (c).
(iv) Disposal. Requirements as specified in Sec. 721.85(b)(1) and
(c)(1). It is a significant new use to release the substance directly
to air.
(v) 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 (k) 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. 721.11644 Multi-walled carbon nanotubes (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as multi-
walled carbon nanotubes (PMN P-20-72) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section. The requirements of this section do not apply to
quantities of the substance after they have been completely reacted or
cured.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3) through (5), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) and (a)(4), engineering control measures (e.g., enclosure
or confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. For purposes of Sec. 721.63(a)(5), respirators must
include a N-100, P-100, or R-100 cartridge and provide a National
Institute for Occupational Safety and Health (NIOSH) assigned
protection factor (APF) of at least 50.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(3), and (g)(5). For purposes of
Sec. 721.72(g)(1), this substance may cause: Eye irritation;
respiratory sensitization; skin sensitization; carcinogenicity;
specific target organ toxicity. For purposes of Sec. 721.72(g)(3),
this substance may cause: Unknown aquatic toxicity. Alternative hazard
and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (k) and (t). It is a significant new
use to import the substance such that the maximum weight percentage of
the confidential impurity exceeds the confidential percentage specified
in the Order. It is a significant new use to import the
[[Page 67007]]
substance other than as confidentially described in the PMN and allowed
in the Order. It is a significant new use to process or use the
substance in application methods that generate a dust, mist, spray,
vapor, or aerosol unless such application method occurs in an enclosed
process.
(iv) Disposal. Requirements as specified in Sec. 721.85(b)(1),
(b)(2), (c)(1), and (c)(2). It is a significant new use to release the
substance directly to air.
(v) 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 (k) 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.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.
Sec. 721.11645 Carbomonocyclic sulfonium, salt with trihalo-
sulfoalkyl hydroxycarbopolycyclic carboxylate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
carbomonocyclic sulfonium, salt with trihalo-sulfoalkyl
hydroxycarbopolycyclic carboxylate (PMN P-20-120) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section. The requirements of this section do
not apply to quantities of the substance after they have been
completely reacted or adhered onto a semiconductor wafer surface or
similar manufactured article used in the production of semiconductor
technologies.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) and (iii), (a)(3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii) and (v),
(g)(3)(i) and (ii), and (g)(5). For purposes of Sec. 721.72(e), the
concentration is set at 1%. For purposes of Sec. 721.72(g)(1), this
substance may cause: Skin irritation; acute toxicity; skin
sensitization; serious eye damage; specific target organ toxicity;
neurotoxicity; genetic toxicity; reproductive toxicity. Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (k), and (t). It is a significant new
use to import the substance other than in solution, unless in sealed
containers weighing 5 kilograms or less. It is a significant new use to
process the substance in any way that generates dust, mist, or aerosol
in a non-enclosed process. It is a significant new use to manufacture
the substance longer than 18 months.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers and processors
of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.
Sec. 721.11646 Heterocyclic onium compound with 1-substituted-alkyl
2,2,2-trisubstitutedalkyl 2-methyl-2-propenoate (1:1) polymer with
acenaphthylene, 4-ethenyl-a,a-dimethylbenzenemethanol and 4-
ethenylphenyl acetate, hydrolyzed (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
heterocyclic onium compound with 1-substituted-alkyl 2,2,2-
trisubstitutedalkyl 2-methyl-2-propenoate (1:1) polymer with
acenaphthylene, 4-ethenyl-a,a-dimethylbenzenemethanol and 4-
ethenylphenyl acetate, hydrolyzed (PMN P-20-122) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section. The requirements of this section do
not apply to quantities of the substance after they have been
completely reacted or adhered (during photolithographic processes) onto
a semiconductor wafer surface or similar manufactured article used in
the production of semiconductor technologies.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) and (iii), (a)(3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii) and (v),
(g)(3)(i) and (ii), and (g)(5). For purposes of Sec. 721.72(e), the
concentration is set at 1%. For purposes of Sec. 721.72(g)(1), this
substance may cause: Skin irritation; acute toxicity; skin
sensitization; serious eye damage; specific target organ toxicity;
neurotoxicity; genetic toxicity; reproductive toxicity. Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (k), and (t). It is a significant new
use to import the substance other than in solution, unless in sealed
containers weighing 5 kilograms or less. It is a significant new use to
process the substance in any way that generates dust, mist, or aerosol
in a non-enclosed process. It is a significant new use to manufacture
the substance longer than 18 months.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers and processors
of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.
Sec. 721.11647 Sulfonium, triphenyl-, 1,2-substituted-
alkyltricycloalkyl-1-carboxylate (1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting.
[[Page 67008]]
(1) The chemical substance identified generically as sulfonium,
triphenyl-, 1,2-substituted-alkyltricycloalkyl-1-carboxylate (1:1) (PMN
P-20-139) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substance after they have been completely reacted or adhered (during
photolithographic processes) onto a semiconductor wafer surface or
similar manufactured article used in the production of semiconductor
technologies.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) and (iii), (a)(3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii) and (v),
(g)(3)(i) and (ii), and (g)(5). For purposes of Sec. 721.72(e), the
concentration is set at 1%. For purposes of Sec. 721.72(g)(1), this
substance may cause: Skin irritation; acute toxicity; skin
sensitization; serious eye damage; specific target organ toxicity;
neurotoxicity; genetic toxicity; reproductive toxicity. Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (k), and (t). It is a significant new
use to import the substance other than in solution, unless in sealed
containers weighing 5 kilograms or less. It is a significant new use to
process the substance in any way that generates dust, mist, or aerosol
in a non-enclosed process. It is a significant new use to manufacture
the substance longer than 18 months.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers and processors
of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.
Sec. 721.11648 N-substituted-beta-alanine, heterosubstituted-alkyl
ester, ion(1-), triphenyl sulfonium (1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as n-
substituted-beta-alanine, heterosubstituted-alkyl ester, ion(1-),
triphenyl sulfonium (1:1) (PMN P-20-140) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section. The requirements of this section do not apply to
quantities of the substance after they have been completely reacted or
adhered (during photolithographic processes) onto a semiconductor wafer
surface or similar manufactured article used in the production of
semiconductor technologies.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) and (iii), (a)(3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii) and (v),
(g)(3)(i) and (ii), and (g)(5). For purposes of Sec. 721.72(e), the
concentration is set at 1%. For purposes of Sec. 721.72(g)(1), this
substance may cause: Skin irritation; acute toxicity; skin
sensitization; serious eye damage; specific target organ toxicity;
neurotoxicity; genetic toxicity; reproductive toxicity. Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f) and (t). It is a significant new use to
use the substance other than as a photoacid generator for chemically
amplified photoresist. It is a significant new use to import the
substance other than in solution, unless in sealed containers weighing
5 kilograms or less. It is a significant new use to process the
substance in any way that generates dust, mist, or aerosol in a non-
enclosed process. It is a significant new use to manufacture the
substance longer than 18 months.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers and processors
of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.
Sec. 721.11649 Sulfonium, [4-(1,1-dimethylethyl)phenyl]diphenyl-,
salt with heterosubstituted-alkyl tricycloalkane-carboxylate (1:1)
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonium, [4-(1,1-dimethylethyl)phenyl]diphenyl-, salt with
heterosubstituted-alkyl tricycloalkane-carboxylate (1:1) (PMN P-20-141)
is subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the substance after they have
been completely reacted or adhered (during photolithographic processes)
onto a semiconductor wafer surface or similar manufactured article used
in the production of semiconductor technologies.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) and (iii), (a)(3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii) and (v),
(g)(3)(i) and (ii), and (g)(5). For purposes of Sec. 721.72(e), the
concentration is set at 1%. For purposes of Sec. 721.72(g)(1), this
substance may cause: Skin irritation; acute toxicity; skin
sensitization; serious eye damage; specific target organ toxicity;
[[Page 67009]]
neurotoxicity; genetic toxicity; reproductive toxicity. Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (k), and (t). It is a significant new
use to import the substance other than in solution, unless in sealed
containers weighing 5 kilograms or less. It is a significant new use to
process the substance in any way that generates dust, mist, or aerosol
in a non-enclosed process. It is a significant new use to manufacture
the substance longer than 18 months.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers and processors
of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.
Sec. 721.11650 Dibenzothiophenium, 5-phenyl-, salt with 2,2-
diheterosubstituted-2-sulfoethyl substituted-heterotricycloalkane-
carboxylate (1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
dibenzothiophenium, 5-phenyl-, salt with 2,2-diheterosubstituted-2-
sulfoethyl substituted-heterotricycloalkane-carboxylate (1:1) (PMN P-
20-142) is subject to reporting under this section for the significant
new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substance after they have been completely reacted or adhered (during
photolithographic processes) onto a semiconductor wafer surface or
similar manufactured article used in the production of semiconductor
technologies.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) and (iii), (a)(3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii) and (v),
(g)(3)(i) and (ii), and (g)(5). For purposes of Sec. 721.72(e), the
concentration is set at 1%. For purposes of Sec. 721.72(g)(1), this
substance may cause: Skin irritation; acute toxicity; skin
sensitization; serious eye damage; specific target organ toxicity;
neurotoxicity; genetic toxicity; reproductive toxicity. Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (k), and (t). It is a significant new
use to import the substance other than in solution, unless in sealed
containers weighing 5 kilograms or less. It is a significant new use to
process the substance in any way that generates dust, mist, or aerosol
in a non-enclosed process. It is a significant new use to manufacture
the substance longer than 18 months.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers and processors
of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.
Sec. 721.11651 Substituted heterocyclic onium compound, salt with
heteropolysubstitutedalkyl substitutedtricycloalkanecarboxylate (1:1),
polymer with disubstituted aromatic compound and 1-methylcyclopentyl 2-
methyl-2-propenoate, di-Me 2,2'-(1,2-diazenediyl)bis[2-
methylpropenoate]-initiated (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted heterocyclic onium compound, salt with
heteropolysubstitutedalkyl substitutedtricycloalkanecarboxylate (1:1),
polymer with disubstituted aromatic compound and 1-methylcyclopentyl 2-
methyl-2-propenoate, di-Me 2,2'-(1,2-diazenediyl)bis[2-
methylpropenoate]-initiated (PMN P-20-145) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section. The requirements of this section do not apply
to quantities of the substance after they have been completely reacted
or adhered (during photolithographic processes) onto a semiconductor
wafer surface or similar manufactured article used in the production of
semiconductor technologies.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) and (iii), (a)(3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii) and (v),
(g)(3)(i) and (ii), and (g)(5). For purposes of Sec. 721.72(e), the
concentration is set at 1%. For purposes of Sec. 721.72(g)(1), this
substance may cause: Skin irritation; acute toxicity; skin
sensitization; serious eye damage; specific target organ toxicity;
neurotoxicity; genetic toxicity; reproductive toxicity. Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (k), and (t). It is a significant new
use to import the substance other than in solution, unless in sealed
containers weighing 5 kilograms or less. It is a significant new use to
process the substance in any way that generates dust, mist, or aerosol
in a non-enclosed process. It is a significant new use to manufacture
the substance longer than 18 months.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers and processors
of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
[[Page 67010]]
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.
Sec. 721.11652 Substituted-2H-thiopyrylium, salt with
heterosubstituted-alkyl tricycloalkane-carboxylate (1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted-2H-thiopyrylium, salt with heterosubstituted-alkyl
tricycloalkane-carboxylate (1:1) (PMN P-20-147) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section. The requirements of this section do not apply
to quantities of the substance after they have been completely reacted
or adhered (during photolithographic processes) onto a semiconductor
wafer surface or similar manufactured article used in the production of
semiconductor technologies.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) and (iii), (a)(3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii) and (v),
(g)(3)(i) and (ii), and (g)(5). For purposes of Sec. 721.72(e), the
concentration is set at 1%. For purposes of Sec. 721.72(g)(1), this
substance may cause: Skin irritation; acute toxicity; skin
sensitization; serious eye damage; specific target organ toxicity;
neurotoxicity; genetic toxicity; reproductive toxicity. Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (k), and (t). It is a significant new
use to import the substance other than in solution, unless in sealed
containers weighing 5 kilograms or less. It is a significant new use to
process the substance in any way that generates dust, mist, or aerosol
in a non-enclosed process. It is a significant new use to manufacture
the substance longer than 18 months.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers and processors
of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.
Sec. 721.11653 Sulfonium, triphenyl-, salt with 2,2-dihalo-2-
sulfoethyl-2-oxo substituted-heterotricycloalkane-heteropolycyclo-
carboxylate (1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonium, triphenyl-, salt with 2,2-dihalo-2-sulfoethyl-2-oxo
substituted-heterotricycloalkane-heteropolycyclo-carboxylate (1:1) (PMN
P-20-152) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substance after they have been completely reacted or adhered (during
photolithographic processes) onto a semiconductor wafer surface or
similar manufactured article used in the production of semiconductor
technologies.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) and (iii), (a)(3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii) and (v),
(g)(3)(i) and (ii), and (g)(5). For purposes of Sec. 721.72(e), the
concentration is set at 1%. For purposes of Sec. 721.72(g)(1), this
substance may cause: Skin irritation; acute toxicity; skin
sensitization; serious eye damage; specific target organ toxicity;
neurotoxicity; genetic toxicity; reproductive toxicity. Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (k), and (t). It is a significant new
use to import the substance other than in solution, unless in sealed
containers weighing 5 kilograms or less. It is a significant new use to
process the substance in any way that generates dust, mist, or aerosol
in a non-enclosed process. It is a significant new use to manufacture
the substance longer than 18 months.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers and processors
of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.
Sec. 721.11654 Sulfonium, triphenyl-, salt with 5-alkyl-2-alkyl-4-
(2,4,6-substituted tri-carbomonocycle, hetero-acid) benzenesulfonate
(1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonium, triphenyl-, salt with 5-alkyl-2-alkyl-4-(2,4,6-substituted
tri-carbomonocycle, hetero-acid) benzenesulfonate (1:1) (PMN P-20-155)
is subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the substance after they have
been completely reacted or adhered (during photolithographic processes)
onto a semiconductor wafer surface or similar manufactured article used
in the production of semiconductor technologies.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) and (iii), (a)(3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a)
[[Page 67011]]
through (f), (g)(1), (g)(2)(i) through (iii) and (v), (g)(3)(i) and
(ii), and (g)(5). For purposes of Sec. 721.72(e), the concentration is
set at 1%. For purposes of Sec. 721.72(g)(1), this substance may
cause: Skin irritation; acute toxicity; skin sensitization; serious eye
damage; specific target organ toxicity; neurotoxicity; genetic
toxicity; reproductive toxicity. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (k), and (t). It is a significant new
use to import the substance other than in solution, unless in sealed
containers weighing 5 kilograms or less. It is a significant new use to
process the substance in any way that generates dust, mist, or aerosol
in a non-enclosed process. It is a significant new use to manufacture
the substance longer than 18 months.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers and processors
of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.
Sec. 721.11655 Phenoxanthiinium, 10-phenyl, 5-alkyl-2-alkyl-4-(2,4,6-
substituted tri-carbomonocycle, hetero-acid) benzenesulfonate (1:1)
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
phenoxanthiinium, 10-phenyl, 5-alkyl-2-alkyl-4-(2,4,6-substituted tri-
carbomonocycle, hetero-acid) benzenesulfonate (1:1) (PMN P-20-159) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the substance after they have
been completely reacted or adhered (during photolithographic processes)
onto a semiconductor wafer surface or similar manufactured article used
in the production of semiconductor technologies.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) and (iii), (a)(3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii) and (v),
(g)(3)(i) and (ii), and (g)(5). For purposes of Sec. 721.72(e), the
concentration is set at 1%. For purposes of Sec. 721.72(g)(1), this
substance may cause: Skin irritation; acute toxicity; skin
sensitization; serious eye damage; specific target organ toxicity;
neurotoxicity; genetic toxicity; reproductive toxicity. Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (k), and (t). It is a significant new
use to import the substance other than in solution, unless in sealed
containers weighing 5 kilograms or less. It is a significant new use to
process the substance in any way that generates dust, mist, or aerosol
in a non-enclosed process. It is a significant new use to manufacture
the substance longer than 18 months.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers and processors
of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.
Sec. 721.11656 Substituted, triaryl-, tricycloalkane alkyl
disubstituted (generic) (P-20-156).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted, triaryl-, tricycloalkane alkyl disubstituted (PMN P-20-
156) is subject to reporting under this section for the significant new
uses described in paragraph (a)(2) of this section. The requirements of
this section do not apply to quantities of the substance after they
have been completely reacted or adhered (during photolithographic
processes) onto a semiconductor wafer surface or similar manufactured
article used in the production of semiconductor technologies.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) and (iii), (a)(3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii) and (v),
(g)(3)(i) and (ii), and (g)(5). For purposes of Sec. 721.72(e), the
concentration is set at 1%. For purposes of Sec. 721.72(g)(1), this
substance may cause: Skin irritation; acute toxicity; skin
sensitization; serious eye damage; specific target organ toxicity;
neurotoxicity; genetic toxicity; reproductive toxicity. Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (k), and (t). It is a significant new
use to import the substance other than in solution, unless in sealed
containers weighing 5 kilograms or less. It is a significant new use to
process the substance in any way that generates dust, mist, or aerosol
in a non-enclosed process. It is a significant new use to manufacture
the substance longer than 18 months.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers and processors
of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.
[[Page 67012]]
Sec. 721.11657 Substituted, triaryl-, tricycloalkane alkyl
disubstituted (generic) (P-20-162).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted, triaryl-, tricycloalkane alkyl disubstituted (PMN P-20-
162) is subject to reporting under this section for the significant new
uses described in paragraph (a)(2) of this section. The requirements of
this section do not apply to quantities of the substance after they
have been completely reacted or adhered (during photolithographic
processes) onto a semiconductor wafer surface or similar manufactured
article used in the production of semiconductor technologies.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) and (iii), (a)(3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii) and (v),
(g)(3)(i) and (ii), and (g)(5). For purposes of Sec. 721.72(e), the
concentration is set at 1%. For purposes of Sec. 721.72(g)(1), this
substance may cause: Skin irritation; acute toxicity; skin
sensitization; serious eye damage; specific target organ toxicity;
neurotoxicity; genetic toxicity; reproductive toxicity. Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (k), and (t). It is a significant new
use to import the substance other than in solution, unless in sealed
containers weighing 5 kilograms or less. It is a significant new use to
process the substance in any way that generates dust, mist, or aerosol
in a non-enclosed process. It is a significant new use to manufacture
the substance longer than 18 months.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers and processors
of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.
Sec. 721.11658 Naphthalene derivative (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
naphthalene derivative (PMN P-21-6) 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)(1) and (3) through (5). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1) and
(a)(4), engineering control measures (e.g., enclosure or confinement of
the operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. For purposes of
Sec. 721.63(a)(5), respirators must provide a National Institute for
Occupational Safety and Health (NIOSH) assigned protection factor (APF)
of at least 50.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(3) and (g)(5). For purposes of
Sec. 721.72(g)(1), this substance may cause: Acute toxicity; skin
irritation; skin sensitization; germ cell mutagenicity; reproductive
toxicity; specific target organ toxicity. For purposes of Sec.
721.72(g)(3), this substance may cause: Aquatic 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) and (k).
(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 and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.
[FR Doc. 2021-24790 Filed 11-23-21; 8:45 am]
BILLING CODE 6560-50-P