Significant New Use Rules on Certain Chemical Substances (20-2.5e), 64280-64306 [2020-21471]
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Federal Register / Vol. 85, No. 197 / Friday, October 9, 2020 / Proposed Rules
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 721
[EPA–HQ–OPPT–2020–0131; FRL–10011–
86]
RIN 2070–AB27
Significant New Use Rules on Certain
Chemical Substances (20–2.5e)
I. General Information
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
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). The SNURs require persons
who intend to manufacture (defined by
statute to include import) or process any
of these chemical substances for an
activity that is proposed as a significant
new use by this rule to notify EPA at
least 90 days before commencing that
activity. The required notification
initiates EPA’s evaluation of the use,
under the conditions of use for that
chemical substance, within the
applicable review period. Persons may
not commence manufacture or
processing for the significant new use
until EPA has conducted a review of the
notice, made an appropriate
determination on the notice, and has
taken such actions as are required by
that determination.
DATES: Comments must be received on
or before November 9, 2020.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPPT–2020–0131,
through the Federal eRulemaking Portal
at https://www.regulations.gov. Follow
the online instructions for submitting
comments. Do not submit electronically
any information you consider to be
Confidential Business Information (CBI)
or other information whose disclosure is
restricted by statute.
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, Chemical Control
Division (7405M), Office of Pollution
Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania
SUMMARY:
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Ave. NW, Washington, DC 20460–0001;
telephone number: (202) 564–4163;
email address: wysong.william@epa.gov.
For general information contact: The
TSCA-Hotline, ABVI-Goodwill, 422
South Clinton Ave., Rochester, NY
14620; telephone number: (202) 554–
1404; email address: TSCA-Hotline@
epa.gov.
SUPPLEMENTARY INFORMATION:
A. Does this action apply to me?
You may be potentially affected by
this action if you manufacture, process,
or use the chemical substances
contained in this proposed rule. The
following list of North American
Industrial Classification System
(NAICS) codes is not intended to be
exhaustive, but rather provides a guide
to help readers determine whether this
document applies to them. Potentially
affected entities may include:
• Manufacturers or processors of one
or more subject chemical substances
(NAICS codes 325 and 324110), e.g.,
chemical manufacturing and petroleum
refineries.
This action may also affect certain
entities through pre-existing import
certification and export notification
rules under TSCA. Chemical importers
are subject to the TSCA section 13 (15
U.S.C. 2612) import provisions
promulgated at 19 CFR 12.118 through
12.127 and 19 CFR 127.28. Chemical
importers must certify that the shipment
of the chemical substance complies with
all applicable rules and Orders under
TSCA, which would include the SNUR
requirements should these proposed
rules be finalized. The EPA policy in
support of import certification appears
at 40 CFR part 707, subpart B. In
addition, pursuant to 40 CFR 721.20,
any persons who export or intend to
export a chemical substance that is the
subject of this proposed rule on or after
November 9, 2020 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
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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/
comments.html.
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 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–2020–0131, 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
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sections 5(h)(1), (h)(2), (h)(3), and (h)(5),
and the regulations at 40 CFR part 720.
Once EPA receives a SNUN and before
the manufacture or processing for the
significant new use can commence, EPA
must either determine that the use is not
likely to present an unreasonable risk of
injury under the conditions of use for
the chemical substance or take such
regulatory action as is associated with
an alternative determination. If EPA
determines that the use is not likely to
present an unreasonable risk, EPA is
required under TSCA section 5(g) to
make public, and submit for publication
in the Federal Register, a statement of
EPA’s findings.
III. Significant New Use Determination
TSCA section 5(a)(2) states that EPA’s
determination that a use of a chemical
substance is a significant new use must
be made after consideration of all
relevant factors, including:
• The projected volume of
manufacturing and processing of a
chemical substance.
• The extent to which a use changes
the type or form of exposure of human
beings or the environment to a chemical
substance.
• The extent to which a use increases
the magnitude and duration of exposure
of human beings or the environment to
a chemical substance.
• The reasonably anticipated manner
and methods of manufacturing,
processing, distribution in commerce,
and disposal of a chemical substance.
In determining what would constitute
a significant new use for the chemical
substances that are the subject of these
SNURs, EPA considered relevant
information about the toxicity of the
chemical substances, potential human
exposures and environmental releases
that may be associated with possible
uses of these chemical substances, in
the context of the four TSCA section
5(a)(2) factors listed in this unit.
The proposed rules include PMN
substances that are subject to Orders
issued under TSCA section 5(e)(1)(A), as
required by the determinations made
under TSCA section 5(a)(3)(B). The
TSCA Orders require protective
measures to limit exposures or
otherwise mitigate the potential
unreasonable risk. The proposed SNURs
identify significant new uses as any
manufacturing, processing, use,
distribution in commerce, or disposal
that does not conform to the restrictions
imposed by the underlying TSCA
Orders, consistent with TSCA section
5(f)(4).
Where EPA determined that the PMN
substance may present an unreasonable
risk of injury to human health via
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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.
These proposed rules include PMN
substances that received ‘‘not likely to
present an unreasonable risk’’
determination in TSCA section
5(a)(3)(c). However, during the course of
these reviews, EPA identified concerns
for certain health and/or environmental
risks if the chemicals were not used
following the limitations identified by
the submitters in the notices. The
proposed SNURs would identify as
significant new uses any manufacturing,
processing, use, distribution in
commerce, or disposal that does not
conform to the protection measures.
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 nonconfidential chemical identities).
• Basis for the SNUR or TSCA Order.
• Effective date of the TSCA Order (if
applicable).
• Potentially Useful Information.
• CFR citation assigned in the
regulatory text section of the proposed
rule.
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The chemicals subject to these
proposed SNURs are as follows:
PMN Numbers: P–18–241, P–18–244,
and P–18–245.
Chemical Names: 2-Propenoic acid, 2methyl-, methyl ester, polymer with
ethenylbenzene, ethyl 2-propenoate, 2oxiranylmethyl 2-methyl-2-propenoate
and 1,2-propanediol mono(2-methyl-2propenoate), reaction products with
diethanolamine, polymers with
substituted-alkyl acrylate, formats (salts)
(P–18–241) (generic); 2-Propenoic acid,
2-methyl, methyl ester, polymer with
ethenylbenzene, ethyl 2-propenoate, 2oxiranylmethyl 2-methyl-2-propenoate
and 1,2-propanediol mono(2-methyl-2propenoate), reaction products with
diethanolamine, polymers with
substituted-alkyl methacrylate, formats
(salts) (P–18–244) (generic); 2-Propenoic
acid, 2-methyl-, methyl ester, polymer
with ethenylbenzene, ethyl 2propenoate, 2-oxrianylmethyl 2-methyl2-propenoate, and 1,2-propaneidol
mono(2-methyl-2-propenoate), reaction
products with diethanolamine,
polymers with alkylene glycol
monoacrylate, formats (salts) (P–18–245)
(generic).
CAS Numbers: Not available.
Basis for the action: The PMNs state
that the generic (non-confidential) use
of the substances will be as additives for
automotive coatings. EPA estimated the
human health hazard of the chemical
substances based on their measured and
estimated physical/chemical properties
and by comparison with structurally
analogous chemical substances. EPA
determined environmental hazard for
the new chemical substances based on
Structural Activity Relationships (SAR)
analysis for polycationic polymers. EPA
has identified concerns for potential
neurotoxicity, blood toxicity,
reproductive and developmental
toxicity, and moderate environmental
hazard if the chemical substances are
not manufactured and not used
following the limitations identified by
the submitters in the notices. This
proposed SNUR designates the
following circumstances of use as
‘‘significant new uses’’ requiring further
review by EPA:
• Use of the PMN substances other
than as described in the PMNs.
Potentially useful information: EPA
has determined that information about
the human health and environmental
effects of the PMN substances may be
potentially useful if a manufacturer or
processor is considering submitting a
SNUN for a significant new use that
would be designated by this proposed
SNUR. EPA has determined that the
results of neurotoxicity, reproductive/
developmental toxicity, and aquatic
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toxicity testing would help characterize
the potential health and environmental
effects of the PMN substances.
CFR Citations: 40 CFR 721.11401 (P–
18–241), 40 CFR 721.11402 (P–18–244),
and 40 CFR 721.11403 (P–18–245).
PMN Numbers: P–16–539, P–18–157,
P–18–158, P–18–159, and P–19–33.
Chemical Names: Organic sulfonate
compound (generic) (P–16–539),
thiophenium, 1-(2,7-disubstituted-1naphthalenyl)tetrahydro-, salt with
polyfluoro-N-polyfluoroalkylsulfonyl-1alkanesulfonamide (1:1) (generic) (P–
18–157), sulfonium, triphenyl-, salt with
2,3-bis(substituted) 5sulfocarbopolycyclic-2,3-carboxylate
derivative (1:1) (generic) (P–18–158),
thiophenium, 1-(2,7-disubstituted-1naphthalenyl)tetrahydro-, salt with
polyfluoro-N-polyfluoroalkylsulfonyl-1alkanesulfonamide (1:1) (P–18–159),
and sulfonium, triphenyl-, 5-(alkyl)
fluoropentane derivative (generic) (P–
19–33).
CAS Numbers: Not available.
Effective Date of TSCA Order: January
31, 2020.
Basis for TSCA Order: The PMNs state
that the generic (non-confidential) use
of the substances will be for
photolithography (P–16–539, P–18–158,
and P–19–33) and as a photosensitizer
for photoresist (P–18–158 and P–18–
159). 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 the New Chemical Program’s PBT
category policy statement (64 FR 60194,
November 4, 1999; 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 physical/
chemical properties and comparison
with analogous chemical substances,
EPA has also identified concerns for
photosensitization, eye corrosion,
irritation, acute toxicity, neurotoxicity,
lung overload, aquatic toxicity, and
reproductive/developmental toxicity.
The TSCA 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 TSCA Order requires:
1. No manufacture of any of the PMN
substances beyond the time limits
specified in the TSCA Order without
submittal to EPA of the results of certain
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testing described in the Testing section
of the TSCA Order;
2. Use of personal protective
equipment where there is a potential for
dermal exposure;
3. Establishment of a hazard
communication program, including
human health precautionary statements
on each label and in the Safety Data
Sheet (SDS);
4. No modification of the processing
of the PMN substances in any way that
generates a dust, mist, or aerosol in a
non-enclosed process;
5. Use of the PMN substances only as
described in the TSCA Order;
6. No domestic manufacture of the
PMN substances (i.e., import only);
7. Import of the PMN substances only
in solution, or in any form in sealed
containers weighing 5 kilograms or less;
and
8. No exceedance of the confidential
annual production volumes listed in the
TSCA 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 TSCA
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 TSCA Order without
performing the required Tier I and Tier
II testing outlined in the Testing section
of the TSCA Order.
CFR Citations: 40 CFR 721.11514 (P–
16–539), 40 CFR 721.11515 (P–18–157),
40 CFR 721.11516 (P–18–158), 40 CFR
721.11517 (P–18–159), and 40 CFR
721.11518 (P–19–33).
PMN Numbers: P–17–178, P–18–13,
P–18–14, P–18–37, P–19–78, P–19–79, P–
19–111, P–19–112, P–19–114 and P–19–
133.
Chemical Names: Sulfonium,
triphenyl-, salt with substituted-alkyl 4substituted-benzoate (generic) (P–17–
178), substituted-triphenylsulfonium,
inner salt (generic) (P–18–13),
sulfonium, triphenyl-, salt with
disubstituted-heterocyclic compound
(1:1) (generic) (P–18–14), sulfonium,
triphenyl-, salt with 2,4,5-trisubstitutedbenzenesulfonate (1:1) (generic) (P–18–
37), substituted heterocyclic onium
compound, salt with 2,2,2-trifluoro-1(sulfomethyl)-1-(trifluoromethyl)ethyl 3[(2-methyl-1-oxo-2-propen-1-
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yl)oxy]tricyclo[3.3.1.13,7]decane-1carboxylate (1:1), polymer with
acenaphthylene, 1-ethenyl-4-[(1ethylcyclopentyl)oxy]benzene and 4ethenylphenol, di-Me 2,2′-(1,2diazenediyl)bis[2-methylpropanoate]initiated (generic) (P–19–78),
substituted heterocyclic onium
compound, salt with 2,2,2-trifluoro-1(sulfomethyl)-1-(trifluoromethyl)ethyl 3[(2-methyl-1-oxo-2-propen-1yl)oxy]tricyclo[3.3.1.13,7]decane-1carboxylate (1:1), polymer with
acenaphthylene 1-ethenyl-4-[[1-(1methylethyl)cyclopentyl]oxy]benzene
and 4-ethenylphenol, di-Me 2,2′-(1,2diazenediyl)bis[2-methylpropanoate]initiated (generic) (P–19–79),
dibenzothiophenium, aryl substituted
trifluoro-hydroxy(triheterosubstitutedalkyl)alkanoate
(1:1) (generic) (P–19–111), substituted
heterocyclic onium compound, salt with
1-(difluorosulfomethyl)-2,2,2trifluoroethyl 3-[(2-methyl-1-oxo-2propen-1yl)oxy]tricyclo[3.3.1.13,7]decane-1carboxylate (1:1), polymer with 3ethenylphenol, 1-(1methylethyl)cyclopentyl 2-methyl-2propenoate and 1-(7oxabicyclo[2.2.1]hept-2-yl)cyclopentyl
2-methyl-2-propenoate, di-Me 2,2′-(1,2diazenediyl)bis[2-methylpropenoate]initiated (generic) (P–19–112),
sulfonium, triphenyl-, trifluorohydroxy(triheterosubstitutedalkyl)alkanoate
(1:1) (generic) (P–19–114), and
heterotrisubstituted-bile acid, 1(difluorosulfomethyl)-2,2,2trifluoroethyl ester, ion(1-), (5)-,
triphenylsulfonium (1:1) (generic) (P–
19–133).
CAS Numbers: Not available.
Effective Date of TSCA Order: January
31, 2020.
Basis for TSCA Order: The PMNs state
that the generic (non-confidential) uses
of the substances will be for
microlithography for electronic device
manufacturing (P–17–178, P–18–13, P–
18–14, and P–18–37), polymers for
photo resist (P–19–78 and P–17–79),
and microlithography for electronic
device manufacturing (P–19–78, P–19–
79, P–19–111, P–19–112, P–19–114, and
P–19–133). Based on the physical/
chemical properties of the PMN
substances and test data on structurally
similar substances, the PMN substances
are potentially PBT chemicals (as
described in the New Chemical
Program’s PBT category policy
statement (64 FR 60194, November 4,
1999; FRL–6097–7)). EPA estimates that
the PMN substances will persist in the
environment more than 2 months and
estimates a bioaccumulation factor of
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greater than or equal to 1,000. Based on
physical/chemical properties and
comparison with analogous chemical
substances, EPA has also identified
concerns for photosensitization, eye
corrosion, irritation, acute toxicity,
neurotoxicity, lung overload, aquatic
toxicity, and reproductive/
developmental toxicity. 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 TSCA
Order requires:
1. No manufacture of any of the PMN
substances beyond the time limits
specified in the TSCA Order without
submittal to EPA of the results of certain
testing described in the Testing section
of the TSCA Order;
2. Use of personal protective
equipment where there is a potential for
dermal exposure;
3. Establishment of a hazard
communication program, including
human health precautionary statements
on each label and in the SDS;
4. No modification of the processing
of the PMN substances in any way that
generates a dust, mist, or aerosol in a
non-enclosed process;
5. Use of the PMN substances only as
described in the TSCA Order;
6. No domestic manufacture of the
PMN substances (i.e., import only);
7. Import of the PMN substances only
in solution, or in any form in sealed
containers weighing 5 kilograms or less;
and
8. No exceedance of the confidential
annual importation volumes listed in
the TSCA 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 TSCA
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 TSCA Order without
performing the required Tier I and Tier
II testing outlined in the Testing section
of the TSCA Order.
CFR Citations: 40 CFR 721.11519 (P–
17–178), 40 CFR 721.11520 (P–18–13),
40 CFR 721.11521 (P–18–14), 40 CFR
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721.11522 (P–18–37), 40 CFR 721.11523
(P–19–78), 40 CFR 721.11524 (P–19–79),
40 CFR 721.11525 (P–19–111), 40 CFR
721.11526 (P–19–112), 40 CFR
721.11527 (P–19–114), and 40 CFR
721.11528 (P–19–133).
PMN Number: P–18–16.
Chemical Name: Aromatic sulfonium
tricyclo fluoroalkyl sulfonic acid salt
(generic).
CAS Number: None available.
Effective Date of TSCA Order:
February 11, 2020.
Basis for TSCA Order: The PMN states
that the generic (non-confidential) use
will be as a photoacid generator (PAG).
Based on the physical/chemical
properties of the PMN substance, the
PMN substance is a potentially PBT
chemical (as described in the New
Chemical Program’s PBT category policy
statement (64 FR 60194, November 4,
1999; 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 physical/chemical properties and
comparison with analogous chemical
substances, EPA has also identified
concerns for photosensitization, eye
corrosion, irritation, acute toxicity, liver
toxicity, neurotoxicity, reproductive/
developmental toxicity, and aquatic
toxicity. 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 TSCA Order requires:
1. No manufacture of the PMN
substance beyond the time limits
specified in the TSCA Order without
submittal to EPA of the results of certain
testing described in the Testing section
of the TSCA Order;
2. Use of personal protective
equipment where there is a potential for
dermal exposure;
3. Establishment of a hazard
communication program, including
human health precautionary statements
on each label and in the SDS;
4. No modification of the processing
of the PMN substance in any way that
generates a dust, mist, or aerosol in a
non-enclosed process;
5. Use of the PMN substance only as
described in the TSCA Order;
6. No domestic manufacture of the
PMN substance (i.e., import only);
7. Import of the PMN substance only
in solution, or in any form in sealed
containers weighing 5 kilograms or less;
and
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8. No exceedance of the confidential
annual importation volume listed in the
TSCA 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 TSCA
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 TSCA Order without
performing the required Tier I and Tier
II testing outlined in the Testing section
of the TSCA Order.
CFR Citation: 40 CFR 721.11529.
PMN Numbers: P–18–297, P–18–311,
P–18–314, and P–18–315.
Chemical Names: Substituted,
(alkylaromatic)diaromatic salt with
trihalo[(trihaloalkyl)substituted]substituted
alkaneamide (generic) (P–18–297),
triarylsulfonium substituted
oxatricycloalkyloxycarbonyl dihalo
alkane sulfonate (generic) (P–18–311),
substituted triarylsulfonium
carbopolycyclic heteromonocyclic
dihalo sulfoacetate (generic) (P–18–314),
and substituted triarylsulfonium
substituted carbopolycyclic carboxylate
(generic) (P–18–315).
CAS Numbers: Not available.
Effective Date of TSCA Order:
February 4, 2020.
Basis for TSCA Order: The PMNs state
that the generic (non-confidential) use
of the substances will be as components
of material for fabrication. Based on the
physical/chemical properties of the
PMN substances and test data on
structurally similar substances, the PMN
substances are potentially PBT
chemicals (as described in the New
Chemical Program’s PBT category policy
statement (64 FR 60194, November 4,
1999; FRL–6097–7)). EPA estimates that
the PMN substances will persist in the
environment more than 2 months and
estimates a bioaccumulation factor of
greater than or equal to 1,000. Based on
physical/chemical properties and
comparison with analogous chemical
substances, EPA has also identified
concerns for photosensitization, eye
corrosion, irritation, acute toxicity,
neurotoxicity, lung overload, aquatic
toxicity, and reproductive/
developmental toxicity. The Order was
issued under TSCA sections
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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 TSCA
Order requires:
1. No manufacture of any of the PMN
substances beyond the time limits
specified in the TSCA Order without
submittal to EPA of the results of certain
testing described in the Testing section
of the TSCA Order;
2. Use of personal protective
equipment where there is a potential for
dermal exposure;
3. Establishment of a hazard
communication program, including
human health precautionary statements
on each label and in the SDS;
4. No modification of the processing
of the PMN substances in any way that
generates a dust, mist, or aerosol in a
non-enclosed process;
5. Use of the PMN substances only as
described in the TSCA Order;
6. No domestic manufacture of the
PMN substances (i.e., import only);
7. Import of the PMN substances only
in solution, or in any form in sealed
containers weighing 5 kilograms or less;
and
8. No exceedance of the confidential
annual importation volumes listed in
the TSCA 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 TSCA
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 TSCA Order without
performing the required Tier I and Tier
II testing outlined in the Testing section
of the TSCA Order.
CFR Citations: 40 CFR 721.11530 (P–
18–297), 40 CFR 721.11531 (P–18–311),
40 CFR 721.11532 (P–18–314), and 40
CFR 721.11533 (P–18–315).
PMN Numbers: P–18–304, P–18–316,
P–18–338, P–19–76, P–19–115, and P–
19–142.
Chemical Names: Sulfonium,
bis(dihalocarbomonocycle)
carbomonocycle, salt with substituted
heteropolycycle dihalo sulfoalkanoate
(1:1) (generic) (P–18–304),
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heteropolycycle, alkylaromatic-, salt
with dihalo-substituted alkyl
carbopolycycle carboxylate (generic) (P–
18–316), sulfonium, triaryl-, salt with
polyhalo-4-sulfoalkyl polycarbocyclic
alkane-1-carboxylate (1:1) (P–18–338),
sulfonium, bis(dihalocarbomonocycle)
carbomonocycle, salt with dihalo
substituted alkyl carbopolycyclic
carboxylate (1:1) (generic) (P–19–76),
sulfonium, bis(dihalocarbomonocycle)
carbomonocycle, substituted
carbomonocyclic ester (generic) (P–19–
115), and heteropolycycle, aromatic-,
salt with dihalo-substituted alkyl
carbopolycycle carboxylate (1:1)
(generic) (P–19–142).
CAS Numbers: Not available.
Effective Date of TSCA Order: January
30, 2020.
Basis for TSCA Order: The PMNs state
that the generic (non-confidential) use
of the substances will be as ingredients
used in the manufacture of photoresist.
Based on the physical/chemical
properties of the PMN substances and
test data on structurally similar
substances, the PMN substances are
potentially PBT chemicals (as described
in the New Chemical Program’s PBT
category policy statement (64 FR 60194,
November 4, 1999; FRL–6097–7)). EPA
estimates that the PMN substances will
persist in the environment more than 2
months and estimates a
bioaccumulation factor of greater than
or equal to 1,000. Based on physical/
chemical properties and comparison
with analogous chemical substances,
EPA has also identified concerns for
photosensitization, eye corrosion,
irritation, acute toxicity, neurotoxicity,
lung overload, aquatic toxicity, and
reproductive/developmental toxicity.
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 TSCA Order requires:
1. No manufacture of any of the PMN
substances beyond the time limits
specified in the TSCA Order without
submittal to EPA of the results of certain
testing described in the Testing section
of the TSCA Order;
2. Use of personal protective
equipment where there is a potential for
dermal exposure;
3. Establishment of a hazard
communication program, including
human health precautionary statements
on each label and in the SDS;
4. No modification of the processing
of the PMN substances in any way that
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generates a dust, mist, or aerosol in a
non-enclosed process;
5. Use of the PMN substances only as
described in the PMNs;
6. No domestic manufacture of the
PMN substances (i.e., import only);
7. Import of the PMN substances only
in solution, or in any form in sealed
containers weighing 5 kilograms or less;
and
8. No exceedance of the confidential
annual importation volumes listed in
the TSCA 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 TSCA
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 TSCA Order without
performing the required Tier I and Tier
II testing outlined in the Testing section
of the TSCA Order.
CFR Citations: 40 CFR 721.11534 (P–
18–304), 40 CFR 721.11535 (P–18–316),
40 CFR 721.11536 (P–18–338), 40 CFR
721.11537 (P–19–76), 40 CFR 721.11538
(P–19–115), and 40 CFR 721.11539 (P–
19–142).
PMN Number: P–19–166.
Chemical Name: Triarylsulfonium
alkylestersulfonate (generic).
CAS Number: None available.
Effective Date of TSCA Order:
February 12, 2020.
Basis for TSCA Order: The PMN states
that the generic (non-confidential) use
will be as a photoacid generator (PAG).
Based on the physical/chemical
properties of the PMN substance, the
PMN substance is a potentially
persistent, bioaccumulative, and toxic
(PBT) chemical (as described in the New
Chemical Program’s PBT category at 64
FR 60194; November 1999). 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 physical/
chemical properties and comparison
with analogous chemical substances,
EPA has also identified concerns for
photosensitization, eye corrosion,
irritation, acute toxicity, liver toxicity,
neurotoxicity, reproductive/
developmental toxicity, and aquatic
toxicity. The Order was issued under
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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 TSCA Order requires:
1. No manufacture of the PMN
substance beyond the time limits
specified in the TSCA Order without
submittal to EPA of the results of certain
testing described in the Testing section
of the TSCA Order;
2. Use of personal protective
equipment where there is a potential for
dermal exposure;
3. Establishment of a hazard
communication program, including
human health precautionary statements
on each label and in the SDS;
4. No modification of the processing
of the PMN substance in any way that
generates a dust, mist, or aerosol in a
non-enclosed process;
5. Use of the PMN substance only as
described in the TSCA Order;
6. No domestic manufacture of the
PMN substance (import only);
7. Import of the PMN substance only
in solution, or in any form in sealed
containers weighing 5 kilograms or less;
and
8. No exceedance of the confidential
annual importation volume listed in the
TSCA 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 TSCA
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 TSCA Order without
performing the required Tier I and Tier
II testing outlined in the Testing section
of the TSCA Order.
CFR Citation: 40 CFR 721.11540.
PMN Numbers: P–19–168, P–19–169,
P–19–171, P–19–172, P–19–173, P–19–
175, P–19–176, P–19–177, P–19–178, P–
19–179, P–19–180, P–19–181, P–19–182,
P–19–184, and P–19–187.
Chemical Names: Halogenated
alkylbenzoic acid (generic) (P–19–168,
P–19–169, P–19–175, P–19–176, P–19–
177, P–19–178, and P–19–179),
halogenated benzoic acid (P–19–171, P–
19–172, and P–19–173), halogenated
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sodium benzoate (P–19–180, P–19–181,
and P–19–182), and halogenated sodium
alkylbenzoate (P–19–184 and P–19–
187).
CAS Numbers: Not available.
Effective Date of TSCA Order: January
31, 2020.
Basis for TSCA Order: The PMNs
states that the generic (non-confidential)
use will be to monitor oil and gas well
performance (P–19–180, P–19–181, P–
19–182, P–19–184, and P–19–187) and
as well performance tracers (P–19–168,
P–19–169, P–19–171, P–19–172, P–19–
173, P–19–175, P–19–176, P–19–177, P–
19–178, and P–19–179). Based on the
estimated physical/chemical properties
of the PMN substances and comparison
with analogous chemical substances,
EPA has identified concerns for
developmental toxicity and
neurotoxicity for all of the PMN
substances and additionally irritation to
skin, eyes, and respiratory tract for P–
19–168, P–19–169, P–19–171, P–19–
172, P–19–173, P–19–175, P–19–176, P–
19–177, P–19–178, and P–19–179. 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 TSCA
Order requires:
1. No manufacture (including import),
processing, or use of any of the PMN
substances other than for the
confidential use described in each PMN;
2. Submission to EPA of certain
toxicity testing before manufacturing
(including import) beyond the
confidential cumulative production
volumes listed in the Testing Section of
the TSCA Order;
3. Use of personal protective
equipment where there is a potential for
dermal exposure to PMN substances P–
19–168, P–19–169, P–19–171, P–19–
172, P–19–173, P–19–175, P–19–176, P–
19–177, P–19–178, or P–19–179;
4. Use of engineering controls/
processes as specified in the TSCA
Order;
5. Use of a NIOSH-certified respirator
with an APF of at least 10 where there
is a potential for inhalation exposure to
PMN substances P–19–168, P–19–169,
P–19–171, P–19–172, P–19–173, P–19–
175, P–19–176, P–19–177, P–19–178, or
P–19–179 or compliance with a NCEL of
0.0195 mg/m3 as an 8-hour timeweighted average to prevent inhalation
exposure;
6. Establishment and use of a hazard
communication program, including
human health precautionary statements
on each label and in the SDS;
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7. No manufacture or use of PMN
substances P–19–180, P–19–181, P–19–
182, P–19–184, or P–19–187 other than
in liquid formulations; and
8. No manufacture of the PMN
substances P–19–168, P–19–169, P–19–
171, P–19–172, P–19–173, P–19–175, P–
19–176, P–19–177, P–19–178, or P–19–
179 beyond the confidential annual
production volume limit specified in
the TSCA 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 human health effects of the
PMN substances may be potentially
useful in support of a request by the
PMN submitter to modify the TSCA
Order, or if a manufacturer or processor
is considering submitting a SNUN for a
significant new use that will be
designated by this SNUR. EPA has
determined that the results of skin
irritation, eye damage, neurotoxicity,
reproductive/developmental toxicity,
pulmonary effects, and specific target
organ toxicity testing may be potentially
useful to characterize the human health
effects of the PMN substances. Although
the TSCA Order does not require these
tests, the TSCA Order’s restrictions
remain in effect until the TSCA Order
is modified or revoked by EPA based on
submission of this or other relevant
information.
CFR Citations: 40 CFR 721.11541 (P–
19–168), 40 CFR 721.11542 (P–19–169),
40 CFR 721.11543 (P–19–171), 40 CFR
721.11544 (P–19–172), 40 CFR
721.11545 (P–19–173), 40 CFR
721.11546 (P–19–175), 40 CFR
721.11547 (P–19–176), 40 CFR
721.11548 (P–19–177), 40 CFR
721.11549 (P–19–178), 40 CFR
721.11550 (P–19–179), 40 CFR
721.11551 (P–19–180), 40 CFR
721.11552 (P–19–181), 40 CFR
721.11553 (P–19–182), 40 CFR
721.11554 (P–19–184), and 40 CFR
721.11555 (P–19–187).
V. Rationale and Objectives of the
Proposed Rule
A. Rationale
During review of the PMNs submitted
for some of 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
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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.
During review of the other chemical
substances that are the subject of these
proposed SNURs and as further
discussed in Unit IV., EPA identified
certain other circumstances of use
different from the intended conditions
of use identified in the PMNs and
determined that those changes could
result in changes in the type or form of
exposure to the chemical substances
and/or increased exposures to the
chemical substances and/or changes in
the reasonably anticipated manner and
methods of manufacturing, processing,
distribution in commerce, and disposal
of the chemical substances.
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
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
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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 42 of the 45 chemical
substances that are the subject of this
proposed SNUR, and the PMN
submitters are prohibited by the TSCA
Orders from undertaking activities
which would be designated as
significant new uses. The identities of
all 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 October 9,
2020 as the cutoff date for determining
whether the new use is ongoing. The
objective of EPA’s approach is to ensure
that a person cannot defeat a SNUR by
initiating a significant new use before
the effective date of the final rule.
In the unlikely event that a person
began commercial manufacture or
processing of the chemical substances
for a significant new use identified as of
that date would have to cease any such
activity upon the effective date of the
final rule. To resume their activities,
these persons would have to first
comply with all applicable SNUR
notification requirements and wait until
EPA has conducted a review of the
notice, made an appropriate
determination on the notice, and has
taken such actions as are required with
that determination.
Issuance of a SNUR for a chemical
substance does not signify that the
chemical substance is listed on the
TSCA Chemical Substance Inventory
(TSCA Inventory). Guidance on how to
determine if a chemical substance is on
the TSCA Inventory is available on the
internet at https://www.epa.gov/tscainventory.
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
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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 (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 all
SNURs listed here. Descriptions of this
information is provided for
informational purposes. The potentially
useful information identified in Unit IV.
of the proposed rule will be useful to
EPA’s evaluation in the event that
someone submits a SNUN for the
significant new use. Companies who are
considering submitting a SNUN are
encouraged, but not required, to develop
the information on the substance, which
may assist with EPA’s analysis of the
SNUN. 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 on 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 potentially useful
information. EPA encourages dialogue
with Agency representatives to help
determine how best the submitter can
meet both the data needs and the
objective of TSCA section 4(h). To
access the OCSPP test guidelines
referenced in this document
electronically, please go to https://
www.epa.gov/ocspp and select ‘‘Test
Methods and Guidelines.’’ The
Organisation for Economic Co-operation
and Development (OECD) test
guidelines are available from the OECD
Bookshop at https://
www.oecdbookshop.org or SourceOECD
at https://www.sourceoecd.org.
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:
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• 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-toxicsubstances-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 under docket ID number EPA–
HQ–OPPT–2020–0131.
X. Statutory and Executive Order
Reviews
Additional information about these
statutes and Executive Orders can be
found at https://www.epa.gov/lawsregulations-and-executive-orders.
A. Executive Order 12866: Regulatory
Planning and Review and Executive
Order 13563: Improving Regulations
and Regulatory Review
This proposed rule would 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
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part 9, and included on the related
collection instrument or form, if
applicable.
The information collection activities
related to this action have already been
approved by OMB under the PRA under
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
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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 proposed rule is not subject to
Executive Order 13045 (62 FR 19885,
April 23, 1997), because this is not an
economically significant regulatory
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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 proposed rule 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.
Dated: September 14, 2020.
Tala Henry,
Deputy Director, Office of Pollution
Prevention and Toxics.
Therefore, for the reasons stated in the
preamble, it is proposed that 40 CFR
chapter I be amended as follows:
PARTS 721—SIGNIFICANT NEW USES
OF CHEMICAL SUBSTANCES
1. The authority citation for part 721
continues to read as follows:
■
Authority: 15 U.S.C. 2604, 2607, 2613, and
2625(c).
2. Add §§ 721.11401 through
721.11403 and §§ 721.11514 through
721.11555 to subpart E to read as
follows:
■
Subpart E—Significant New Uses for
Specific Chemical Substances
*
*
*
*
*
*
*
*
*
Sec.
*
721.11401 2-Propenoic acid, 2-methyl-,
methyl ester, polymer with
ethenylbenzene, ethyl 2-propenoate, 2oxiranylmethyl 2-methyl-2-propenoate
and 1,2-propanediol mono(2-methyl-2propenoate), reaction products with
diethanolamine, polymers with
substituted-alkyl acrylate, formats (salts)
(generic).
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721.11402 2-Propenoic acid, 2-methyl,
methyl ester, polymer with
ethenylbenzene, ethyl 2-propenoate, 2oxiranylmethyl 2-methyl-2-propenoate
and 1,2-propanediol mono(2-methyl-2propenoate), reaction products with
diethanolamine, polymers with
substituted-alkyl methacrylate, formats
(salts) (generic).
721.11403 2-Propenoic acid, 2-methyl-,
methyl ester, polymer with
ethenylbenzene, ethyl 2-propenoate, 2oxrianylmethyl 2-methyl-2-propenoate,
and 1,2-propaneidol mono(2-methyl-2propenoate), reaction products with
diethanolamine, polymers with alkylene
glycol monoacrylate, formats (salts)
(generic).
*
*
*
*
*
721.11514 Organic sulfonate compound
(generic).
721.11515 Thiophenium, 1-(2,7disubstituted-1-naphthalenyl)tetrahydro, salt with polyfluoro-Npolyfluoroalkylsulfonyl-1alkanesulfonamide (1:1) (generic).
721.11516 Sulfonium, triphenyl-, salt with
2,3-bis(substituted) 5sulfocarbopolycyclic-2,3-carboxylate
derivative (1:1) (generic).
721.11517 Thiophenium, 1-(2,7disubstituted-1-naphthalenyl)tetrahydro, salt with polyfluoro-Npolyfluoroalkylsulfonyl-1alkanesulfonamide (1:1) (generic).
721.11518 Sulfonium, triphenyl-, 5-(alkyl)
fluoropentane derivative (generic).
721.11519 Sulfonium, triphenyl-, salt with
substituted-alkyl 4-substituted-benzoate
(generic).
721.11520 Substituted-triphenylsulfonium,
inner salt (generic).
721.11521 Sulfonium, triphenyl-, salt with
disubstituted-heterocyclic compound
(1:1) (generic).
721.11522 Sulfonium, triphenyl-, salt with
2,4,5-trisubstituted-benzenesulfonate
(1:1) (generic).
721.11523 Substituted heterocyclic onium
compound, salt with 2,2,2-trifluoro-1(sulfomethyl)-1-(trifluoromethyl)ethyl 3[(2-methyl-1-oxo-2-propen-1yl)oxy]tricyclo[3.3.1.13,7]decane-1carboxylate (1:1), polymer with
acenaphthylene, 1-ethenyl-4-[(1ethylcyclopentyl)oxy]benzene and 4ethenylphenol, di-Me 2,2′-(1,2diazenediyl)bis[2-methylpropanoate]initiated (generic).
721.11524 Substituted heterocyclic onium
compound, salt with 2,2,2-trifluoro-1(sulfomethyl)-1-(trifluoromethyl)ethyl 3[(2-methyl-1-oxo-2-propen-1yl)oxy]tricyclo[3.3.1.13,7]decane-1carboxylate (1:1), polymer with
acenaphthylene 1-ethenyl-4-[[1-(1methylethyl)cyclopentyl]oxy]benzene
and 4-ethenylphenol, di-Me 2,2′-(1,2diazenediyl)bis[2-methylpropanoate]initiated (generic).
721.11525 Dibenzothiophenium, aryl
substituted trifluoro-hydroxy(triheterosubstitutedalkyl)alkanoate (1:1)
(generic).
721.11526 Substituted heterocyclic onium
compound, salt with 1-
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(difluorosulfomethyl)-2,2,2-trifluoroethyl
3-[(2-methyl-1-oxo-2-propen-1yl)oxy]tricyclo[3.3.1.13,7]decane-1carboxylate (1:1), polymer with 3ethenylphenol, 1-(1methylethyl)cyclopentyl 2-methyl-2propenoate and 1-(7oxabicyclo[2.2.1]hept-2-yl)cyclopentyl 2methyl-2-propenoate, di-Me 2,2′-(1,2diazenediyl)bis[2-methylpropenoate]initiated (generic).
721.11527 Sulfonium, triphenyl-, trifluorohydroxy(triheterosubstitutedalkyl)alkanoate (1:1)
(generic).
721.11528 Heterotrisubstituted-bile acid, 1(difluorosulfomethyl)-2,2,2-trifluoroethyl
ester, ion(1-), (5)-, triphenylsulfonium
(1:1) (generic).
721.11529 Aromatic sulfonium tricyclo
fluoroalkyl sulfonic acid salt (generic)
721.11530 Substituted,
(alkylaromatic)diaromatic salt with
trihalo[(trihaloalkyl)substituted]substituted
alkaneamide (generic).
721.11531 Triarylsulfonium substituted
oxatricycloalkyloxycarbonyl dihalo
alkane sulfonate (generic).
721.11532 Substituted triarylsulfonium
carbopolycyclic heteromonocyclic dihalo
sulfoacetate (generic).
721.11533 Substituted triarylsulfonium
substituted carbopolycyclic carboxylate
(generic).
721.11534 Sulfonium,
bis(dihalocarbomonocycle)
carbomonocycle, salt with substituted
heteropolycycle dihalo sulfoalkanoate
(1:1) (generic).
721.11535 Heteropolycycle, alkylaromatic-,
salt with dihalo-substituted alkyl
carbopolycycle carboxylate (generic).
721.11536 Sulfonium, triaryl-, salt with
polyhalo-4-sulfoalkyl polycarbocyclic
alkane-1-carboxylate (1:1) (generic).
721.11537 Sulfonium,
bis(dihalocarbomonocycle)
carbomonocycle, salt with dihalo
substituted alkyl carbopolycyclic
carboxylate (1:1) (generic).
721.11538 Sulfonium,
bis(dihalocarbomonocycle)
carbomonocycle, substituted
carbomonocyclic ester (generic).
721.11539 Heteropolycycle, aromatic-, salt
with dihalo-substituted alkyl
carbopolycycle carboxylate (1:1)
(generic).
721.11540 Triarylsulfonium
alkylestersulfonate (generic).
721.11541 Halogenated alkylbenzoic acid
(generic).
721.11542 Halogenated alkylbenzoic acid
(generic).
721.11543 Halogenated benzoic acid
(generic).
721.11544 Halogenated benzoic acid
(generic).
721.11545 Halogenated benzoic acid
(generic).
721.11546 Halogenated alkylbenzoic acid
(generic).
721.11547 Halogenated alkylbenzoic acid
(generic).
721.11548 Halogenated alkylbenzoic acid
(generic).
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721.11549 Halogenated alkylbenzoic acid
(generic).
721.11550 Halogenated alkylbenzoic acid
(generic).
721.11551 Halogenated sodium benzoate
(generic).
721.11552 Halogenated sodium benzoate
(generic).
721.11553 Halogenated sodium benzoate
(generic).
721.11554 Halogenated sodium
alkylbenzoate (generic).
721.11555 Halogenated sodium
alkylbenzoate (generic).
*
*
*
*
*
§ 721.11401 2-Propenoic acid, 2-methyl-,
methyl ester, polymer with ethenylbenzene,
ethyl 2-propenoate, 2-oxiranylmethyl 2methyl-2-propenoate and 1,2-propanediol
mono(2-methyl-2-propenoate), reaction
products with diethanolamine, polymers
with substituted-alkyl acrylate, formats
(salts) (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as 2-propenoic acid, 2methyl-, methyl ester, polymer with
ethenylbenzene, ethyl 2-propenoate, 2oxiranylmethyl 2-methyl-2-propenoate
and 1,2-propanediol mono(2-methyl-2propenoate), reaction products with
diethanolamine, polymers with
substituted-alkyl acrylate, formats (salts)
(PMN P–18–241) 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 § 721.80(j).
(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
§ 721.125(a) through (c), and (i) are
applicable to manufacturers and
processors of these substances.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
§ 721.11402 2-Propenoic acid, 2-methyl,
methyl ester, polymer with ethenylbenzene,
ethyl 2-propenoate, 2-oxiranylmethyl 2methyl-2-propenoate and 1,2-propanediol
mono(2-methyl-2-propenoate), reaction
products with diethanolamine, polymers
with substituted-alkyl methacrylate, formats
(salts) (generic).
(a) Chemical substance and
significant new uses subject to reporting.
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(1) The chemical substance generically
identified as 2-propenoic acid, 2methyl, methyl ester, polymer with
ethenylbenzene, ethyl 2-propenoate, 2oxiranylmethyl 2-methyl-2-propenoate
and 1,2-propanediol mono(2-methyl-2propenoate), reaction products with
diethanolamine, polymers with
substituted-alkyl methacrylate, formats
(salts) (PMN P–18–244) 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 § 721.80(j).
(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
§ 721.125(a) through (c), and (i) are
applicable to manufacturers and
processors of these substances.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
§ 721.11403 2-Propenoic acid, 2-methyl-,
methyl ester, polymer with ethenylbenzene,
ethyl 2-propenoate, 2-oxrianylmethyl 2methyl-2-propenoate, and 1,2-propaneidol
mono(2-methyl-2-propenoate), reaction
products with diethanolamine, polymers
with alkylene glycol monoacrylate, formats
(salts) (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as 2-propenoic acid, 2methyl-, methyl ester, polymer with
ethenylbenzene, ethyl 2-propenoate, 2oxrianylmethyl 2-methyl-2-propenoate,
and 1,2-propaneidol mono(2-methyl-2propenoate), reaction products with
diethanolamine, polymers with alkylene
glycol monoacrylate, formats (salts)
(PMN P–18–245) 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 § 721.80(j).
(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
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§ 721.125(a) through (c), and (i) are
applicable to manufacturers and
processors of these substances.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
*
*
*
*
*
§ 721.11514
(generic).
Organic sulfonate compound
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as organic sulfonate
compound (PMN P–16–539) 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 PMN
substance after they have been
completely reacted or adhered (during
the photolithographic process) onto a
semiconductor water 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
§ 721.63(a)(1), (2)(i) and (iii), and (3),
and (c). When determining which
persons are reasonably likely to be
exposed as required for § 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 § 721.72(a)
through (d), (e), (g)(1)(i), (2)(i) through
(iii), and (v), (3)(i) and (ii), and (5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1)(i), required
human health hazard statements
include acute toxicity, skin
sensitization, serious eye damage,
specific target organ toxicity,
neurotoxicity, genetic toxicity, and
reproductive toxicity.
(iii) Industrial, commercial, and
consumer use. Requirements as
specified in § 721.80(f), (k), and (t). It is
a significant new use to import the PMN
substance other than in solution, unless
in sealed containers weighing 5
kilograms or less. It is a significant new
use to process the PMN substance in
any way that generates a dust, mist, or
aerosol in a non-enclosed process. It is
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a significant new use to manufacture the
PMN substance longer than 18 months.
(b) Specific requirements. The
provision of subpart A of this part apply
to this section except as modified by
this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitations or revocation of
certain modification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(iii) of this section.
§ 721.11515 Thiophenium, 1-(2,7disubstituted-1-naphthalenyl)tetrahydro-,
salt with polyfluoro-Npolyfluoroalkylsulfonyl-1alkanesulfonamide (1:1) (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as thiophenium, 1-(2,7disubstituted-1naphthalenyl)tetrahydro-, salt with
polyfluoro-N-polyfluoroalkylsulfonyl-1alkanesulfonamide (1:1) (PMN P–18–
157) 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 PMN
substance after they have been
completely reacted or adhered (during
the photolithographic process) onto a
semiconductor water 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
§ 721.63(a)(1), (2)(i) and (iii), and (3),
and (c). When determining which
persons are reasonably likely to be
exposed as required for § 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 § 721.72(a)
through (d), (e), (g)(1)(i), (2)(i) through
(iii), and (v), (3)(i) and (ii), and (5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1)(i), required
human health hazard statements
include acute toxicity, skin
sensitization, serious eye damage,
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specific target organ toxicity,
neurotoxicity, genetic toxicity, and
reproductive toxicity.
(iii) Industrial, commercial, and
consumer use. Requirements as
specified in § 721.80(f), (k), and (t). It is
a significant new use to import the PMN
substance other than in solution, unless
in sealed containers weighing 5
kilograms or less. It is a significant new
use to process the PMN substance in
any way that generates a dust, mist, or
aerosol in a non-enclosed process. It is
a significant new use to manufacture the
PMN substance longer than 18 months.
(b) Specific requirements. The
provision of subpart A of this part apply
to this section except as modified by
this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitations or revocation of
certain modification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(iii) of this section.
§ 721.11516 Sulfonium, triphenyl-, salt with
2,3-bis(substituted) 5-sulfocarbopolycyclic2,3-carboxylate derivative (1:1) (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as sulfonium, triphenyl-, salt
with 2,3-bis(substituted) 5sulfocarbopolycyclic-2,3-carboxylate
derivative (1:1) (PMN P–18–158), 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 PMN
substance after they have been
completely reacted or adhered (during
the photolithographic process) onto a
semiconductor water 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
§ 721.63(a)(1), (2)(i) and (iii), and (3),
and (c). When determining which
persons are reasonably likely to be
exposed as required for § 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.
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(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (d), (e), (g)(1)(i), (2)(i) through
(iii), and (v), (3)(i) and (ii), and (5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1)(i), required
human health hazard statements
include acute toxicity, skin
sensitization, serious eye damage,
specific target organ toxicity,
neurotoxicity, genetic toxicity, and
reproductive toxicity.
(iii) Industrial, commercial, and
consumer use. Requirements as
specified in § 721.80(f), (k), and (t). It is
a significant new use to import the PMN
substance other than in solution, unless
in sealed containers weighing 5
kilograms or less. It is a significant new
use to process the PMN substance in
any way that generates a dust, mist, or
aerosol in a non-enclosed process. It is
a significant new use to manufacture the
PMN substance longer than 18 months.
(b) Specific requirements. The
provision of subpart A of this part apply
to this section except as modified by
this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitations or revocation of
certain modification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(iii) of this section.
§ 721.11517 Thiophenium, 1-(2,7disubstituted-1-naphthalenyl)tetrahydro-,
salt with polyfluoro-Npolyfluoroalkylsulfonyl-1alkanesulfonamide (1:1) (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as thiophenium, 1-(2,7disubstituted-1naphthalenyl)tetrahydro-, salt with
polyfluoro-N-polyfluoroalkylsulfonyl-1alkanesulfonamide (1:1) (PMN P–18–
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 PMN
substance after they have been
completely reacted or adhered (during
the photolithographic process) onto a
semiconductor water surface or similar
manufactured article used in the
production of semiconductor
technologies.
(2) The significant new uses are:
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(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (2)(i) and (iii), and (3),
and (c). When determining which
persons are reasonably likely to be
exposed as required for § 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 § 721.72(a)
through (d), (e), (g)(1)(i), (2)(i) through
(iii), and (v), (3)(i) and (ii), and (5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1)(i), required
human health hazard statements
include acute toxicity, skin
sensitization, serious eye damage,
specific target organ toxicity,
neurotoxicity, genetic toxicity, and
reproductive toxicity.
(iii) Industrial, commercial, and
consumer use. Requirements as
specified in § 721.80(f), (k), and (t). It is
a significant new use to import the PMN
substance other than in solution, unless
in sealed containers weighing 5
kilograms or less. It is a significant new
use to process the PMN substance in
any way that generates a dust, mist, or
aerosol in a non-enclosed process. It is
a significant new use to manufacture the
PMN substance longer than 18 months.
(b) Specific requirements. The
provision of subpart A of this part apply
to this section except as modified by
this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitations or revocation of
certain modification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(iii) of this section.
§ 721.11518 Sulfonium, triphenyl-, 5-(alkyl)
fluoropentane derivative (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as sulfonium, triphenyl-, 5(alkyl) fluoropentane derivative (PMN
P–19–33) is subject to reporting under
this section for the significant new uses
described in paragraph (a)(2) of this
section. The requirements of this section
do not apply to quantities of the PMN
substance after they have been
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completely reacted or adhered (during
the photolithographic process) onto a
semiconductor water 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
§ 721.63(a)(1), (2)(i) and (iii), and (3),
and (c). When determining which
persons are reasonably likely to be
exposed as required for § 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 § 721.72(a)
through (d), (e), (g)(1)(i), (2)(i) through
(iii), and (v), (3)(i) and (ii), and (5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1)(i), required
human health hazard statements
include acute toxicity, skin
sensitization, serious eye damage,
specific target organ toxicity,
neurotoxicity, genetic toxicity, and
reproductive toxicity.
(iii) Industrial, commercial, and
consumer use. Requirements as
specified in § 721.80(f), (k), and (t). It is
a significant new use to import the PMN
substance other than in solution, unless
in sealed containers weighing 5
kilograms or less. It is a significant new
use to process the PMN substance in
any way that generates a dust, mist, or
aerosol in a non-enclosed process. It is
a significant new use to manufacture the
PMN substance longer than 18 months.
(b) Specific requirements. The
provision of subpart A of this part apply
to this section except as modified by
this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitations or revocation of
certain modification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(iii) of this section.
§ 721.11519 Sulfonium, triphenyl-, salt with
substituted-alkyl 4-substituted-benzoate
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
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identified as sulfonium, triphenyl-, salt
with substituted-alkyl 4-substitutedbenzoate (PMN P–17–178) is subject to
reporting under this section for the
significant new use 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 the photolithographic
process) onto a semiconductor water
surface or similar manufactured article
used in the production of
semiconductor technologies.
(2) The significant new use is:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (2)(i) and (iii), and (3),
and (c). When determining which
persons are reasonably likely to be
exposed as required for § 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 § 721.72(a)
through (d), and (e), (g)(1)(i), (2)(i)
through (iii), and (v), (3)(i) and (ii), and
(5). For purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1)(i), required
human health hazard statements
include acute toxicity, skin
sensitization, serious eye damage,
specific target organ toxicity,
neurotoxicity, genetic toxicity, and
reproductive toxicity.
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(f), (k), and (t). It is
a significant new use to import the PMN
substance other than in solution, unless
in sealed containers weighing 5
kilograms or less. It is a significant new
use to process the PMN substance in
any way that generates a dust, mist, or
aerosol in a non-enclosed process. It is
a significant new use to manufacture the
PMN substance longer than 18 months.
(b) Specific requirements. The
provision of subpart A of this part apply
to this section except as modified by
this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitations or revocation of
certain modification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
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of § 721.1725(b)(1) apply to paragraph
(a)(2)(iii) of this section.
§ 721.11520 Substitutedtriphenylsulfonium, inner salt (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as substitutedtriphenylsulfonium, inner salt (PMN P–
18–13) is subject to reporting under this
section for the significant new use
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
the photolithographic process) onto a
semiconductor water surface or similar
manufactured article used in the
production of semiconductor
technologies.
(2) The significant new use is:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (2)(i) and (iii), and (3),
and (c). When determining which
persons are reasonably likely to be
exposed as required for § 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 § 721.72(a)
through (d), (e), (g)(1)(i), (2)(i) through
(iii), and (v), (3)(i) and (ii), and (5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1)(i), required
human health hazard statements
include acute toxicity, skin
sensitization, serious eye damage,
specific target organ toxicity,
neurotoxicity, genetic toxicity, and
reproductive toxicity.
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(f), (k), and (t). It is
a significant new use to import the PMN
substance other than in solution, unless
in sealed containers weighing 5
kilograms or less. It is a significant new
use to process the PMN substance in
any way that generates a dust, mist, or
aerosol in a non-enclosed process. It is
a significant new use to manufacture the
PMN substance longer than 18 months.
(b) Specific requirements. The
provision of subpart A of this part apply
to this section except as modified by
this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
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manufacturers and processors of this
substance.
(2) Limitations or revocation of
certain modification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(iii) of this section.
§ 721.11521 Sulfonium, triphenyl-, salt with
disubstituted-heterocyclic compound (1:1)
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as sulfonium, triphenyl-, salt
with disubstituted-heterocyclic
compound (1:1) (PMN P–18–14) is
subject to reporting under this section
for the significant new use 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 the photolithographic
process) onto a semiconductor water
surface or similar manufactured article
used in the production of
semiconductor technologies.
(2) The significant new use is:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (2)(i) and (iii), and (3),
and (c). When determining which
persons are reasonably likely to be
exposed as required for § 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 § 721.72(a)
through (d), (e), (g)(1)(i), (2)(i) through
(iii), and (v), (3)(i) and (ii), and (5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1)(i), required
human health hazard statements
include acute toxicity, skin
sensitization, serious eye damage,
specific target organ toxicity,
neurotoxicity, genetic toxicity, and
reproductive toxicity.
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(f), (k), and (t). It is
a significant new use to import the PMN
substance other than in solution, unless
in sealed containers weighing 5
kilograms or less. It is a significant new
use to process the PMN substance in
any way that generates a dust, mist, or
aerosol in a non-enclosed process. It is
PO 00000
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Fmt 4701
Sfmt 4702
a significant new use to manufacture the
PMN substance longer than 18 months.
(b) Specific requirements. The
provision of subpart A of this part apply
to this section except as modified by
this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitations or revocation of
certain modification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(iii) of this section.
§ 721.11522 Sulfonium, triphenyl-, salt with
2,4,5-trisubstituted-benzenesulfonate (1:1)
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as sulfonium, triphenyl-, salt
with 2,4,5-trisubstitutedbenzenesulfonate (1:1) (PMN P–18–37)
is subject to reporting under this section
for the significant new use 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 the photolithographic
process) onto a semiconductor water
surface or similar manufactured article
used in the production of
semiconductor technologies.
(2) The significant new use is:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (2)(i) and (iii), and (3),
and (c). When determining which
persons are reasonably likely to be
exposed as required for § 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 § 721.72(a)
through (d), (e), (g)(1)(i), (2)(i) through
(iii), and (v), (3)(i) and (ii), and (5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1)(i), required
human health hazard statements
include acute toxicity, skin
sensitization, serious eye damage,
specific target organ toxicity,
neurotoxicity, genetic toxicity, and
reproductive toxicity.
(iii) Industrial, commercial, and
consumer activities. Requirements as
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specified in § 721.80(f), (k), and (t). It is
a significant new use to import the PMN
substance other than in solution, unless
in sealed containers weighing 5
kilograms or less. It is a significant new
use to process the PMN substance in
any way that generates a dust, mist, or
aerosol in a non-enclosed process. It is
a significant new use to manufacture the
PMN substance longer than 18 months.
(b) Specific requirements. The
provision of subpart A of this part apply
to this section except as modified by
this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitations or revocation of
certain modification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(iii) of this section.
§ 721.11523 Substituted heterocyclic
onium compound, salt with 2,2,2-trifluoro-1(sulfomethyl)-1-(trifluoromethyl)ethyl 3-[(2methyl-1-oxo-2-propen-1yl)oxy]tricyclo[3.3.1.13,7]decane-1carboxylate (1:1), polymer with
acenaphthylene, 1-ethenyl-4-[(1ethylcyclopentyl)oxy]benzene and 4ethenylphenol, di-Me 2,2′-(1,2diazenediyl)bis[2-methylpropanoate]initiated (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as substituted heterocyclic
onium compound, salt with 2,2,2trifluoro-1-(sulfomethyl)-1(trifluoromethyl)ethyl 3-[(2-methyl-1oxo-2-propen-1yl)oxy]tricyclo[3.3.1.13,7]decane-1carboxylate (1:1), polymer with
acenaphthylene, 1-ethenyl-4-[(1ethylcyclopentyl)oxy]benzene and 4ethenylphenol, di-Me 2,2′-(1,2diazenediyl)bis[2-methylpropanoate]initiated (PMN P–19–78) is subject to
reporting under this section for the
significant new use 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 the photolithographic
process) onto a semiconductor water
surface or similar manufactured article
used in the production of
semiconductor technologies.
(2) The significant new use is:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (2)(i) and (iii), and (3),
and (c). When determining which
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persons are reasonably likely to be
exposed as required for § 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 § 721.72(a)
through (d), (e), (g)(1)(i), (2)(i) through
(iii), and (v), (3)(i) and (ii), and (5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1)(i), required
human health hazard statements
include acute toxicity, skin
sensitization, serious eye damage,
specific target organ toxicity,
neurotoxicity, genetic toxicity, and
reproductive toxicity.
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(f), (k), and (t). It is
a significant new use to import the PMN
substance other than in solution, unless
in sealed containers weighing 5
kilograms or less. It is a significant new
use to process the PMN substance in
any way that generates a dust, mist, or
aerosol in a non-enclosed process. It is
a significant new use to manufacture the
PMN substance longer than 18 months.
(b) Specific requirements. The
provision of subpart A of this part apply
to this section except as modified by
this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitations or revocation of
certain modification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(iii) of this section.
§ 721.11524 Substituted heterocyclic
onium compound, salt with 2,2,2-trifluoro-1(sulfomethyl)-1-(trifluoromethyl)ethyl 3-[(2methyl-1-oxo-2-propen-1yl)oxy]tricyclo[3.3.1.13,7]decane-1carboxylate (1:1), polymer with
acenaphthylene 1-ethenyl-4-[[1-(1methylethyl)cyclopentyl]oxy]benzene and 4ethenylphenol, di-Me 2,2′-(1,2diazenediyl)bis[2-methylpropanoate]initiated (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as substituted heterocyclic
onium compound, salt with 2,2,2trifluoro-1-(sulfomethyl)-1(trifluoromethyl)ethyl 3-[(2-methyl-1-
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64293
oxo-2-propen-1yl)oxy]tricyclo[3.3.1.13,7]decane-1carboxylate (1:1), polymer with
acenaphthylene 1-ethenyl-4-[[1-(1methylethyl)cyclopentyl]oxy]benzene
and 4-ethenylphenol, di-Me 2,2′-(1,2diazenediyl)bis[2-methylpropanoate]initiated (PMN P–19–79) is subject to
reporting under this section for the
significant new use 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 the photolithographic
process) onto a semiconductor water
surface or similar manufactured article
used in the production of
semiconductor technologies.
(2) The significant new use is:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (2)(i) and (iii), and (3),
and (c). When determining which
persons are reasonably likely to be
exposed as required for § 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 § 721.72(a)
through (d), (e), (g)(1)(i), (2)(i) through
(iii), and (v), (3)(i) and (ii), and (5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1)(i), required
human health hazard statements
include acute toxicity, skin
sensitization, serious eye damage,
specific target organ toxicity,
neurotoxicity, genetic toxicity, and
reproductive toxicity.
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(f), (k), and (t). It is
a significant new use to import the PMN
substance other than in solution, unless
in sealed containers weighing 5
kilograms or less. It is a significant new
use to process the PMN substance in
any way that generates a dust, mist, or
aerosol in a non-enclosed process. It is
a significant new use to manufacture the
PMN substance longer than 18 months.
(b) Specific requirements. The
provision of subpart A of this part apply
to this section except as modified by
this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitations or revocation of
certain modification requirements. The
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Federal Register / Vol. 85, No. 197 / Friday, October 9, 2020 / Proposed Rules
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(iii) of this section.
§ 721.11525 Dibenzothiophenium, aryl
substituted trifluoro-hydroxy(triheterosubstitutedalkyl)alkanoate (1:1)
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as dibenzothiophenium, aryl
substituted trifluoro-hydroxy(triheterosubstitutedalkyl)alkanoate
(1:1) (PMN P–19–111) is subject to
reporting under this section for the
significant new use 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 the photolithographic
process) onto a semiconductor water
surface or similar manufactured article
used in the production of
semiconductor technologies.
(2) The significant new use is:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (2)(i) and (iii), and (3),
and (c). When determining which
persons are reasonably likely to be
exposed as required for § 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 § 721.72(a)
through (d), (e), (g)(1)(i), (2)(i) through
(iii), and (v), (3)(i) and (ii), and (5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1)(i), required
human health hazard statements
include acute toxicity, skin
sensitization, serious eye damage,
specific target organ toxicity,
neurotoxicity, genetic toxicity, and
reproductive toxicity.
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(f), (k), and (t). It is
a significant new use to import the PMN
substance other than in solution, unless
in sealed containers weighing 5
kilograms or less. It is a significant new
use to process the PMN substance in
any way that generates a dust, mist, or
aerosol in a non-enclosed process. It is
a significant new use to manufacture the
PMN substance longer than 18 months.
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(b) Specific requirements. The
provision of subpart A of this part apply
to this section except as modified by
this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitations or revocation of
certain modification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(iii) of this section.
§ 721.11526 Substituted heterocyclic
onium compound, salt with 1(difluorosulfomethyl)-2,2,2-trifluoroethyl 3[(2-methyl-1-oxo-2-propen-1yl)oxy]tricyclo[3.3.1.13,7]decane-1carboxylate (1:1), polymer with 3ethenylphenol, 1-(1-methylethyl)cyclopentyl
2-methyl-2-propenoate and 1-(7oxabicyclo[2.2.1]hept-2-yl)cyclopentyl 2methyl-2-propenoate, di-Me 2,2′-(1,2diazenediyl)bis[2-methylpropenoate]initiated (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as substituted heterocyclic
onium compound, salt with 1(difluorosulfomethyl)-2,2,2trifluoroethyl 3-[(2-methyl-1-oxo-2propen-1yl)oxy]tricyclo[3.3.1.13,7]decane-1carboxylate (1:1), polymer with 3ethenylphenol, 1-(1methylethyl)cyclopentyl 2-methyl-2propenoate and 1-(7oxabicyclo[2.2.1]hept-2-yl)cyclopentyl
2-methyl-2-propenoate, di-Me 2,2′-(1,2diazenediyl)bis[2-methylpropenoate]initiated (PMN P–19–112) is subject to
reporting under this section for the
significant new use 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 the photolithographic
process) onto a semiconductor water
surface or similar manufactured article
used in the production of
semiconductor technologies.
(2) The significant new use is:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (2)(i) and (iii), and (3),
and (c). When determining which
persons are reasonably likely to be
exposed as required for § 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)
PO 00000
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shall be considered and implemented to
prevent exposure, where feasible.
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (d), (e), (g)(1)(i), (2)(i) through
(iii), and (v), (3)(i) and (ii), and (5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1)(i), required
human health hazard statements
include acute toxicity, skin
sensitization, serious eye damage,
specific target organ toxicity,
neurotoxicity, genetic toxicity, and
reproductive toxicity.
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(f), (k), and (t). It is
a significant new use to import the PMN
substance other than in solution, unless
in sealed containers weighing 5
kilograms or less. It is a significant new
use to process the PMN substance in
any way that generates a dust, mist, or
aerosol in a non-enclosed process. It is
a significant new use to manufacture the
PMN substance longer than 18 months.
(b) Specific requirements. The
provision of subpart A of this part apply
to this section except as modified by
this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitations or revocation of
certain modification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(iii) of this section.
§ 721.11527 Sulfonium, triphenyl-,
trifluoro-hydroxy(triheterosubstitutedalkyl)alkanoate (1:1)
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as sulfonium, triphenyl-,
trifluoro-hydroxy(triheterosubstitutedalkyl)alkanoate
(1:1) (PMN P–19–114) is subject to
reporting under this section for the
significant new use 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 the photolithographic
process) onto a semiconductor water
surface or similar manufactured article
used in the production of
semiconductor technologies.
(2) The significant new use is:
(i) Protection in the workplace.
Requirements as specified in
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§ 721.63(a)(1), (2)(i) and (iii), and (3),
and (c). When determining which
persons are reasonably likely to be
exposed as required for § 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 § 721.72(a)
through (d), (e), (g)(1)(i), (2)(i) through
(iii), and (v), (3)(i) and (ii), and (5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1)(i), required
human health hazard statements
include acute toxicity, skin
sensitization, serious eye damage,
specific target organ toxicity,
neurotoxicity, genetic toxicity, and
reproductive toxicity.
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(f), (k), and (t). It is
a significant new use to import the PMN
substance other than in solution, unless
in sealed containers weighing 5
kilograms or less. It is a significant new
use to process the PMN substance in
any way that generates a dust, mist, or
aerosol in a non-enclosed process. It is
a significant new use to manufacture the
PMN substance longer than 18 months.
(b) Specific requirements. The
provision of subpart A of this part apply
to this section except as modified by
this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitations or revocation of
certain modification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(iii) of this section.
§ 721.11528 Heterotrisubstituted-bile acid,
1-(difluorosulfomethyl)-2,2,2-trifluoroethyl
ester, ion(1-), (5)-, triphenylsulfonium (1:1)
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as heterotrisubstituted-bile
acid, 1-(difluorosulfomethyl)-2,2,2trifluoroethyl ester, ion(1-), (5)-,
triphenylsulfonium (1:1) (PMN P–19–
133) is subject to reporting under this
section for the significant new use
described in paragraph (a)(2) of this
section. The requirements of this section
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do not apply to quantities of the
substance after they have been
completely reacted or adhered (during
the photolithographic process) onto a
semiconductor water surface or similar
manufactured article used in the
production of semiconductor
technologies.
(2) The significant new use is:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (2)(i) and (iii), and (3),
and (c). When determining which
persons are reasonably likely to be
exposed as required for § 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 § 721.72(a)
through (d), (e), (g)(1)(i), (2)(i) through
(iii), and (v), (3)(i) and (ii), and (5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1)(i), required
human health hazard statements
include acute toxicity, skin
sensitization, serious eye damage,
specific target organ toxicity,
neurotoxicity, genetic toxicity, and
reproductive toxicity.
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(f), (k), and (t). It is
a significant new use to import the PMN
substance other than in solution, unless
in sealed containers weighing 5
kilograms or less. It is a significant new
use to process the PMN substance in
any way that generates a dust, mist, or
aerosol in a non-enclosed process. It is
a significant new use to manufacture the
PMN substance longer than 18 months.
(b) Specific requirements. The
provision of subpart A of this part apply
to this section except as modified by
this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitations or revocation of
certain modification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(iii) of this section.
§ 721.11529 Aromatic sulfonium tricyclo
fluoroalkyl sulfonic acid salt (generic).
(a) Chemical substance and
significant new uses subject to reporting.
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64295
(1) The chemical substance generically
identified as aromatic sulfonium
tricyclo fluoroalkyl sulfonic acid salt
(PMN P–18–16) 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
PMN substance after they have been
completely reacted or adhered (during
the photolithographic process) onto a
semiconductor water 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
§ 721.63(a)(1), (2)(i) and (iii), and (3),
and (c). When determining which
persons are reasonably likely to be
exposed as required for § 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 § 721.72(a)
through (d), (e), (g)(1)(i), (2)(i) through
(iii), and (v), (3)(i) and (ii), and (5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1)(i), required
human health hazard statements
include acute toxicity, skin
sensitization, serious eye damage,
specific target organ toxicity,
neurotoxicity, genetic toxicity, and
reproductive toxicity.
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(f), (k), and (t). It is
a significant new use to import the PMN
substance other than in solution, unless
in sealed containers weighing 5
kilograms or less. It is a significant new
use to use or process the PMN substance
in any way that generates a dust, mist,
or aerosol in a non-enclosed process. It
is a significant new use to manufacture
the PMN substance longer than 18
months.
(b) Specific requirements. The
provision of subpart A of this part apply
to this section except as modified by
this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitations or revocation of
certain modification requirements. The
provisions of § 721.185 apply to this
section.
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(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(iii) of this section.
§ 721.11530 Substituted,
(alkylaromatic)diaromatic salt with trihalo[(trihaloalkyl)substituted]substituted
alkaneamide (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as substituted,
(alkylaromatic)diaromatic salt with
trihalo[(trihaloalkyl)substituted]substituted
alkaneamide (PMN P–18–297) is subject
to reporting under this section for the
significant new use 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 the photolithographic
process) onto a semiconductor water
surface or similar manufactured article
used in the production of
semiconductor technologies.
(2) The significant new use is:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (2)(i) and (iii), and (3),
and (c). When determining which
persons are reasonably likely to be
exposed as required for § 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 § 721.72(a)
through (d), (e), (g)(1)(i), (2)(i) through
(iii), and (v), (3)(i) and (ii), and (5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1)(i), required
human health hazard statements
include acute toxicity, skin
sensitization, serious eye damage,
specific target organ toxicity,
neurotoxicity, genetic toxicity, and
reproductive toxicity.
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(f), (k), and (t). It is
a significant new use to import the PMN
substance other than in solution, unless
in sealed containers weighing 5
kilograms or less. It is a significant new
use to process the PMN substance in
any way that generates a dust, mist, or
aerosol in a non-enclosed process. It is
a significant new use to manufacture the
PMN substance longer than 18 months.
(b) Specific requirements. The
provision of subpart A of this part apply
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to this section except as modified by
this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitations or revocation of
certain modification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(iii) of this section.
§ 721.11531 Triarylsulfonium substituted
oxatricycloalkyloxycarbonyl dihalo alkane
sulfonate (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as triarylsulfonium
substituted oxatricycloalkyloxycarbonyl
dihalo alkane sulfonate (PMN P–18–
311) is subject to reporting under this
section for the significant new use
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
the photolithographic process) onto a
semiconductor water surface or similar
manufactured article used in the
production of semiconductor
technologies.
(2) The significant new use is:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (2)(i) and (iii), and (3),
and (c). When determining which
persons are reasonably likely to be
exposed as required for § 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 § 721.72(a)
through (d), (e), (g)(1)(i), (2)(i) through
(iii), and (v), (3)(i) and (ii), and (5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1)(i), required
human health hazard statements
include acute toxicity, skin
sensitization, serious eye damage,
specific target organ toxicity,
neurotoxicity, genetic toxicity, and
reproductive toxicity.
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(f), (k), and (t). It is
a significant new use to import the PMN
substance other than in solution, unless
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in sealed containers weighing 5
kilograms or less. It is a significant new
use to process the PMN substance in
any way that generates a dust, mist, or
aerosol in a non-enclosed process. It is
a significant new use to manufacture the
PMN substance longer than 18 months.
(b) Specific requirements. The
provision of subpart A of this part apply
to this section except as modified by
this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitations or revocation of
certain modification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(iii) of this section.
§ 721.11532 Substituted triarylsulfonium
carbopolycyclic heteromonocyclic dihalo
sulfoacetate (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as substituted
triarylsulfonium carbopolycyclic
heteromonocyclic dihalo sulfoacetate
(PMN P–18–314) is subject to reporting
under this section for the significant
new use 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
the photolithographic process) onto a
semiconductor water surface or similar
manufactured article used in the
production of semiconductor
technologies.
(2) The significant new use is:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (2)(i) and (iii), and (3),
and (c). When determining which
persons are reasonably likely to be
exposed as required for § 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 § 721.72(a)
through (d), (e), (g)(1)(i), (2)(i) through
(iii), and (v), (3)(i) and (ii), and (5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1)(i), required
human health hazard statements
include acute toxicity, skin
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sensitization, serious eye damage,
specific target organ toxicity,
neurotoxicity, genetic toxicity, and
reproductive toxicity.
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(f), (k), and (t). It is
a significant new use to import the PMN
substance other than in solution, unless
in sealed containers weighing 5
kilograms or less. It is a significant new
use to process the PMN substance in
any way that generates a dust, mist, or
aerosol in a non-enclosed process. It is
a significant new use to manufacture the
PMN substance longer than 18 months.
(b) Specific requirements. The
provision of subpart A of this part apply
to this section except as modified by
this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitations or revocation of
certain modification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(iii) of this section.
§ 721.11533 Substituted triarylsulfonium
substituted carbopolycyclic carboxylate
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as substituted
triarylsulfonium substituted
carbopolycyclic carboxylate (PMN P–
18–315) is subject to reporting under
this section for the significant new use
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
the photolithographic process) onto a
semiconductor water surface or similar
manufactured article used in the
production of semiconductor
technologies.
(2) The significant new use is:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (2)(i) and (iii), and (3),
and (c). When determining which
persons are reasonably likely to be
exposed as required for § 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.
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(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (d), (e), (g)(1)(i), (2)(i) through
(iii), and (v), (3)(i) and (ii), and (5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1)(i), required
human health hazard statements
include acute toxicity, skin
sensitization, serious eye damage,
specific target organ toxicity,
neurotoxicity, genetic toxicity, and
reproductive toxicity.
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(f), (k), and (t). It is
a significant new use to import the PMN
substance other than in solution, unless
in sealed containers weighing 5
kilograms or less. It is a significant new
use to process the PMN substance in
any way that generates a dust, mist, or
aerosol in a non-enclosed process. It is
a significant new use to manufacture the
PMN substance longer than 18 months.
(b) Specific requirements. The
provision of subpart A of this part apply
to this section except as modified by
this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitations or revocation of
certain modification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(iii) of this section.
§ 721.11534 Sulfonium,
bis(dihalocarbomonocycle)
carbomonocycle, salt with substituted
heteropolycycle dihalo sulfoalkanoate (1:1)
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as sulfonium,
bis(dihalocarbomonocycle)
carbomonocycle, salt with substituted
heteropolycycle dihalo sulfoalkanoate
(1:1) (PMN P–18–304) is subject to
reporting under this section for the
significant new use 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 the photolithographic
process) onto a semiconductor water
surface or similar manufactured article
used in the production of
semiconductor technologies.
(2) The significant new use is:
(i) Protection in the workplace.
Requirements as specified in
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64297
§ 721.63(a)(1), (2)(i) and (iii), and (3),
and (c). When determining which
persons are reasonably likely to be
exposed as required for § 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 § 721.72(a)
through (d), (e), (g)(1)(i), (2)(i) through
(iii), and (v), (3)(i) and (ii), and (5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1)(i), required
human health hazard statements
include acute toxicity, skin
sensitization, serious eye damage,
specific target organ toxicity,
neurotoxicity, genetic toxicity, and
reproductive toxicity.
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(f), (k), and (t). It is
a significant new use to import the PMN
substance other than in solution, unless
in sealed containers weighing 5
kilograms or less. It is a significant new
use to process the PMN substance in
any way that generates a dust, mist, or
aerosol in a non-enclosed process. It is
a significant new use to manufacture the
PMN substance longer than 18 months.
(b) Specific requirements. The
provision of subpart A of this part apply
to this section except as modified by
this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitations or revocation of
certain modification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(iii) of this section.
§ 721.11535 Heteropolycycle,
alkylaromatic-, salt with dihalo-substituted
alkyl carbopolycycle carboxylate (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified heteropolycycle,
alkylaromatic-, salt with dihalosubstituted alkyl carbopolycycle
carboxylate (PMN P–18–316) is subject
to reporting under this section for the
significant new use described in
paragraph (a)(2) of this section. The
requirements of this section do not
apply to quantities of the substance after
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they have been completely reacted or
adhered (during the photolithographic
process) onto a semiconductor water
surface or similar manufactured article
used in the production of
semiconductor technologies.
(2) The significant new use is:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (2)(i) and (iii), and (3),
and (c). When determining which
persons are reasonably likely to be
exposed as required for § 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 § 721.72(a)
through (d), (e), (g)(1)(i), (2)(i) through
(iii), and (v), (3)(i) and (ii), and (5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1)(i), required
human health hazard statements
include acute toxicity, skin
sensitization, serious eye damage,
specific target organ toxicity,
neurotoxicity, genetic toxicity, and
reproductive toxicity.
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(f), (k), and (t). It is
a significant new use to import the PMN
substance other than in solution, unless
in sealed containers weighing 5
kilograms or less. It is a significant new
use to process the PMN substance in
any way that generates a dust, mist, or
aerosol in a non-enclosed process. It is
a significant new use to manufacture the
PMN substance longer than 18 months.
(b) Specific requirements. The
provision of subpart A of this part apply
to this section except as modified by
this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitations or revocation of
certain modification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(iii) of this section.
§ 721.11536 Sulfonium, triaryl-, salt with
polyhalo-4-sulfoalkyl polycarbocyclic
alkane-1-carboxylate (1:1) (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
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identified as sulfonium, triaryl-, salt
with polyhalo-4-sulfoalkyl
polycarbocyclic alkane-1-carboxylate
(1:1) (PMN P–18–338) is subject to
reporting under this section for the
significant new use 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 the photolithographic
process) onto a semiconductor water
surface or similar manufactured article
used in the production of
semiconductor technologies.
(2) The significant new use is:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (2)(i) and (iii), and (3),
and (c). When determining which
persons are reasonably likely to be
exposed as required for § 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 § 721.72(a)
through (d), (e), (g)(1)(i), (2)(i) through
(iii), and (v), (3)(i) and (ii), and (5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1)(i), required
human health hazard statements
include acute toxicity, skin
sensitization, serious eye damage,
specific target organ toxicity,
neurotoxicity, genetic toxicity, and
reproductive toxicity.
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(f), (k), and (t). It is
a significant new use to import the PMN
substance other than in solution, unless
in sealed containers weighing 5
kilograms or less. It is a significant new
use to process the PMN substance in
any way that generates a dust, mist, or
aerosol in a non-enclosed process. It is
a significant new use to manufacture the
PMN substance longer than 18 months.
(b) Specific requirements. The
provision of subpart A of this part apply
to this section except as modified by
this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitations or revocation of
certain modification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
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of § 721.1725(b)(1) apply to paragraph
(a)(2)(iii) of this section.
§ 721.11537 Sulfonium,
bis(dihalocarbomonocycle)
carbomonocycle, salt with dihalo
substituted alkyl carbopolycyclic
carboxylate (1:1) (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as sulfonium,
bis(dihalocarbomonocycle)
carbomonocycle, salt with dihalo
substituted alkyl carbopolycyclic
carboxylate (1:1) (PMN P–19–76) is
subject to reporting under this section
for the significant new use 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 the photolithographic
process) onto a semiconductor water
surface or similar manufactured article
used in the production of
semiconductor technologies.
(2) The significant new use is:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (2)(i) and (iii), and (3),
and (c). When determining which
persons are reasonably likely to be
exposed as required for § 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 § 721.72(a)
through (d), (e), (g)(1)(i), (2)(i) through
(iii), and (v), (3)(i) and (ii), and (5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1)(i), required
human health hazard statements
include acute toxicity, skin
sensitization, serious eye damage,
specific target organ toxicity,
neurotoxicity, genetic toxicity, and
reproductive toxicity.
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(f), (k), and (t). It is
a significant new use to import the PMN
substance other than in solution, unless
in sealed containers weighing 5
kilograms or less. It is a significant new
use to process the PMN substance in
any way that generates a dust, mist, or
aerosol in a non-enclosed process. It is
a significant new use to manufacture the
PMN substance longer than 18 months.
(b) Specific requirements. The
provision of subpart A of this part apply
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to this section except as modified by
this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitations or revocation of
certain modification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(iii) of this section.
§ 721.11538 Sulfonium,
bis(dihalocarbomonocycle)
carbomonocycle, substituted
carbomonocyclic ester (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as sulfonium,
bis(dihalocarbomonocycle)
carbomonocycle, substituted
carbomonocyclic ester (PMN P–19–115)
is subject to reporting under this section
for the significant new use 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 the photolithographic
process) onto a semiconductor water
surface or similar manufactured article
used in the production of
semiconductor technologies.
(2) The significant new use is:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (2)(i) and (iii), and (3),
and (c). When determining which
persons are reasonably likely to be
exposed as required for § 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 § 721.72(a)
through (d), (e), (g)(1)(i), (2)(i) through
(iii), and (v), (3)(i) and (ii), and (5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1)(i), required
human health hazard statements
include acute toxicity, skin
sensitization, serious eye damage,
specific target organ toxicity,
neurotoxicity, genetic toxicity, and
reproductive toxicity.
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(f), (k), and (t). It is
a significant new use to import the PMN
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substance other than in solution, unless
in sealed containers weighing 5
kilograms or less. It is a significant new
use to process the PMN substance in
any way that generates a dust, mist, or
aerosol in a non-enclosed process. It is
a significant new use to manufacture the
PMN substance longer than 18 months.
(b) Specific requirements. The
provision of subpart A of this part apply
to this section except as modified by
this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitations or revocation of
certain modification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(iii) of this section.
§ 721.11539 Heteropolycycle, aromatic-,
salt with dihalo-substituted alkyl
carbopolycycle carboxylate (1:1) (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as heteropolycycle, aromatic, salt with dihalo-substituted alkyl
carbopolycycle carboxylate (1:1) (PMN
P–19–142) is subject to reporting under
this section for the significant new use
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
the photolithographic process) onto a
semiconductor water surface or similar
manufactured article used in the
production of semiconductor
technologies.
(2) The significant new use is:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (2)(i) and (iii), and (3),
and (c). When determining which
persons are reasonably likely to be
exposed as required for § 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 § 721.72(a)
through (d), (e), (g)(1)(i), (2)(i) through
(iii), and (v), (3)(i) and (ii), and (5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1)(i), required
human health hazard statements
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64299
include acute toxicity, skin
sensitization, serious eye damage,
specific target organ toxicity,
neurotoxicity, genetic toxicity, and
reproductive toxicity.
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(f), (k), and (t). It is
a significant new use to import the PMN
substance other than in solution, unless
in sealed containers weighing 5
kilograms or less. It is a significant new
use to process the PMN substance in
any way that generates a dust, mist, or
aerosol in a non-enclosed process. It is
a significant new use to manufacture the
PMN substance longer than 18 months.
(b) Specific requirements. The
provision of subpart A of this part apply
to this section except as modified by
this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitations or revocation of
certain modification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(iii) of this section.
§ 721.11540 Triarylsulfonium
alkylestersulfonate (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as triarylsulfonium
alkylestersulfonate (PMN P–19–166) 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 PMN
substance after they have been
completely reacted or adhered (during
the photolithographic process) onto a
semiconductor water 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
§ 721.63(a)(1), (2)(i) and (iii), and (3),
and (c). When determining which
persons are reasonably likely to be
exposed as required for § 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.
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(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (d), (e), (g)(1)(i), (2)(i) through
(iii), and (v), (3)(i) and (ii), and (5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1)(i), required
human health hazard statements
include acute toxicity, skin
sensitization, serious eye damage,
specific target organ toxicity,
neurotoxicity, genetic toxicity, and
reproductive toxicity.
(iii) Industrial, commercial, and
consumer use. Requirements as
specified in § 721.80(f), (k), and (t). It is
a significant new use to import the PMN
substance other than in solution, unless
in sealed containers weighing 5
kilograms or less. It is a significant new
use to use or process the PMN substance
in any way that generates a dust, mist,
or aerosol in a non-enclosed process. It
is a significant new use to manufacture
the PMN substance longer than 18
months.
(b) Specific requirements. The
provision of subpart A of this part apply
to this section except as modified by
this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitations or revocation of
certain modification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(iii) of this section.
§ 721.11541
(generic).
Halogenated alkylbenzoic acid
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as halogenated alkylbenzoic
acid (PMN P–19–168) is subject to
reporting under this section for the
significant new use described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (2)(i) and (iii), and (iv),
and (3) through (6), (b), and (c). When
determining which persons are
reasonably likely to be exposed as
required for § 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
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Jkt 253001
purposes of § 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
§ 721.63(a)(6), the airborne form(s) of
the substance include particulate, gas/
vapor (all substances in the gas form),
combination gas/vapor and particulate
(gas and liquid/solid physical states are
present; a good example is paint spray
mist, which contains both liquid
droplets and vapor). For purposes of
§ 721.63(b), the concentration is set at
1.0%.
(A) As an alternative to the respirator
requirements in paragraph (a)(2)(i) of
this section, a manufacturer or processor
may choose to follow the new chemical
exposure limit (NCEL) provision listed
in the TSCA section 5(e) consent order
for this substance. The NCEL is 0.0195
mg/m3 as an 8-hour time weighted
average. Persons who wish to pursue
NCELs as an alternative to § 721.63
respirator requirements may request to
do so under § 721.30. Persons who
§ 721.30 requests to use the NCELs
approach that are approved by EPA will
be required to follow NCELs provisions
comparable to those contained in the
corresponding TSCA section 5(e)
consent order.
(B) [Reserved]
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (e), (f), (g)(1)(ii) through (iv),
(vi), and (ix) (eye and skin irritation),
(g)(2)(i) through (iv), and (v), and (5).
For purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1)(i), required
human health hazard statements
include acute toxicity, skin
sensitization, serious eye damage,
specific target organ toxicity,
neurotoxicity, genetic toxicity, and
reproductive toxicity. For purposes of
§ 721.72(g)(2)(iv), use respiratory
protection or maintain workplace
airborne concentrations at or below an
8-hour time-weighted average of 0.0195
mg/m3. 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 § 721.80(k), (q), and (t). It is
a significant new use to manufacture or
process the PMN substance without
including the engineering controls/
processes described in the TSCA section
5(e) consent order for the substance.
(b) Specific requirements. The
provision of subpart A of this part apply
to this section except as modified by
this paragraph (b).
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(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitations or revocation of
certain modification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(iii) of this section.
§ 721.11542
(generic).
Halogenated alkylbenzoic acid
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as halogenated alkylbenzoic
acid (PMN P–19–169) is subject to
reporting under this section for the
significant new use described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (2)(i) and (iii), and (iv),
(3) through (6), (b), and (c). When
determining which persons are
reasonably likely to be exposed as
required for § 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 § 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
§ 721.63(a)(6), the airborne form(s) of
the substance include particulate, gas/
vapor (all substances in the gas form),
combination gas/vapor and particulate
(gas and liquid/solid physical states are
present; a good example is paint spray
mist, which contains both liquid
droplets and vapor). For purposes of
§ 721.63(b), the concentration is set at
1.0%.
(A) As an alternative to the respirator
requirements in paragraph (a)(2)(i) of
this section, a manufacturer or processor
may choose to follow the new chemical
exposure limit (NCEL) provision listed
in the TSCA section 5(e) consent order
for this substance. The NCEL is 0.0195
mg/m3 as an 8-hour time weighted
average. Persons who wish to pursue
NCELs as an alternative to § 721.63
respirator requirements may request to
do so under § 721.30. Persons who
§ 721.30 requests to use the NCELs
approach that are approved by EPA will
be required to follow NCELs provisions
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comparable to those contained in the
corresponding TSCA section 5(e)
consent order.
(B) [Reserved]
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (e), (f), (g)(1)(ii) through (iv),
(vi), and (ix)(eye and skin irritation),
(g)(2)(i) through (v), and (5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1)(i), required
human health hazard statements
include acute toxicity, skin
sensitization, serious eye damage,
specific target organ toxicity,
neurotoxicity, genetic toxicity, and
reproductive toxicity. For purposes of
§ 721.72(g)(2)(iv), use respiratory
protection or maintain workplace
airborne concentrations at or below an
8-hour time-weighted average of 0.0195
mg/m3. 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 § 721.80(k), (q), and (t). It is
a significant new use to manufacture or
process the PMN substance without
including the engineering controls/
processes described in the TSCA section
5(e) consent order for the substance.
(b) Specific requirements. The
provision of subpart A of this part apply
to this section except as modified by
this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitations or revocation of
certain modification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(iii) of this section.
§ 721.11543
(generic).
Halogenated benzoic acid
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as halogenated benzoic acid
(PMN P–19–171) is subject to reporting
under this section for the significant
new use described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (2)(i) and (iii), and (iv),
(3) through (6), and (b), and (c). When
determining which persons are
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Jkt 253001
reasonably likely to be exposed as
required for § 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 § 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
§ 721.63(a)(6), the airborne form(s) of
the substance include particulate, gas/
vapor (all substances in the gas form),
combination gas/vapor and particulate
(gas and liquid/solid physical states are
present; a good example is paint spray
mist, which contains both liquid
droplets and vapor). For purposes of
§ 721.63(b), the concentration is set at
1.0%.
(A) As an alternative to the respirator
requirements in paragraph (a)(2)(i) of
this section, a manufacturer or processor
may choose to follow the new chemical
exposure limit (NCEL) provision listed
in the TSCA section 5(e) consent order
for this substance. The NCEL is 0.0195
mg/m3 as an 8-hour time weighted
average. Persons who wish to pursue
NCELs as an alternative to § 721.63
respirator requirements may request to
do so under § 721.30. Persons who
§ 721.30 requests to use the NCELs
approach that are approved by EPA will
be required to follow NCELs provisions
comparable to those contained in the
corresponding TSCA section 5(e)
consent order.
(B) [Reserved]
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (e), (f), (g)(1)(ii) through (iv),
(vi), and (ix)(eye and skin irritation),
(g)(2)(i) through (v), and (5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1)(i), required
human health hazard statements
include acute toxicity, skin
sensitization, serious eye damage,
specific target organ toxicity,
neurotoxicity, genetic toxicity, and
reproductive toxicity. For purposes of
§ 721.72(g)(2)(iv), use respiratory
protection or maintain workplace
airborne concentrations at or below an
8-hour time-weighted average of 0.0195
mg/m3. 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 § 721.80(k), (q), and (t). It is
PO 00000
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64301
a significant new use to manufacture or
process the PMN substance without
including the engineering controls/
processes described in the TSCA section
5(e) consent order for the substance.
(b) Specific requirements. The
provision of subpart A of this part apply
to this section except as modified by
this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitations or revocation of
certain modification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(iii) of this section.
§ 721.11544
(generic).
Halogenated benzoic acid
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as halogenated benzoic acid
(PMN P–19–172) is subject to reporting
under this section for the significant
new use described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (2)(i) and (iii), and (iv),
and (3) through (6), and (b), and (c).
When determining which persons are
reasonably likely to be exposed as
required for § 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 § 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
§ 721.63(a)(6), the airborne form(s) of
the substance include particulate, gas/
vapor (all substances in the gas form),
combination gas/vapor and particulate
(gas and liquid/solid physical states are
present; a good example is paint spray
mist, which contains both liquid
droplets and vapor). For purposes of
§ 721.63(b), the concentration is set at
1.0%.
(A) As an alternative to the respirator
requirements in paragraph (a)(2)(i) of
this section, a manufacturer or processor
may choose to follow the new chemical
exposure limit (NCEL) provision listed
in the TSCA section 5(e) consent order
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for this substance. The NCEL is 0.0195
mg/m3 as an 8-hour time weighted
average. Persons who wish to pursue
NCELs as an alternative to § 721.63
respirator requirements may request to
do so under § 721.30. Persons who
§ 721.30 requests to use the NCELs
approach that are approved by EPA will
be required to follow NCELs provisions
comparable to those contained in the
corresponding TSCA section 5(e)
consent order.
(B) [Reserved]
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (e), (f), (g)(1)(ii) through (iv),
(vi), (ix)(eye and skin irritation), (g)(2)(i)
through (v), and (5). For purposes of
§ 721.72(e), the concentration is set at
1.0%. For purposes of § 721.72(g)(1)(i),
required human health hazard
statements include acute toxicity, skin
sensitization, serious eye damage,
specific target organ toxicity,
neurotoxicity, genetic toxicity, and
reproductive toxicity. For purposes of
§ 721.72(g)(2)(iv), use respiratory
protection or maintain workplace
airborne concentrations at or below an
8-hour time-weighted average of 0.0195
mg/m3. 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 § 721.80(k), (q), and (t). It is
a significant new use to manufacture or
process the PMN substance without
including the engineering controls/
processes described in the TSCA section
5(e) consent order for the substance.
(b) Specific requirements. The
provision of subpart A of this part apply
to this section except as modified by
this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitations or revocation of
certain modification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(iii) of this section.
§ 721.11545
(generic).
Halogenated benzoic acid
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as halogenated benzoic acid
(PMN P–19–173) is subject to reporting
under this section for the significant
VerDate Sep<11>2014
20:46 Oct 08, 2020
Jkt 253001
new use described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (2)(i) and (iii), and (iv),
and (3) through (6), and (b), and (c).
When determining which persons are
reasonably likely to be exposed as
required for § 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 § 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
§ 721.63(a)(6), the airborne form(s) of
the substance include particulate, gas/
vapor (all substances in the gas form),
combination gas/vapor and particulate
(gas and liquid/solid physical states are
present; a good example is paint spray
mist, which contains both liquid
droplets and vapor). For purposes of
§ 721.63(b), the concentration is set at
1.0%.
(A) As an alternative to the respirator
requirements in paragraph (a)(2)(i) of
this section, a manufacturer or processor
may choose to follow the new chemical
exposure limit (NCEL) provision listed
in the TSCA section 5(e) consent order
for this substance. The NCEL is 0.0195
mg/m3 as an 8-hour time weighted
average. Persons who wish to pursue
NCELs as an alternative to § 721.63
respirator requirements may request to
do so under § 721.30. Persons who
§ 721.30 requests to use the NCELs
approach that are approved by EPA will
be required to follow NCELs provisions
comparable to those contained in the
corresponding TSCA section 5(e)
consent order.
(B) [Reserved]
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (e), (f), (g)(1)(ii) through (iv),
(vi), and (ix)(eye and skin irritation),
(g)(2)(i) through (v), and (5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1)(i), required
human health hazard statements
include acute toxicity, skin
sensitization, serious eye damage,
specific target organ toxicity,
neurotoxicity, genetic toxicity, and
reproductive toxicity. For purposes of
§ 721.72(g)(2)(iv), use respiratory
protection or maintain workplace
airborne concentrations at or below an
8-hour time-weighted average of 0.0195
PO 00000
Frm 00024
Fmt 4701
Sfmt 4702
mg/m3. 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 § 721.80(k), (q), and (t). It is
a significant new use to manufacture or
process the PMN substance without
including the engineering controls/
processes described in the TSCA section
5(e) consent order for the substance.
(b) Specific requirements. The
provision of subpart A of this part apply
to this section except as modified by
this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitations or revocation of
certain modification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(iii) of this section.
§ 721.11546
(generic).
Halogenated alkylbenzoic acid
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as halogenated alkylbenzoic
acid (PMN P–19–175) is subject to
reporting under this section for the
significant new use described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (2)(i) and (iii), and (iv),
and (3) through (6), and (b), and (c).
When determining which persons are
reasonably likely to be exposed as
required for § 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 § 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
§ 721.63(a)(6), the airborne form(s) of
the substance include particulate, gas/
vapor (all substances in the gas form),
combination gas/vapor and particulate
(gas and liquid/solid physical states are
present; a good example is paint spray
mist, which contains both liquid
droplets and vapor). For purposes of
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§ 721.63(b), the concentration is set at
1.0%.
(A) As an alternative to the respirator
requirements in paragraph (a)(2)(i) of
this section, a manufacturer or processor
may choose to follow the new chemical
exposure limit (NCEL) provision listed
in the TSCA section 5(e) consent order
for this substance. The NCEL is 0.0195
mg/m3 as an 8-hour time weighted
average. Persons who wish to pursue
NCELs as an alternative to § 721.63
respirator requirements may request to
do so under § 721.30. Persons who
§ 721.30 requests to use the NCELs
approach that are approved by EPA will
be required to follow NCELs provisions
comparable to those contained in the
corresponding TSCA section 5(e)
consent order.
(B) [Reserved]
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (e), (f), (g)(1)(ii) through (iv),
(vi), and (ix) (eye and skin irritation),
(g)(2)(i) through (v), and (5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1)(i), required
human health hazard statements
include acute toxicity, skin
sensitization, serious eye damage,
specific target organ toxicity,
neurotoxicity, genetic toxicity, and
reproductive toxicity. For purposes of
§ 721.72(g)(2)(iv), use respiratory
protection or maintain workplace
airborne concentrations at or below an
8-hour time-weighted average of 0.0195
mg/m3. 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 § 721.80(k), (q), and (t). It is
a significant new use to manufacture or
process the PMN substance without
including the engineering controls/
processes described in the TSCA section
5(e) consent order for the substance.
(b) Specific requirements. The
provision of subpart A of this part apply
to this section except as modified by
this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitations or revocation of
certain modification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(iii) of this section.
VerDate Sep<11>2014
20:46 Oct 08, 2020
Jkt 253001
§ 721.11547
(generic).
Halogenated alkylbenzoic acid
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as halogenated alkylbenzoic
acid (PMN P–19–176) is subject to
reporting under this section for the
significant new use described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (2)(i) and (iii), and (iv),
and (3) through (6), and (b), and (c).
When determining which persons are
reasonably likely to be exposed as
required for § 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 § 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
§ 721.63(a)(6), the airborne form(s) of
the substance include particulate, gas/
vapor (all substances in the gas form),
combination gas/vapor and particulate
(gas and liquid/solid physical states are
present; a good example is paint spray
mist, which contains both liquid
droplets and vapor). For purposes of
§ 721.63(b), the concentration is set at
1.0%.
(A) As an alternative to the respirator
requirements in paragraph (a)(2)(i) of
this section, a manufacturer or processor
may choose to follow the new chemical
exposure limit (NCEL) provision listed
in the TSCA section 5(e) consent order
for this substance. The NCEL is 0.0195
mg/m3 as an 8-hour time weighted
average. Persons who wish to pursue
NCELs as an alternative to § 721.63
respirator requirements may request to
do so under § 721.30. Persons who
§ 721.30 requests to use the NCELs
approach that are approved by EPA will
be required to follow NCELs provisions
comparable to those contained in the
corresponding TSCA section 5(e)
consent order.
(B) [Reserved]
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (e), (f), (g)(1)(ii) through (iv),
(vi), and (ix) (eye and skin irritation),
(g)(2)(i) through (v), and (5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1)(i), required
human health hazard statements
include acute toxicity, skin
PO 00000
Frm 00025
Fmt 4701
Sfmt 4702
64303
sensitization, serious eye damage,
specific target organ toxicity,
neurotoxicity, genetic toxicity, and
reproductive toxicity. For purposes of
§ 721.72(g)(2)(iv), use respiratory
protection or maintain workplace
airborne concentrations at or below an
8-hour time-weighted average of 0.0195
mg/m3. 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 § 721.80(k), (q), and (t). It is
a significant new use to manufacture or
process the PMN substance without
including the engineering controls/
processes described in the TSCA section
5(e) consent order for the substance.
(b) Specific requirements. The
provision of subpart A of this part apply
to this section except as modified by
this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitations or revocation of
certain modification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(iii) of this section.
§ 721.11548
(generic).
Halogenated alkylbenzoic acid
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as halogenated alkylbenzoic
acid (PMN P–19–177) is subject to
reporting under this section for the
significant new use described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (2)(i) and (iii), and (iv),
and (3) through (6), and (b), and (c).
When determining which persons are
reasonably likely to be exposed as
required for § 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 § 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
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§ 721.63(a)(6), the airborne form(s) of
the substance include particulate, gas/
vapor (all substances in the gas form),
combination gas/vapor and particulate
(gas and liquid/solid physical states are
present; a good example is paint spray
mist, which contains both liquid
droplets and vapor). For purposes of
§ 721.63(b), the concentration is set at
1.0%.
(A) As an alternative to the respirator
requirements in paragraph (a)(2)(i) of
this section, a manufacturer or processor
may choose to follow the new chemical
exposure limit (NCEL) provision listed
in the TSCA section 5(e) consent order
for this substance. The NCEL is 0.0195
mg/m3 as an 8-hour time weighted
average. Persons who wish to pursue
NCELs as an alternative to § 721.63
respirator requirements may request to
do so under § 721.30. Persons who
§ 721.30 requests to use the NCELs
approach that are approved by EPA will
be required to follow NCELs provisions
comparable to those contained in the
corresponding TSCA section 5(e)
consent order.
(B) [Reserved]
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (e), (f), (g)(1)(ii) through (iv),
(vi), and (ix) (eye and skin irritation),
(g)(2)(i) through (v), and (5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1)(i), required
human health hazard statements
include acute toxicity, skin
sensitization, serious eye damage,
specific target organ toxicity,
neurotoxicity, genetic toxicity, and
reproductive toxicity. For purposes of
§ 721.72(g)(2)(iv), use respiratory
protection or maintain workplace
airborne concentrations at or below an
8-hour time-weighted average of 0.0195
mg/m3. 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 § 721.80(k), (q), and (t). It is
a significant new use to manufacture or
process the PMN substance without
including the engineering controls/
processes described in the TSCA section
5(e) consent order for the substance.
(b) Specific requirements. The
provision of subpart A of this part apply
to this section except as modified by
this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
VerDate Sep<11>2014
20:46 Oct 08, 2020
Jkt 253001
(2) Limitations or revocation of
certain modification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(iii) of this section.
§ 721.11549
(generic).
Halogenated alkylbenzoic acid
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as halogenated alkylbenzoic
acid (PMN P–19–178) is subject to
reporting under this section for the
significant new use described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (2)(i) and (iii), and (iv),
and (3) through (6), (b), and (c). When
determining which persons are
reasonably likely to be exposed as
required for § 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 § 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
§ 721.63(a)(6), the airborne form(s) of
the substance include particulate, gas/
vapor (all substances in the gas form),
combination gas/vapor and particulate
(gas and liquid/solid physical states are
present; a good example is paint spray
mist, which contains both liquid
droplets and vapor). For purposes of
§ 721.63(b), the concentration is set at
1.0%.
(A) As an alternative to the respirator
requirements in paragraph (a)(2)(i) of
this section, a manufacturer or processor
may choose to follow the new chemical
exposure limit (NCEL) provision listed
in the TSCA section 5(e) consent order
for this substance. The NCEL is 0.0195
mg/m3 as an 8-hour time weighted
average. Persons who wish to pursue
NCELs as an alternative to § 721.63
respirator requirements may request to
do so under § 721.30. Persons who
§ 721.30 requests to use the NCELs
approach that are approved by EPA will
be required to follow NCELs provisions
comparable to those contained in the
corresponding TSCA section 5(e)
consent order.
(B) [Reserved]
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Frm 00026
Fmt 4701
Sfmt 4702
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (e), (f), (g)(1)(ii) through (iv),
(vi), and (ix) (eye and skin irritation),
(g)(2)(i) through (v), and (5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1)(i), required
human health hazard statements
include acute toxicity, skin
sensitization, serious eye damage,
specific target organ toxicity,
neurotoxicity, genetic toxicity, and
reproductive toxicity. For purposes of
§ 721.72(g)(2)(iv), use respiratory
protection or maintain workplace
airborne concentrations at or below an
8-hour time-weighted average of 0.0195
mg/m3. 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 § 721.80(k), (q), and (t). It is
a significant new use to manufacture or
process the PMN substance without
including the engineering controls/
processes described in the TSCA section
5(e) consent order for the substance.
(b) Specific requirements. The
provision of subpart A of this part apply
to this section except as modified by
this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitations or revocation of
certain modification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(iii) of this section.
§ 721.11550
(generic).
Halogenated alkylbenzoic acid
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as halogenated alkylbenzoic
acid (PMN P–19–179) is subject to
reporting under this section for the
significant new use described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (2)(i) and (iii), and (iv),
and (3) through (6), and (b), and (c).
When determining which persons are
reasonably likely to be exposed as
required for § 721.63(a)(1) and (a)(4),
engineering control measures (e.g.,
enclosure or confinement of the
E:\FR\FM\09OCP2.SGM
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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 § 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
§ 721.63(a)(6), the airborne form(s) of
the substance include particulate, gas/
vapor (all substances in the gas form),
combination gas/vapor and particulate
(gas and liquid/solid physical states are
present; a good example is paint spray
mist, which contains both liquid
droplets and vapor). For purposes of
§ 721.63(b), the concentration is set at
1.0%.
(A) As an alternative to the respirator
requirements in paragraph (a)(2)(i) of
this section, a manufacturer or processor
may choose to follow the new chemical
exposure limit (NCEL) provision listed
in the TSCA section 5(e) consent order
for this substance. The NCEL is 0.0195
mg/m3 as an 8-hour time weighted
average. Persons who wish to pursue
NCELs as an alternative to § 721.63
respirator requirements may request to
do so under § 721.30. Persons who
§ 721.30 requests to use the NCELs
approach that are approved by EPA will
be required to follow NCELs provisions
comparable to those contained in the
corresponding TSCA section 5(e)
consent order.
(B) [Reserved]
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (e), (f), (g)(1)(ii) through (iv),
(vi), and (ix) (eye and skin irritation),
(g)(2)(i) through (v), and (5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1)(i), required
human health hazard statements
include acute toxicity, skin
sensitization, serious eye damage,
specific target organ toxicity,
neurotoxicity, genetic toxicity, and
reproductive toxicity. For purposes of
§ 721.72(g)(2)(iv), use respiratory
protection or maintain workplace
airborne concentrations at or below an
8-hour time-weighted average of 0.0195
mg/m3. 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 § 721.80(k), (q), and (t). It is
a significant new use to manufacture or
process the PMN substance without
including the engineering controls/
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processes described in the TSCA section
5(e) consent order for the substance.
(b) Specific requirements. The
provision of subpart A of this part apply
to this section except as modified by
this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitations or revocation of
certain modification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(iii) of this section.
§ 721.11551
(generic).
Halogenated sodium benzoate
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as halogenated sodium
benzoate (PMN P–19–180) is subject to
reporting under this section for the
significant new use described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Hazard communication.
Requirements as specified in § 721.72(a)
through (e), (f), (g)(1)(ii) through (iv),
(vi), and (ix) (eye and skin irritation),
(g)(2)(i) through (iii), and (5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1)(i), required
human health hazard statements
include acute toxicity, skin
sensitization, serious eye damage,
specific target organ toxicity,
neurotoxicity, genetic toxicity, and
reproductive toxicity. Alternative
hazard and warning statements that
meet the criteria of the Globally
Harmonized System and OSHA Hazard
Communication Standard may be used.
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k) and (q). It is a
significant new use to manufacture or
process the PMN substance without
including the engineering controls/
processes described in the TSCA section
5(e) consent order for the substance. It
is a significant new use to manufacture
or use the PMN substance other than in
liquid formulations.
(b) Specific requirements. The
provision of subpart A of this part apply
to this section except as modified by
this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c) and (f) through
(i) are applicable to manufacturers and
processors of this substance.
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(2) Limitations or revocation of
certain modification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(ii) of this section.
§ 721.11552
(generic).
Halogenated sodium benzoate
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as halogenated sodium
benzoate (PMN P–19–181) is subject to
reporting under this section for the
significant new use described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Hazard communication.
Requirements as specified in § 721.72(a)
through (e), (f), (g)(1)(ii) through (iv),
(vi), and (ix) (eye and skin irritation),
(g)(2)(i) through (iii), and (5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1)(i), required
human health hazard statements
include acute toxicity, skin
sensitization, serious eye damage,
specific target organ toxicity,
neurotoxicity, genetic toxicity, and
reproductive toxicity. Alternative
hazard and warning statements that
meet the criteria of the Globally
Harmonized System and OSHA Hazard
Communication Standard may be used.
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k) and (q). It is a
significant new use to manufacture or
process the PMN substance without
including the engineering controls/
processes described in the TSCA section
5(e) consent order for the substance. It
is a significant new use to manufacture
or use the PMN substance other than in
liquid formulations.
(b) Specific requirements. The
provision of subpart A of this part apply
to this section except as modified by
this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c) and (f) through
(i) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain modification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(ii) of this section.
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§ 721.11553
(generic).
Federal Register / Vol. 85, No. 197 / Friday, October 9, 2020 / Proposed Rules
Halogenated sodium benzoate
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as halogenated sodium
benzoate (PMN P–19–182) is subject to
reporting under this section for the
significant new use described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Hazard communication.
Requirements as specified in § 721.72(a)
through (e), (f), (g)(1)(ii) through (iv),
(vi), and (ix) (eye and skin irritation),
(g)(2)(i) through (iii), and (5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1)(i), required
human health hazard statements
include acute toxicity, skin
sensitization, serious eye damage,
specific target organ toxicity,
neurotoxicity, genetic toxicity, and
reproductive toxicity. Alternative
hazard and warning statements that
meet the criteria of the Globally
Harmonized System and OSHA Hazard
Communication Standard may be used.
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k) and (q). It is a
significant new use to manufacture or
process the PMN substance without
including the engineering controls/
processes described in the TSCA section
5(e) consent order for the substance. It
is a significant new use to manufacture
or use the PMN substance other than in
liquid formulations.
(b) Specific requirements. The
provision of subpart A of this part apply
to this section except as modified by
this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c) and (f) through
(i) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain modification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(ii) of this section.
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§ 721.11554 Halogenated sodium
alkylbenzoate (generic).
§ 721.11555 Halogenated sodium
alkylbenzoate (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as halogenated sodium
alkylbenzoate (PMN P–19–184) is
subject to reporting under this section
for the significant new use described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Hazard communication.
Requirements as specified in § 721.72(a)
through (e), (f), (g)(1)(ii) through (iv),
(vi), and (ix) (eye and skin irritation),
(g)(2)(i) through (iii), and (5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1)(i), required
human health hazard statements
include acute toxicity, skin
sensitization, serious eye damage,
specific target organ toxicity,
neurotoxicity, genetic toxicity, and
reproductive toxicity. Alternative
hazard and warning statements that
meet the criteria of the Globally
Harmonized System and OSHA Hazard
Communication Standard may be used.
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k) and (q). It is a
significant new use to manufacture or
process the PMN substance without
including the engineering controls/
processes described in the TSCA section
5(e) consent order for the substance. It
is a significant new use to manufacture
or use the PMN substance other than in
liquid formulations.
(b) Specific requirements. The
provision of subpart A of this part apply
to this section except as modified by
this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c) and (f) through
(i) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain modification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(ii) of this section.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as halogenated sodium
alkylbenzoate (PMN P–19–187) is
subject to reporting under this section
for the significant new use described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Hazard communication.
Requirements as specified in § 721.72(a)
through (e), (f), (g)(1)(ii) through (iv),
(vi), and (ix) (eye and skin irritation),
(g)(2)(i) through (iii), and (5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1)(i), required
human health hazard statements
include acute toxicity, skin
sensitization, serious eye damage,
specific target organ toxicity,
neurotoxicity, genetic toxicity, and
reproductive toxicity. Alternative
hazard and warning statements that
meet the criteria of the Globally
Harmonized System and OSHA Hazard
Communication Standard may be used.
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k) and (q). It is a
significant new use to manufacture or
process the PMN substance without
including the engineering controls/
processes described in the TSCA section
5(e) consent order for the substance. It
is a significant new use to manufacture
or use the PMN substance other than in
liquid formulations.
(b) Specific requirements. The
provision of subpart A of this part apply
to this section except as modified by
this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c) and (f) through
(i) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain modification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(ii) of this section.
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]]>Agencies
[Federal Register Volume 85, Number 197 (Friday, October 9, 2020)]
[Proposed Rules]
[Pages 64280-64306]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-21471]
[[Page 64279]]
Vol. 85
Friday,
No. 197
October 9, 2020
Part III
Environmental Protection Agency
-----------------------------------------------------------------------
40 CFR PART 721
Significant New Use Rules on Certain Chemical Substances (20-2.5e);
Proposed Rule
Federal Register / Vol. 85, No. 197 / Friday, October 9, 2020 /
Proposed Rules
[[Page 64280]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2020-0131; FRL-10011-86]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances (20-
2.5e)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
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). The SNURs require persons
who intend to manufacture (defined by statute to include import) or
process any of these chemical substances for an activity that is
proposed as a significant new use by this rule to notify EPA at least
90 days before commencing that activity. The required notification
initiates EPA's evaluation of the use, under the conditions of use for
that chemical substance, within the applicable review period. Persons
may not commence manufacture or processing for the significant new use
until EPA has conducted a review of the notice, made an appropriate
determination on the notice, and has taken such actions as are required
by that determination.
DATES: Comments must be received on or before November 9, 2020.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2020-0131, through the Federal eRulemaking
Portal at https://www.regulations.gov. Follow the online instructions
for submitting comments. Do not submit electronically any information
you consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.
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, Chemical Control
Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; telephone number: (202) 564-4163; email address:
[email protected].
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you manufacture,
process, or use the chemical substances contained in this proposed
rule. The following list of North American Industrial Classification
System (NAICS) codes is not intended to be exhaustive, but rather
provides a guide to help readers determine whether this document
applies to them. Potentially affected entities may include:
Manufacturers or processors of one or more subject
chemical substances (NAICS codes 325 and 324110), e.g., chemical
manufacturing and petroleum refineries.
This action may also affect certain entities through pre-existing
import certification and export notification rules under TSCA. Chemical
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import
provisions promulgated at 19 CFR 12.118 through 12.127 and 19 CFR
127.28. Chemical importers must certify that the shipment of the
chemical substance complies with all applicable rules and Orders under
TSCA, which would include the SNUR requirements should these proposed
rules be finalized. The EPA policy in support of import certification
appears at 40 CFR part 707, subpart B. In addition, pursuant to 40 CFR
721.20, any persons who export or intend to export a chemical substance
that is the subject of this proposed rule on or after November 9, 2020
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/comments.html.
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 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-2020-0131, 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
[[Page 64281]]
sections 5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40
CFR part 720. Once EPA receives a SNUN and before the manufacture or
processing for the significant new use can commence, EPA must either
determine that the use is not likely to present an unreasonable risk of
injury under the conditions of use for the chemical substance or take
such regulatory action as is associated with an alternative
determination. If EPA determines that the use is not likely to present
an unreasonable risk, EPA is required under TSCA section 5(g) to make
public, and submit for publication in the Federal Register, a statement
of EPA's findings.
III. Significant New Use Determination
TSCA section 5(a)(2) states that EPA's determination that a use of
a chemical substance is a significant new use must be made after
consideration of all relevant factors, including:
The projected volume of manufacturing and processing of a
chemical substance.
The extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical substance.
The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance.
The reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of a
chemical substance.
In determining what would constitute a significant new use for the
chemical substances that are the subject of these SNURs, EPA considered
relevant information about the toxicity of the chemical substances,
potential human exposures and environmental releases that may be
associated with possible uses of these chemical substances, in the
context of the four TSCA section 5(a)(2) factors listed in this unit.
The proposed rules include PMN substances that are subject to
Orders issued under TSCA section 5(e)(1)(A), as required by the
determinations made under TSCA section 5(a)(3)(B). The TSCA Orders
require protective measures to limit exposures or otherwise mitigate
the potential unreasonable risk. The proposed SNURs identify
significant new uses as any manufacturing, processing, use,
distribution in commerce, or disposal that does not conform to the
restrictions imposed by the underlying TSCA Orders, consistent with
TSCA section 5(f)(4).
Where EPA determined that the PMN substance may present an
unreasonable risk of injury to human health via inhalation exposure,
the underlying TSCA Order usually requires that potentially exposed
employees wear specified respirators unless actual measurements of the
workplace air show that air-borne concentrations of the PMN substance
are below a New Chemical Exposure Limit (NCEL), and includes
requirements addressing performance criteria for sampling and
analytical methods, periodic monitoring, respiratory protection, and
recordkeeping. No comparable NCEL provisions currently exist in 40 CFR
part 721, subpart B, for SNURs. Therefore, for these cases, the
individual SNURs in 40 CFR part 721, subpart E, will state that persons
subject to the SNUR who wish to pursue NCELs as an alternative to the
40 CFR 721.63 respirator requirements may request to do so under 40 CFR
721.30. EPA expects that persons whose 40 CFR 721.30 requests to use
the NCELs approach for SNURs that are approved by EPA will be required
to comply with NCELs provisions that are comparable to those contained
in the corresponding TSCA Order for the same chemical substance.
These proposed rules include PMN substances that received ``not
likely to present an unreasonable risk'' determination in TSCA section
5(a)(3)(c). However, during the course of these reviews, EPA identified
concerns for certain health and/or environmental risks if the chemicals
were not used following the limitations identified by the submitters in
the notices. The proposed SNURs would identify as significant new uses
any manufacturing, processing, use, distribution in commerce, or
disposal that does not conform to the protection measures.
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).
Basis for the SNUR or TSCA Order.
Effective date of the TSCA Order (if applicable).
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-18-241, P-18-244, and P-18-245.
Chemical Names: 2-Propenoic acid, 2-methyl-, methyl ester, polymer
with ethenylbenzene, ethyl 2-propenoate, 2-oxiranylmethyl 2-methyl-2-
propenoate and 1,2-propanediol mono(2-methyl-2-propenoate), reaction
products with diethanolamine, polymers with substituted-alkyl acrylate,
formats (salts) (P-18-241) (generic); 2-Propenoic acid, 2-methyl,
methyl ester, polymer with ethenylbenzene, ethyl 2-propenoate, 2-
oxiranylmethyl 2-methyl-2-propenoate and 1,2-propanediol mono(2-methyl-
2-propenoate), reaction products with diethanolamine, polymers with
substituted-alkyl methacrylate, formats (salts) (P-18-244) (generic);
2-Propenoic acid, 2-methyl-, methyl ester, polymer with ethenylbenzene,
ethyl 2-propenoate, 2-oxrianylmethyl 2-methyl-2-propenoate, and 1,2-
propaneidol mono(2-methyl-2-propenoate), reaction products with
diethanolamine, polymers with alkylene glycol monoacrylate, formats
(salts) (P-18-245) (generic).
CAS Numbers: Not available.
Basis for the action: The PMNs state that the generic (non-
confidential) use of the substances will be as additives for automotive
coatings. EPA estimated the human health hazard of the chemical
substances based on their measured and estimated physical/chemical
properties and by comparison with structurally analogous chemical
substances. EPA determined environmental hazard for the new chemical
substances based on Structural Activity Relationships (SAR) analysis
for polycationic polymers. EPA has identified concerns for potential
neurotoxicity, blood toxicity, reproductive and developmental toxicity,
and moderate environmental hazard if the chemical substances are not
manufactured and not used following the limitations identified by the
submitters in the notices. This proposed SNUR designates the following
circumstances of use as ``significant new uses'' requiring further
review by EPA:
Use of the PMN substances other than as described in the
PMNs.
Potentially useful information: EPA has determined that information
about the human health and environmental effects of the PMN substances
may be potentially useful if a manufacturer or processor is considering
submitting a SNUN for a significant new use that would be designated by
this proposed SNUR. EPA has determined that the results of
neurotoxicity, reproductive/developmental toxicity, and aquatic
[[Page 64282]]
toxicity testing would help characterize the potential health and
environmental effects of the PMN substances.
CFR Citations: 40 CFR 721.11401 (P-18-241), 40 CFR 721.11402 (P-18-
244), and 40 CFR 721.11403 (P-18-245).
PMN Numbers: P-16-539, P-18-157, P-18-158, P-18-159, and P-19-33.
Chemical Names: Organic sulfonate compound (generic) (P-16-539),
thiophenium, 1-(2,7-disubstituted-1-naphthalenyl)tetrahydro-, salt with
polyfluoro-N-polyfluoroalkylsulfonyl-1-alkanesulfonamide (1:1)
(generic) (P-18-157), sulfonium, triphenyl-, salt with 2,3-
bis(substituted) 5-sulfocarbopolycyclic-2,3-carboxylate derivative
(1:1) (generic) (P-18-158), thiophenium, 1-(2,7-disubstituted-1-
naphthalenyl)tetrahydro-, salt with polyfluoro-N-
polyfluoroalkylsulfonyl-1-alkanesulfonamide (1:1) (P-18-159), and
sulfonium, triphenyl-, 5-(alkyl) fluoropentane derivative (generic) (P-
19-33).
CAS Numbers: Not available.
Effective Date of TSCA Order: January 31, 2020.
Basis for TSCA Order: The PMNs state that the generic (non-
confidential) use of the substances will be for photolithography (P-16-
539, P-18-158, and P-19-33) and as a photosensitizer for photoresist
(P-18-158 and P-18-159). 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 the New Chemical Program's PBT
category policy statement (64 FR 60194, November 4, 1999; 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 physical/chemical properties
and comparison with analogous chemical substances, EPA has also
identified concerns for photosensitization, eye corrosion, irritation,
acute toxicity, neurotoxicity, lung overload, aquatic toxicity, and
reproductive/developmental toxicity. The TSCA 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 TSCA Order requires:
1. No manufacture of any of the PMN substances beyond the time
limits specified in the TSCA Order without submittal to EPA of the
results of certain testing described in the Testing section of the TSCA
Order;
2. Use of personal protective equipment where there is a potential
for dermal exposure;
3. Establishment of a hazard communication program, including human
health precautionary statements on each label and in the Safety Data
Sheet (SDS);
4. No modification of the processing of the PMN substances in any
way that generates a dust, mist, or aerosol in a non-enclosed process;
5. Use of the PMN substances only as described in the TSCA Order;
6. No domestic manufacture of the PMN substances (i.e., import
only);
7. Import of the PMN substances only in solution, or in any form in
sealed containers weighing 5 kilograms or less; and
8. No exceedance of the confidential annual production volumes
listed in the TSCA 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 TSCA 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 TSCA Order without performing
the required Tier I and Tier II testing outlined in the Testing section
of the TSCA Order.
CFR Citations: 40 CFR 721.11514 (P-16-539), 40 CFR 721.11515 (P-18-
157), 40 CFR 721.11516 (P-18-158), 40 CFR 721.11517 (P-18-159), and 40
CFR 721.11518 (P-19-33).
PMN Numbers: P-17-178, P-18-13, P-18-14, P-18-37, P-19-78, P-19-79,
P-19-111, P-19-112, P-19-114 and P-19-133.
Chemical Names: Sulfonium, triphenyl-, salt with substituted-alkyl
4-substituted-benzoate (generic) (P-17-178), substituted-
triphenylsulfonium, inner salt (generic) (P-18-13), sulfonium,
triphenyl-, salt with disubstituted-heterocyclic compound (1:1)
(generic) (P-18-14), sulfonium, triphenyl-, salt with 2,4,5-
trisubstituted-benzenesulfonate (1:1) (generic) (P-18-37), substituted
heterocyclic onium compound, salt with 2,2,2-trifluoro-1-(sulfomethyl)-
1-(trifluoromethyl)ethyl 3-[(2-methyl-1-oxo-2-propen-1-
yl)oxy]tricyclo[3.3.1.13,7]decane-1-carboxylate (1:1), polymer with
acenaphthylene, 1-ethenyl-4-[(1-ethylcyclopentyl)oxy]benzene and 4-
ethenylphenol, di-Me 2,2'-(1,2-diazenediyl)bis[2-methylpropanoate]-
initiated (generic) (P-19-78), substituted heterocyclic onium compound,
salt with 2,2,2-trifluoro-1-(sulfomethyl)-1-(trifluoromethyl)ethyl 3-
[(2-methyl-1-oxo-2-propen-1-yl)oxy]tricyclo[3.3.1.13,7]decane-1-
carboxylate (1:1), polymer with acenaphthylene 1-ethenyl-4-[[1-(1-
methylethyl)cyclopentyl]oxy]benzene and 4-ethenylphenol, di-Me 2,2'-
(1,2-diazenediyl)bis[2-methylpropanoate]-initiated (generic) (P-19-79),
dibenzothiophenium, aryl substituted trifluoro-hydroxy-
(triheterosubstitutedalkyl)alkanoate (1:1) (generic) (P-19-111),
substituted heterocyclic onium compound, salt with 1-
(difluorosulfomethyl)-2,2,2-trifluoroethyl 3-[(2-methyl-1-oxo-2-propen-
1-yl)oxy]tricyclo[3.3.1.13,7]decane-1-carboxylate (1:1), polymer with
3-ethenylphenol, 1-(1-methylethyl)cyclopentyl 2-methyl-2-propenoate and
1-(7-oxabicyclo[2.2.1]hept-2-yl)cyclopentyl 2-methyl-2-propenoate, di-
Me 2,2'-(1,2-diazenediyl)bis[2-methylpropenoate]-initiated (generic)
(P-19-112), sulfonium, triphenyl-, trifluoro-hydroxy-
(triheterosubstitutedalkyl)alkanoate (1:1) (generic) (P-19-114), and
heterotrisubstituted-bile acid, 1-(difluorosulfomethyl)-2,2,2-
trifluoroethyl ester, ion(1-), (5)-, triphenylsulfonium (1:1) (generic)
(P-19-133).
CAS Numbers: Not available.
Effective Date of TSCA Order: January 31, 2020.
Basis for TSCA Order: The PMNs state that the generic (non-
confidential) uses of the substances will be for microlithography for
electronic device manufacturing (P-17-178, P-18-13, P-18-14, and P-18-
37), polymers for photo resist (P-19-78 and P-17-79), and
microlithography for electronic device manufacturing (P-19-78, P-19-79,
P-19-111, P-19-112, P-19-114, and P-19-133). Based on the physical/
chemical properties of the PMN substances and test data on structurally
similar substances, the PMN substances are potentially PBT chemicals
(as described in the New Chemical Program's PBT category policy
statement (64 FR 60194, November 4, 1999; FRL-6097-7)). EPA estimates
that the PMN substances will persist in the environment more than 2
months and estimates a bioaccumulation factor of
[[Page 64283]]
greater than or equal to 1,000. Based on physical/chemical properties
and comparison with analogous chemical substances, EPA has also
identified concerns for photosensitization, eye corrosion, irritation,
acute toxicity, neurotoxicity, lung overload, aquatic toxicity, and
reproductive/developmental toxicity. 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
TSCA Order requires:
1. No manufacture of any of the PMN substances beyond the time
limits specified in the TSCA Order without submittal to EPA of the
results of certain testing described in the Testing section of the TSCA
Order;
2. Use of personal protective equipment where there is a potential
for dermal exposure;
3. Establishment of a hazard communication program, including human
health precautionary statements on each label and in the SDS;
4. No modification of the processing of the PMN substances in any
way that generates a dust, mist, or aerosol in a non-enclosed process;
5. Use of the PMN substances only as described in the TSCA Order;
6. No domestic manufacture of the PMN substances (i.e., import
only);
7. Import of the PMN substances only in solution, or in any form in
sealed containers weighing 5 kilograms or less; and
8. No exceedance of the confidential annual importation volumes
listed in the TSCA 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 TSCA 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 TSCA Order without performing
the required Tier I and Tier II testing outlined in the Testing section
of the TSCA Order.
CFR Citations: 40 CFR 721.11519 (P-17-178), 40 CFR 721.11520 (P-18-
13), 40 CFR 721.11521 (P-18-14), 40 CFR 721.11522 (P-18-37), 40 CFR
721.11523 (P-19-78), 40 CFR 721.11524 (P-19-79), 40 CFR 721.11525 (P-
19-111), 40 CFR 721.11526 (P-19-112), 40 CFR 721.11527 (P-19-114), and
40 CFR 721.11528 (P-19-133).
PMN Number: P-18-16.
Chemical Name: Aromatic sulfonium tricyclo fluoroalkyl sulfonic
acid salt (generic).
CAS Number: None available.
Effective Date of TSCA Order: February 11, 2020.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a photoacid generator (PAG). Based on the
physical/chemical properties of the PMN substance, the PMN substance is
a potentially PBT chemical (as described in the New Chemical Program's
PBT category policy statement (64 FR 60194, November 4, 1999; 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 physical/chemical
properties and comparison with analogous chemical substances, EPA has
also identified concerns for photosensitization, eye corrosion,
irritation, acute toxicity, liver toxicity, neurotoxicity,
reproductive/developmental toxicity, and aquatic toxicity. 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 TSCA Order requires:
1. No manufacture of the PMN substance beyond the time limits
specified in the TSCA Order without submittal to EPA of the results of
certain testing described in the Testing section of the TSCA Order;
2. Use of personal protective equipment where there is a potential
for dermal exposure;
3. Establishment of a hazard communication program, including human
health precautionary statements on each label and in the SDS;
4. No modification of the processing of the PMN substance in any
way that generates a dust, mist, or aerosol in a non-enclosed process;
5. Use of the PMN substance only as described in the TSCA Order;
6. No domestic manufacture of the PMN substance (i.e., import
only);
7. Import of the PMN substance only in solution, or in any form in
sealed containers weighing 5 kilograms or less; and
8. No exceedance of the confidential annual importation volume
listed in the TSCA 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 TSCA 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 TSCA Order without performing
the required Tier I and Tier II testing outlined in the Testing section
of the TSCA Order.
CFR Citation: 40 CFR 721.11529.
PMN Numbers: P-18-297, P-18-311, P-18-314, and P-18-315.
Chemical Names: Substituted, (alkylaromatic)diaromatic salt with
trihalo-[(trihaloalkyl)substituted]substituted alkaneamide (generic)
(P-18-297), triarylsulfonium substituted oxatricycloalkyloxycarbonyl
dihalo alkane sulfonate (generic) (P-18-311), substituted
triarylsulfonium carbopolycyclic heteromonocyclic dihalo sulfoacetate
(generic) (P-18-314), and substituted triarylsulfonium substituted
carbopolycyclic carboxylate (generic) (P-18-315).
CAS Numbers: Not available.
Effective Date of TSCA Order: February 4, 2020.
Basis for TSCA Order: The PMNs state that the generic (non-
confidential) use of the substances will be as components of material
for fabrication. Based on the physical/chemical properties of the PMN
substances and test data on structurally similar substances, the PMN
substances are potentially PBT chemicals (as described in the New
Chemical Program's PBT category policy statement (64 FR 60194, November
4, 1999; FRL-6097-7)). EPA estimates that the PMN substances will
persist in the environment more than 2 months and estimates a
bioaccumulation factor of greater than or equal to 1,000. Based on
physical/chemical properties and comparison with analogous chemical
substances, EPA has also identified concerns for photosensitization,
eye corrosion, irritation, acute toxicity, neurotoxicity, lung
overload, aquatic toxicity, and reproductive/developmental toxicity.
The Order was issued under TSCA sections
[[Page 64284]]
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 TSCA Order
requires:
1. No manufacture of any of the PMN substances beyond the time
limits specified in the TSCA Order without submittal to EPA of the
results of certain testing described in the Testing section of the TSCA
Order;
2. Use of personal protective equipment where there is a potential
for dermal exposure;
3. Establishment of a hazard communication program, including human
health precautionary statements on each label and in the SDS;
4. No modification of the processing of the PMN substances in any
way that generates a dust, mist, or aerosol in a non-enclosed process;
5. Use of the PMN substances only as described in the TSCA Order;
6. No domestic manufacture of the PMN substances (i.e., import
only);
7. Import of the PMN substances only in solution, or in any form in
sealed containers weighing 5 kilograms or less; and
8. No exceedance of the confidential annual importation volumes
listed in the TSCA 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 TSCA 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 TSCA Order without performing
the required Tier I and Tier II testing outlined in the Testing section
of the TSCA Order.
CFR Citations: 40 CFR 721.11530 (P-18-297), 40 CFR 721.11531 (P-18-
311), 40 CFR 721.11532 (P-18-314), and 40 CFR 721.11533 (P-18-315).
PMN Numbers: P-18-304, P-18-316, P-18-338, P-19-76, P-19-115, and
P-19-142.
Chemical Names: Sulfonium, bis(dihalocarbomonocycle)
carbomonocycle, salt with substituted heteropolycycle dihalo
sulfoalkanoate (1:1) (generic) (P-18-304), heteropolycycle,
alkylaromatic-, salt with dihalo-substituted alkyl carbopolycycle
carboxylate (generic) (P-18-316), sulfonium, triaryl-, salt with
polyhalo-4-sulfoalkyl polycarbocyclic alkane-1-carboxylate (1:1) (P-18-
338), sulfonium, bis(dihalocarbomonocycle) carbomonocycle, salt with
dihalo substituted alkyl carbopolycyclic carboxylate (1:1) (generic)
(P-19-76), sulfonium, bis(dihalocarbomonocycle) carbomonocycle,
substituted carbomonocyclic ester (generic) (P-19-115), and
heteropolycycle, aromatic-, salt with dihalo-substituted alkyl
carbopolycycle carboxylate (1:1) (generic) (P-19-142).
CAS Numbers: Not available.
Effective Date of TSCA Order: January 30, 2020.
Basis for TSCA Order: The PMNs state that the generic (non-
confidential) use of the substances will be as ingredients used in the
manufacture of photoresist. Based on the physical/chemical properties
of the PMN substances and test data on structurally similar substances,
the PMN substances are potentially PBT chemicals (as described in the
New Chemical Program's PBT category policy statement (64 FR 60194,
November 4, 1999; FRL-6097-7)). EPA estimates that the PMN substances
will persist in the environment more than 2 months and estimates a
bioaccumulation factor of greater than or equal to 1,000. Based on
physical/chemical properties and comparison with analogous chemical
substances, EPA has also identified concerns for photosensitization,
eye corrosion, irritation, acute toxicity, neurotoxicity, lung
overload, aquatic toxicity, and reproductive/developmental toxicity.
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 TSCA Order requires:
1. No manufacture of any of the PMN substances beyond the time
limits specified in the TSCA Order without submittal to EPA of the
results of certain testing described in the Testing section of the TSCA
Order;
2. Use of personal protective equipment where there is a potential
for dermal exposure;
3. Establishment of a hazard communication program, including human
health precautionary statements on each label and in the SDS;
4. No modification of the processing of the PMN substances in any
way that generates a dust, mist, or aerosol in a non-enclosed process;
5. Use of the PMN substances only as described in the PMNs;
6. No domestic manufacture of the PMN substances (i.e., import
only);
7. Import of the PMN substances only in solution, or in any form in
sealed containers weighing 5 kilograms or less; and
8. No exceedance of the confidential annual importation volumes
listed in the TSCA 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 TSCA 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 TSCA Order without performing
the required Tier I and Tier II testing outlined in the Testing section
of the TSCA Order.
CFR Citations: 40 CFR 721.11534 (P-18-304), 40 CFR 721.11535 (P-18-
316), 40 CFR 721.11536 (P-18-338), 40 CFR 721.11537 (P-19-76), 40 CFR
721.11538 (P-19-115), and 40 CFR 721.11539 (P-19-142).
PMN Number: P-19-166.
Chemical Name: Triarylsulfonium alkylestersulfonate (generic).
CAS Number: None available.
Effective Date of TSCA Order: February 12, 2020.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a photoacid generator (PAG). Based on the
physical/chemical properties of the PMN substance, the PMN substance is
a potentially persistent, bioaccumulative, and toxic (PBT) chemical (as
described in the New Chemical Program's PBT category at 64 FR 60194;
November 1999). 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 physical/chemical
properties and comparison with analogous chemical substances, EPA has
also identified concerns for photosensitization, eye corrosion,
irritation, acute toxicity, liver toxicity, neurotoxicity,
reproductive/developmental toxicity, and aquatic toxicity. The Order
was issued under
[[Page 64285]]
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 TSCA Order requires:
1. No manufacture of the PMN substance beyond the time limits
specified in the TSCA Order without submittal to EPA of the results of
certain testing described in the Testing section of the TSCA Order;
2. Use of personal protective equipment where there is a potential
for dermal exposure;
3. Establishment of a hazard communication program, including human
health precautionary statements on each label and in the SDS;
4. No modification of the processing of the PMN substance in any
way that generates a dust, mist, or aerosol in a non-enclosed process;
5. Use of the PMN substance only as described in the TSCA Order;
6. No domestic manufacture of the PMN substance (import only);
7. Import of the PMN substance only in solution, or in any form in
sealed containers weighing 5 kilograms or less; and
8. No exceedance of the confidential annual importation volume
listed in the TSCA 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 TSCA 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 TSCA Order without performing
the required Tier I and Tier II testing outlined in the Testing section
of the TSCA Order.
CFR Citation: 40 CFR 721.11540.
PMN Numbers: P-19-168, P-19-169, P-19-171, P-19-172, P-19-173, P-
19-175, P-19-176, P-19-177, P-19-178, P-19-179, P-19-180, P-19-181, P-
19-182, P-19-184, and P-19-187.
Chemical Names: Halogenated alkylbenzoic acid (generic) (P-19-168,
P-19-169, P-19-175, P-19-176, P-19-177, P-19-178, and P-19-179),
halogenated benzoic acid (P-19-171, P-19-172, and P-19-173),
halogenated sodium benzoate (P-19-180, P-19-181, and P-19-182), and
halogenated sodium alkylbenzoate (P-19-184 and P-19-187).
CAS Numbers: Not available.
Effective Date of TSCA Order: January 31, 2020.
Basis for TSCA Order: The PMNs states that the generic (non-
confidential) use will be to monitor oil and gas well performance (P-
19-180, P-19-181, P-19-182, P-19-184, and P-19-187) and as well
performance tracers (P-19-168, P-19-169, P-19-171, P-19-172, P-19-173,
P-19-175, P-19-176, P-19-177, P-19-178, and P-19-179). Based on the
estimated physical/chemical properties of the PMN substances and
comparison with analogous chemical substances, EPA has identified
concerns for developmental toxicity and neurotoxicity for all of the
PMN substances and additionally irritation to skin, eyes, and
respiratory tract for P-19-168, P-19-169, P-19-171, P-19-172, P-19-173,
P-19-175, P-19-176, P-19-177, P-19-178, and P-19-179. 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 TSCA Order requires:
1. No manufacture (including import), processing, or use of any of
the PMN substances other than for the confidential use described in
each PMN;
2. Submission to EPA of certain toxicity testing before
manufacturing (including import) beyond the confidential cumulative
production volumes listed in the Testing Section of the TSCA Order;
3. Use of personal protective equipment where there is a potential
for dermal exposure to PMN substances P-19-168, P-19-169, P-19-171, P-
19-172, P-19-173, P-19-175, P-19-176, P-19-177, P-19-178, or P-19-179;
4. Use of engineering controls/processes as specified in the TSCA
Order;
5. Use of a NIOSH-certified respirator with an APF of at least 10
where there is a potential for inhalation exposure to PMN substances P-
19-168, P-19-169, P-19-171, P-19-172, P-19-173, P-19-175, P-19-176, P-
19-177, P-19-178, or P-19-179 or compliance with a NCEL of 0.0195 mg/
m\3\ as an 8-hour time-weighted average to prevent inhalation exposure;
6. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS;
7. No manufacture or use of PMN substances P-19-180, P-19-181, P-
19-182, P-19-184, or P-19-187 other than in liquid formulations; and
8. No manufacture of the PMN substances P-19-168, P-19-169, P-19-
171, P-19-172, P-19-173, P-19-175, P-19-176, P-19-177, P-19-178, or P-
19-179 beyond the confidential annual production volume limit specified
in the TSCA 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 human health effects of the PMN substances may be
potentially useful in support of a request by the PMN submitter to
modify the TSCA Order, or if a manufacturer or processor is considering
submitting a SNUN for a significant new use that will be designated by
this SNUR. EPA has determined that the results of skin irritation, eye
damage, neurotoxicity, reproductive/developmental toxicity, pulmonary
effects, and specific target organ toxicity testing may be potentially
useful to characterize the human health effects of the PMN substances.
Although the TSCA Order does not require these tests, the TSCA Order's
restrictions remain in effect until the TSCA Order is modified or
revoked by EPA based on submission of this or other relevant
information.
CFR Citations: 40 CFR 721.11541 (P-19-168), 40 CFR 721.11542 (P-19-
169), 40 CFR 721.11543 (P-19-171), 40 CFR 721.11544 (P-19-172), 40 CFR
721.11545 (P-19-173), 40 CFR 721.11546 (P-19-175), 40 CFR 721.11547 (P-
19-176), 40 CFR 721.11548 (P-19-177), 40 CFR 721.11549 (P-19-178), 40
CFR 721.11550 (P-19-179), 40 CFR 721.11551 (P-19-180), 40 CFR 721.11552
(P-19-181), 40 CFR 721.11553 (P-19-182), 40 CFR 721.11554 (P-19-184),
and 40 CFR 721.11555 (P-19-187).
V. Rationale and Objectives of the Proposed Rule
A. Rationale
During review of the PMNs submitted for some of 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
[[Page 64286]]
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.
During review of the other chemical substances that are the subject
of these proposed SNURs and as further discussed in Unit IV., EPA
identified certain other circumstances of use different from the
intended conditions of use identified in the PMNs and determined that
those changes could result in changes in the type or form of exposure
to the chemical substances and/or increased exposures to the chemical
substances and/or changes in the reasonably anticipated manner and
methods of manufacturing, processing, distribution in commerce, and
disposal of the chemical substances.
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 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 42
of the 45 chemical substances that are the subject of this proposed
SNUR, and the PMN submitters are prohibited by the TSCA Orders from
undertaking activities which would be designated as significant new
uses. The identities of all 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 October 9, 2020 as the cutoff date for
determining whether the new use is ongoing. The objective of EPA's
approach is to ensure that a person cannot defeat a SNUR by initiating
a significant new use before the effective date of the final rule.
In the unlikely event that a person began commercial manufacture or
processing of the chemical substances for a significant new use
identified as of that date would have to cease any such activity upon
the effective date of the final rule. To resume their activities, these
persons would have to first comply with all applicable SNUR
notification requirements and wait until EPA has conducted a review of
the notice, made an appropriate determination on the notice, and has
taken such actions as are required with that determination.
Issuance of a SNUR for a chemical substance does not signify that
the chemical substance is listed on the TSCA Chemical Substance
Inventory (TSCA Inventory). Guidance on how to determine if a chemical
substance is on the TSCA Inventory is available on the internet at
https://www.epa.gov/tsca-inventory.
VII. Development and Submission of Information
EPA recognizes that TSCA section 5 does not require developing any
particular new information (e.g., generating test data) before
submission of a SNUN. There is an exception: If a person is required to
submit information for a chemical substance pursuant to a rule, TSCA
Order or consent agreement under TSCA section 4, then TSCA section
5(b)(1)(A) requires such information to be submitted to EPA at the time
of submission of the SNUN.
In the absence of a rule, 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 (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 all SNURs listed here. Descriptions of this
information is provided for informational purposes. The potentially
useful information identified in Unit IV. of the proposed rule will be
useful to EPA's evaluation in the event that someone submits a SNUN for
the significant new use. Companies who are considering submitting a
SNUN are encouraged, but not required, to develop the information on
the substance, which may assist with EPA's analysis of the SNUN. 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 on 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 potentially useful information. EPA
encourages dialogue with Agency representatives to help determine how
best the submitter can meet both the data needs and the objective of
TSCA section 4(h). To access the OCSPP test guidelines referenced in
this document electronically, please go to https://www.epa.gov/ocspp and
select ``Test Methods and Guidelines.'' The Organisation for Economic
Co-operation and Development (OECD) test guidelines are available from
the OECD Bookshop at https://www.oecdbookshop.org or SourceOECD at
https://www.sourceoecd.org.
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:
[[Page 64287]]
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 under docket ID number EPA-HQ-OPPT-
2020-0131.
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 proposed rule would 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 related to this action have
already been approved by OMB under the PRA under 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 proposed rule is not subject to Executive Order 13045 (62 FR
19885, April 23, 1997), because this is not an economically significant
regulatory
[[Page 64288]]
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 proposed rule 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.
Dated: September 14, 2020.
Tala Henry,
Deputy Director, Office of Pollution Prevention and Toxics.
Therefore, for the reasons stated in the preamble, it is proposed
that 40 CFR chapter I be amended as follows:
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, 2613, and 2625(c).
0
2. Add Sec. Sec. 721.11401 through 721.11403 and Sec. Sec. 721.11514
through 721.11555 to subpart E to read as follows:
Subpart E--Significant New Uses for Specific Chemical Substances
* * * * *
Sec.
* * * * *
721.11401 2-Propenoic acid, 2-methyl-, methyl ester, polymer with
ethenylbenzene, ethyl 2-propenoate, 2-oxiranylmethyl 2-methyl-2-
propenoate and 1,2-propanediol mono(2-methyl-2-propenoate), reaction
products with diethanolamine, polymers with substituted-alkyl
acrylate, formats (salts) (generic).
721.11402 2-Propenoic acid, 2-methyl, methyl ester, polymer with
ethenylbenzene, ethyl 2-propenoate, 2-oxiranylmethyl 2-methyl-2-
propenoate and 1,2-propanediol mono(2-methyl-2-propenoate), reaction
products with diethanolamine, polymers with substituted-alkyl
methacrylate, formats (salts) (generic).
721.11403 2-Propenoic acid, 2-methyl-, methyl ester, polymer with
ethenylbenzene, ethyl 2-propenoate, 2-oxrianylmethyl 2-methyl-2-
propenoate, and 1,2-propaneidol mono(2-methyl-2-propenoate),
reaction products with diethanolamine, polymers with alkylene glycol
monoacrylate, formats (salts) (generic).
* * * * *
721.11514 Organic sulfonate compound (generic).
721.11515 Thiophenium, 1-(2,7-disubstituted-1-
naphthalenyl)tetrahydro-, salt with polyfluoro-N-
polyfluoroalkylsulfonyl-1-alkanesulfonamide (1:1) (generic).
721.11516 Sulfonium, triphenyl-, salt with 2,3-bis(substituted) 5-
sulfocarbopolycyclic-2,3-carboxylate derivative (1:1) (generic).
721.11517 Thiophenium, 1-(2,7-disubstituted-1-
naphthalenyl)tetrahydro-, salt with polyfluoro-N-
polyfluoroalkylsulfonyl-1-alkanesulfonamide (1:1) (generic).
721.11518 Sulfonium, triphenyl-, 5-(alkyl) fluoropentane derivative
(generic).
721.11519 Sulfonium, triphenyl-, salt with substituted-alkyl 4-
substituted-benzoate (generic).
721.11520 Substituted-triphenylsulfonium, inner salt (generic).
721.11521 Sulfonium, triphenyl-, salt with disubstituted-
heterocyclic compound (1:1) (generic).
721.11522 Sulfonium, triphenyl-, salt with 2,4,5-trisubstituted-
benzenesulfonate (1:1) (generic).
721.11523 Substituted heterocyclic onium compound, salt with 2,2,2-
trifluoro-1-(sulfomethyl)-1-(trifluoromethyl)ethyl 3-[(2-methyl-1-
oxo-2-propen-1-yl)oxy]tricyclo[3.3.1.13,7]decane-1-carboxylate
(1:1), polymer with acenaphthylene, 1-ethenyl-4-[(1-
ethylcyclopentyl)oxy]benzene and 4-ethenylphenol, di-Me 2,2'-(1,2-
diazenediyl)bis[2-methylpropanoate]-initiated (generic).
721.11524 Substituted heterocyclic onium compound, salt with 2,2,2-
trifluoro-1-(sulfomethyl)-1-(trifluoromethyl)ethyl 3-[(2-methyl-1-
oxo-2-propen-1-yl)oxy]tricyclo[3.3.1.13,7]decane-1-carboxylate
(1:1), polymer with acenaphthylene 1-ethenyl-4-[[1-(1-
methylethyl)cyclopentyl]oxy]benzene and 4-ethenylphenol, di-Me 2,2'-
(1,2-diazenediyl)bis[2-methylpropanoate]-initiated (generic).
721.11525 Dibenzothiophenium, aryl substituted trifluoro-hydroxy-
(triheterosubstitutedalkyl)alkanoate (1:1) (generic).
721.11526 Substituted heterocyclic onium compound, salt with 1-
(difluorosulfomethyl)-2,2,2-trifluoroethyl 3-[(2-methyl-1-oxo-2-
propen-1-yl)oxy]tricyclo[3.3.1.13,7]decane-1-carboxylate (1:1),
polymer with 3-ethenylphenol, 1-(1-methylethyl)cyclopentyl 2-methyl-
2-propenoate and 1-(7-oxabicyclo[2.2.1]hept-2-yl)cyclopentyl 2-
methyl-2-propenoate, di-Me 2,2'-(1,2-diazenediyl)bis[2-
methylpropenoate]-initiated (generic).
721.11527 Sulfonium, triphenyl-, trifluoro-hydroxy-
(triheterosubstitutedalkyl)alkanoate (1:1) (generic).
721.11528 Heterotrisubstituted-bile acid, 1-(difluorosulfomethyl)-
2,2,2-trifluoroethyl ester, ion(1-), (5)-, triphenylsulfonium (1:1)
(generic).
721.11529 Aromatic sulfonium tricyclo fluoroalkyl sulfonic acid salt
(generic)
721.11530 Substituted, (alkylaromatic)diaromatic salt with trihalo-
[(trihaloalkyl)substituted]substituted alkaneamide (generic).
721.11531 Triarylsulfonium substituted oxatricycloalkyloxycarbonyl
dihalo alkane sulfonate (generic).
721.11532 Substituted triarylsulfonium carbopolycyclic
heteromonocyclic dihalo sulfoacetate (generic).
721.11533 Substituted triarylsulfonium substituted carbopolycyclic
carboxylate (generic).
721.11534 Sulfonium, bis(dihalocarbomonocycle) carbomonocycle, salt
with substituted heteropolycycle dihalo sulfoalkanoate (1:1)
(generic).
721.11535 Heteropolycycle, alkylaromatic-, salt with dihalo-
substituted alkyl carbopolycycle carboxylate (generic).
721.11536 Sulfonium, triaryl-, salt with polyhalo-4-sulfoalkyl
polycarbocyclic alkane-1-carboxylate (1:1) (generic).
721.11537 Sulfonium, bis(dihalocarbomonocycle) carbomonocycle, salt
with dihalo substituted alkyl carbopolycyclic carboxylate (1:1)
(generic).
721.11538 Sulfonium, bis(dihalocarbomonocycle) carbomonocycle,
substituted carbomonocyclic ester (generic).
721.11539 Heteropolycycle, aromatic-, salt with dihalo-substituted
alkyl carbopolycycle carboxylate (1:1) (generic).
721.11540 Triarylsulfonium alkylestersulfonate (generic).
721.11541 Halogenated alkylbenzoic acid (generic).
721.11542 Halogenated alkylbenzoic acid (generic).
721.11543 Halogenated benzoic acid (generic).
721.11544 Halogenated benzoic acid (generic).
721.11545 Halogenated benzoic acid (generic).
721.11546 Halogenated alkylbenzoic acid (generic).
721.11547 Halogenated alkylbenzoic acid (generic).
721.11548 Halogenated alkylbenzoic acid (generic).
[[Page 64289]]
721.11549 Halogenated alkylbenzoic acid (generic).
721.11550 Halogenated alkylbenzoic acid (generic).
721.11551 Halogenated sodium benzoate (generic).
721.11552 Halogenated sodium benzoate (generic).
721.11553 Halogenated sodium benzoate (generic).
721.11554 Halogenated sodium alkylbenzoate (generic).
721.11555 Halogenated sodium alkylbenzoate (generic).
* * * * *
Sec. 721.11401 2-Propenoic acid, 2-methyl-, methyl ester, polymer
with ethenylbenzene, ethyl 2-propenoate, 2-oxiranylmethyl 2-methyl-2-
propenoate and 1,2-propanediol mono(2-methyl-2-propenoate), reaction
products with diethanolamine, polymers with substituted-alkyl acrylate,
formats (salts) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as 2-
propenoic acid, 2-methyl-, methyl ester, polymer with ethenylbenzene,
ethyl 2-propenoate, 2-oxiranylmethyl 2-methyl-2-propenoate and 1,2-
propanediol mono(2-methyl-2-propenoate), reaction products with
diethanolamine, polymers with substituted-alkyl acrylate, formats
(salts) (PMN P-18-241) 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(j).
(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 (i) are applicable to manufacturers and
processors of these substances.
(2) Limitations 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)(i) of
this section.
Sec. 721.11402 2-Propenoic acid, 2-methyl, methyl ester, polymer
with ethenylbenzene, ethyl 2-propenoate, 2-oxiranylmethyl 2-methyl-2-
propenoate and 1,2-propanediol mono(2-methyl-2-propenoate), reaction
products with diethanolamine, polymers with substituted-alkyl
methacrylate, formats (salts) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as 2-
propenoic acid, 2-methyl, methyl ester, polymer with ethenylbenzene,
ethyl 2-propenoate, 2-oxiranylmethyl 2-methyl-2-propenoate and 1,2-
propanediol mono(2-methyl-2-propenoate), reaction products with
diethanolamine, polymers with substituted-alkyl methacrylate, formats
(salts) (PMN P-18-244) 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(j).
(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 (i) are applicable to manufacturers and
processors of these substances.
(2) Limitations 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)(i) of
this section.
Sec. 721.11403 2-Propenoic acid, 2-methyl-, methyl ester, polymer
with ethenylbenzene, ethyl 2-propenoate, 2-oxrianylmethyl 2-methyl-2-
propenoate, and 1,2-propaneidol mono(2-methyl-2-propenoate), reaction
products with diethanolamine, polymers with alkylene glycol
monoacrylate, formats (salts) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as 2-
propenoic acid, 2-methyl-, methyl ester, polymer with ethenylbenzene,
ethyl 2-propenoate, 2-oxrianylmethyl 2-methyl-2-propenoate, and 1,2-
propaneidol mono(2-methyl-2-propenoate), reaction products with
diethanolamine, polymers with alkylene glycol monoacrylate, formats
(salts) (PMN P-18-245) 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(j).
(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 (i) are applicable to manufacturers and
processors of these substances.
(2) Limitations 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)(i) of
this section.
* * * * *
Sec. 721.11514 Organic sulfonate compound (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as organic
sulfonate compound (PMN P-16-539) 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 PMN substance after they have been completely reacted
or adhered (during the photolithographic process) onto a semiconductor
water 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), (2)(i) and (iii), and (3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (e), (g)(1)(i), (2)(i) through (iii), and (v),
(3)(i) and (ii), and (5). For purposes of Sec. 721.72(e), the
concentration is set at 1.0%. For purposes of Sec. 721.72(g)(1)(i),
required human health hazard statements include acute toxicity, skin
sensitization, serious eye damage, specific target organ toxicity,
neurotoxicity, genetic toxicity, and reproductive toxicity.
(iii) Industrial, commercial, and consumer use. Requirements as
specified in Sec. 721.80(f), (k), and (t). It is a significant new use
to import the PMN substance other than in solution, unless in sealed
containers weighing 5 kilograms or less. It is a significant new use to
process the PMN substance in any way that generates a dust, mist, or
aerosol in a non-enclosed process. It is
[[Page 64290]]
a significant new use to manufacture the PMN substance longer than 18
months.
(b) Specific requirements. The provision 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) Limitations or revocation of certain modification 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. 721.11515 Thiophenium, 1-(2,7-disubstituted-1-
naphthalenyl)tetrahydro-, salt with polyfluoro-N-
polyfluoroalkylsulfonyl-1-alkanesulfonamide (1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
thiophenium, 1-(2,7-disubstituted-1-naphthalenyl)tetrahydro-, salt with
polyfluoro-N-polyfluoroalkylsulfonyl-1-alkanesulfonamide (1:1) (PMN P-
18-157) 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 PMN
substance after they have been completely reacted or adhered (during
the photolithographic process) onto a semiconductor water 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), (2)(i) and (iii), and (3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (e), (g)(1)(i), (2)(i) through (iii), and (v),
(3)(i) and (ii), and (5). For purposes of Sec. 721.72(e), the
concentration is set at 1.0%. For purposes of Sec. 721.72(g)(1)(i),
required human health hazard statements include acute toxicity, skin
sensitization, serious eye damage, specific target organ toxicity,
neurotoxicity, genetic toxicity, and reproductive toxicity.
(iii) Industrial, commercial, and consumer use. Requirements as
specified in Sec. 721.80(f), (k), and (t). It is a significant new use
to import the PMN substance other than in solution, unless in sealed
containers weighing 5 kilograms or less. It is a significant new use to
process the PMN substance in any way that generates a dust, mist, or
aerosol in a non-enclosed process. It is a significant new use to
manufacture the PMN substance longer than 18 months.
(b) Specific requirements. The provision 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) Limitations or revocation of certain modification 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. 721.11516 Sulfonium, triphenyl-, salt with 2,3-bis(substituted)
5-sulfocarbopolycyclic-2,3-carboxylate derivative (1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
sulfonium, triphenyl-, salt with 2,3-bis(substituted) 5-
sulfocarbopolycyclic-2,3-carboxylate derivative (1:1) (PMN P-18-158),
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 PMN substance after they have
been completely reacted or adhered (during the photolithographic
process) onto a semiconductor water 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), (2)(i) and (iii), and (3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (e), (g)(1)(i), (2)(i) through (iii), and (v),
(3)(i) and (ii), and (5). For purposes of Sec. 721.72(e), the
concentration is set at 1.0%. For purposes of Sec. 721.72(g)(1)(i),
required human health hazard statements include acute toxicity, skin
sensitization, serious eye damage, specific target organ toxicity,
neurotoxicity, genetic toxicity, and reproductive toxicity.
(iii) Industrial, commercial, and consumer use. Requirements as
specified in Sec. 721.80(f), (k), and (t). It is a significant new use
to import the PMN substance other than in solution, unless in sealed
containers weighing 5 kilograms or less. It is a significant new use to
process the PMN substance in any way that generates a dust, mist, or
aerosol in a non-enclosed process. It is a significant new use to
manufacture the PMN substance longer than 18 months.
(b) Specific requirements. The provision 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) Limitations or revocation of certain modification 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. 721.11517 Thiophenium, 1-(2,7-disubstituted-1-
naphthalenyl)tetrahydro-, salt with polyfluoro-N-
polyfluoroalkylsulfonyl-1-alkanesulfonamide (1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
thiophenium, 1-(2,7-disubstituted-1-naphthalenyl)tetrahydro-, salt with
polyfluoro-N-polyfluoroalkylsulfonyl-1-alkanesulfonamide (1:1) (PMN P-
18-159) 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 PMN
substance after they have been completely reacted or adhered (during
the photolithographic process) onto a semiconductor water surface or
similar manufactured article used in the production of semiconductor
technologies.
(2) The significant new uses are:
[[Page 64291]]
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (2)(i) and (iii), and (3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (e), (g)(1)(i), (2)(i) through (iii), and (v),
(3)(i) and (ii), and (5). For purposes of Sec. 721.72(e), the
concentration is set at 1.0%. For purposes of Sec. 721.72(g)(1)(i),
required human health hazard statements include acute toxicity, skin
sensitization, serious eye damage, specific target organ toxicity,
neurotoxicity, genetic toxicity, and reproductive toxicity.
(iii) Industrial, commercial, and consumer use. Requirements as
specified in Sec. 721.80(f), (k), and (t). It is a significant new use
to import the PMN substance other than in solution, unless in sealed
containers weighing 5 kilograms or less. It is a significant new use to
process the PMN substance in any way that generates a dust, mist, or
aerosol in a non-enclosed process. It is a significant new use to
manufacture the PMN substance longer than 18 months.
(b) Specific requirements. The provision 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) Limitations or revocation of certain modification 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. 721.11518 Sulfonium, triphenyl-, 5-(alkyl) fluoropentane
derivative (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
sulfonium, triphenyl-, 5-(alkyl) fluoropentane derivative (PMN P-19-33)
is subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the PMN substance after they have
been completely reacted or adhered (during the photolithographic
process) onto a semiconductor water 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), (2)(i) and (iii), and (3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (e), (g)(1)(i), (2)(i) through (iii), and (v),
(3)(i) and (ii), and (5). For purposes of Sec. 721.72(e), the
concentration is set at 1.0%. For purposes of Sec. 721.72(g)(1)(i),
required human health hazard statements include acute toxicity, skin
sensitization, serious eye damage, specific target organ toxicity,
neurotoxicity, genetic toxicity, and reproductive toxicity.
(iii) Industrial, commercial, and consumer use. Requirements as
specified in Sec. 721.80(f), (k), and (t). It is a significant new use
to import the PMN substance other than in solution, unless in sealed
containers weighing 5 kilograms or less. It is a significant new use to
process the PMN substance in any way that generates a dust, mist, or
aerosol in a non-enclosed process. It is a significant new use to
manufacture the PMN substance longer than 18 months.
(b) Specific requirements. The provision 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) Limitations or revocation of certain modification 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. 721.11519 Sulfonium, triphenyl-, salt with substituted-alkyl 4-
substituted-benzoate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
sulfonium, triphenyl-, salt with substituted-alkyl 4-substituted-
benzoate (PMN P-17-178) is subject to reporting under this section for
the significant new use 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
the photolithographic process) onto a semiconductor water surface or
similar manufactured article used in the production of semiconductor
technologies.
(2) The significant new use is:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (2)(i) and (iii), and (3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), and (e), (g)(1)(i), (2)(i) through (iii), and
(v), (3)(i) and (ii), and (5). For purposes of Sec. 721.72(e), the
concentration is set at 1.0%. For purposes of Sec. 721.72(g)(1)(i),
required human health hazard statements include acute toxicity, skin
sensitization, serious eye damage, specific target organ toxicity,
neurotoxicity, genetic toxicity, and reproductive toxicity.
(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 PMN substance other than in solution, unless in
sealed containers weighing 5 kilograms or less. It is a significant new
use to process the PMN substance in any way that generates a dust,
mist, or aerosol in a non-enclosed process. It is a significant new use
to manufacture the PMN substance longer than 18 months.
(b) Specific requirements. The provision 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) Limitations or revocation of certain modification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions
[[Page 64292]]
of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.
Sec. 721.11520 Substituted-triphenylsulfonium, inner salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
substituted-triphenylsulfonium, inner salt (PMN P-18-13) is subject to
reporting under this section for the significant new use 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 the photolithographic process)
onto a semiconductor water surface or similar manufactured article used
in the production of semiconductor technologies.
(2) The significant new use is:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (2)(i) and (iii), and (3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (e), (g)(1)(i), (2)(i) through (iii), and (v),
(3)(i) and (ii), and (5). For purposes of Sec. 721.72(e), the
concentration is set at 1.0%. For purposes of Sec. 721.72(g)(1)(i),
required human health hazard statements include acute toxicity, skin
sensitization, serious eye damage, specific target organ toxicity,
neurotoxicity, genetic toxicity, and reproductive toxicity.
(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 PMN substance other than in solution, unless in
sealed containers weighing 5 kilograms or less. It is a significant new
use to process the PMN substance in any way that generates a dust,
mist, or aerosol in a non-enclosed process. It is a significant new use
to manufacture the PMN substance longer than 18 months.
(b) Specific requirements. The provision 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) Limitations or revocation of certain modification 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. 721.11521 Sulfonium, triphenyl-, salt with disubstituted-
heterocyclic compound (1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
sulfonium, triphenyl-, salt with disubstituted-heterocyclic compound
(1:1) (PMN P-18-14) is subject to reporting under this section for the
significant new use 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
the photolithographic process) onto a semiconductor water surface or
similar manufactured article used in the production of semiconductor
technologies.
(2) The significant new use is:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (2)(i) and (iii), and (3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (e), (g)(1)(i), (2)(i) through (iii), and (v),
(3)(i) and (ii), and (5). For purposes of Sec. 721.72(e), the
concentration is set at 1.0%. For purposes of Sec. 721.72(g)(1)(i),
required human health hazard statements include acute toxicity, skin
sensitization, serious eye damage, specific target organ toxicity,
neurotoxicity, genetic toxicity, and reproductive toxicity.
(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 PMN substance other than in solution, unless in
sealed containers weighing 5 kilograms or less. It is a significant new
use to process the PMN substance in any way that generates a dust,
mist, or aerosol in a non-enclosed process. It is a significant new use
to manufacture the PMN substance longer than 18 months.
(b) Specific requirements. The provision 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) Limitations or revocation of certain modification 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. 721.11522 Sulfonium, triphenyl-, salt with 2,4,5-trisubstituted-
benzenesulfonate (1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
sulfonium, triphenyl-, salt with 2,4,5-trisubstituted-benzenesulfonate
(1:1) (PMN P-18-37) is subject to reporting under this section for the
significant new use 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
the photolithographic process) onto a semiconductor water surface or
similar manufactured article used in the production of semiconductor
technologies.
(2) The significant new use is:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (2)(i) and (iii), and (3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (e), (g)(1)(i), (2)(i) through (iii), and (v),
(3)(i) and (ii), and (5). For purposes of Sec. 721.72(e), the
concentration is set at 1.0%. For purposes of Sec. 721.72(g)(1)(i),
required human health hazard statements include acute toxicity, skin
sensitization, serious eye damage, specific target organ toxicity,
neurotoxicity, genetic toxicity, and reproductive toxicity.
(iii) Industrial, commercial, and consumer activities. Requirements
as
[[Page 64293]]
specified in Sec. 721.80(f), (k), and (t). It is a significant new use
to import the PMN substance other than in solution, unless in sealed
containers weighing 5 kilograms or less. It is a significant new use to
process the PMN substance in any way that generates a dust, mist, or
aerosol in a non-enclosed process. It is a significant new use to
manufacture the PMN substance longer than 18 months.
(b) Specific requirements. The provision 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) Limitations or revocation of certain modification 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. 721.11523 Substituted heterocyclic onium compound, salt with
2,2,2-trifluoro-1-(sulfomethyl)-1-(trifluoromethyl)ethyl 3-[(2-methyl-
1-oxo-2-propen-1-yl)oxy]tricyclo[3.3.1.13,7]decane-1-carboxylate (1:1),
polymer with acenaphthylene, 1-ethenyl-4-[(1-
ethylcyclopentyl)oxy]benzene and 4-ethenylphenol, di-Me 2,2'-(1,2-
diazenediyl)bis[2-methylpropanoate]-initiated (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
substituted heterocyclic onium compound, salt with 2,2,2-trifluoro-1-
(sulfomethyl)-1-(trifluoromethyl)ethyl 3-[(2-methyl-1-oxo-2-propen-1-
yl)oxy]tricyclo[3.3.1.13,7]decane-1-carboxylate (1:1), polymer with
acenaphthylene, 1-ethenyl-4-[(1-ethylcyclopentyl)oxy]benzene and 4-
ethenylphenol, di-Me 2,2'-(1,2-diazenediyl)bis[2-methylpropanoate]-
initiated (PMN P-19-78) is subject to reporting under this section for
the significant new use 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
the photolithographic process) onto a semiconductor water surface or
similar manufactured article used in the production of semiconductor
technologies.
(2) The significant new use is:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (2)(i) and (iii), and (3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (e), (g)(1)(i), (2)(i) through (iii), and (v),
(3)(i) and (ii), and (5). For purposes of Sec. 721.72(e), the
concentration is set at 1.0%. For purposes of Sec. 721.72(g)(1)(i),
required human health hazard statements include acute toxicity, skin
sensitization, serious eye damage, specific target organ toxicity,
neurotoxicity, genetic toxicity, and reproductive toxicity.
(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 PMN substance other than in solution, unless in
sealed containers weighing 5 kilograms or less. It is a significant new
use to process the PMN substance in any way that generates a dust,
mist, or aerosol in a non-enclosed process. It is a significant new use
to manufacture the PMN substance longer than 18 months.
(b) Specific requirements. The provision 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) Limitations or revocation of certain modification 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. 721.11524 Substituted heterocyclic onium compound, salt with
2,2,2-trifluoro-1-(sulfomethyl)-1-(trifluoromethyl)ethyl 3-[(2-methyl-
1-oxo-2-propen-1-yl)oxy]tricyclo[3.3.1.13,7]decane-1-carboxylate (1:1),
polymer with acenaphthylene 1-ethenyl-4-[[1-(1-
methylethyl)cyclopentyl]oxy]benzene and 4-ethenylphenol, di-Me 2,2'-
(1,2-diazenediyl)bis[2-methylpropanoate]-initiated (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
substituted heterocyclic onium compound, salt with 2,2,2-trifluoro-1-
(sulfomethyl)-1-(trifluoromethyl)ethyl 3-[(2-methyl-1-oxo-2-propen-1-
yl)oxy]tricyclo[3.3.1.13,7]decane-1-carboxylate (1:1), polymer with
acenaphthylene 1-ethenyl-4-[[1-(1-methylethyl)cyclopentyl]oxy]benzene
and 4-ethenylphenol, di-Me 2,2'-(1,2-diazenediyl)bis[2-
methylpropanoate]-initiated (PMN P-19-79) is subject to reporting under
this section for the significant new use 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 the photolithographic process) onto a semiconductor
water surface or similar manufactured article used in the production of
semiconductor technologies.
(2) The significant new use is:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (2)(i) and (iii), and (3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (e), (g)(1)(i), (2)(i) through (iii), and (v),
(3)(i) and (ii), and (5). For purposes of Sec. 721.72(e), the
concentration is set at 1.0%. For purposes of Sec. 721.72(g)(1)(i),
required human health hazard statements include acute toxicity, skin
sensitization, serious eye damage, specific target organ toxicity,
neurotoxicity, genetic toxicity, and reproductive toxicity.
(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 PMN substance other than in solution, unless in
sealed containers weighing 5 kilograms or less. It is a significant new
use to process the PMN substance in any way that generates a dust,
mist, or aerosol in a non-enclosed process. It is a significant new use
to manufacture the PMN substance longer than 18 months.
(b) Specific requirements. The provision 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) Limitations or revocation of certain modification requirements.
The
[[Page 64294]]
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. 721.11525 Dibenzothiophenium, aryl substituted trifluoro-
hydroxy-(triheterosubstitutedalkyl)alkanoate (1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
dibenzothiophenium, aryl substituted trifluoro-hydroxy-
(triheterosubstitutedalkyl)alkanoate (1:1) (PMN P-19-111) is subject to
reporting under this section for the significant new use 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 the photolithographic process)
onto a semiconductor water surface or similar manufactured article used
in the production of semiconductor technologies.
(2) The significant new use is:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (2)(i) and (iii), and (3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (e), (g)(1)(i), (2)(i) through (iii), and (v),
(3)(i) and (ii), and (5). For purposes of Sec. 721.72(e), the
concentration is set at 1.0%. For purposes of Sec. 721.72(g)(1)(i),
required human health hazard statements include acute toxicity, skin
sensitization, serious eye damage, specific target organ toxicity,
neurotoxicity, genetic toxicity, and reproductive toxicity.
(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 PMN substance other than in solution, unless in
sealed containers weighing 5 kilograms or less. It is a significant new
use to process the PMN substance in any way that generates a dust,
mist, or aerosol in a non-enclosed process. It is a significant new use
to manufacture the PMN substance longer than 18 months.
(b) Specific requirements. The provision 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) Limitations or revocation of certain modification 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. 721.11526 Substituted heterocyclic onium compound, salt with 1-
(difluorosulfomethyl)-2,2,2-trifluoroethyl 3-[(2-methyl-1-oxo-2-propen-
1-yl)oxy]tricyclo[3.3.1.13,7]decane-1-carboxylate (1:1), polymer with
3-ethenylphenol, 1-(1-methylethyl)cyclopentyl 2-methyl-2-propenoate and
1-(7-oxabicyclo[2.2.1]hept-2-yl)cyclopentyl 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 generically identified as
substituted heterocyclic onium compound, salt with 1-
(difluorosulfomethyl)-2,2,2-trifluoroethyl 3-[(2-methyl-1-oxo-2-propen-
1-yl)oxy]tricyclo[3.3.1.13,7]decane-1-carboxylate (1:1), polymer with
3-ethenylphenol, 1-(1-methylethyl)cyclopentyl 2-methyl-2-propenoate and
1-(7-oxabicyclo[2.2.1]hept-2-yl)cyclopentyl 2-methyl-2-propenoate, di-
Me 2,2'-(1,2-diazenediyl)bis[2-methylpropenoate]-initiated (PMN P-19-
112) is subject to reporting under this section for the significant new
use 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 the photolithographic
process) onto a semiconductor water surface or similar manufactured
article used in the production of semiconductor technologies.
(2) The significant new use is:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (2)(i) and (iii), and (3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (e), (g)(1)(i), (2)(i) through (iii), and (v),
(3)(i) and (ii), and (5). For purposes of Sec. 721.72(e), the
concentration is set at 1.0%. For purposes of Sec. 721.72(g)(1)(i),
required human health hazard statements include acute toxicity, skin
sensitization, serious eye damage, specific target organ toxicity,
neurotoxicity, genetic toxicity, and reproductive toxicity.
(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 PMN substance other than in solution, unless in
sealed containers weighing 5 kilograms or less. It is a significant new
use to process the PMN substance in any way that generates a dust,
mist, or aerosol in a non-enclosed process. It is a significant new use
to manufacture the PMN substance longer than 18 months.
(b) Specific requirements. The provision 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) Limitations or revocation of certain modification 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. 721.11527 Sulfonium, triphenyl-, trifluoro-hydroxy-
(triheterosubstitutedalkyl)alkanoate (1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
sulfonium, triphenyl-, trifluoro-hydroxy-
(triheterosubstitutedalkyl)alkanoate (1:1) (PMN P-19-114) is subject to
reporting under this section for the significant new use 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 the photolithographic process)
onto a semiconductor water surface or similar manufactured article used
in the production of semiconductor technologies.
(2) The significant new use is:
(i) Protection in the workplace. Requirements as specified in
[[Page 64295]]
Sec. 721.63(a)(1), (2)(i) and (iii), and (3), and (c). When
determining which persons are reasonably likely to be exposed as
required for Sec. 721.63(a)(1), engineering control measures (e.g.,
enclosure or confinement of the operation, general and local
ventilation) or administrative control measures (e.g., workplace
policies and procedures) shall be considered and implemented to prevent
exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (e), (g)(1)(i), (2)(i) through (iii), and (v),
(3)(i) and (ii), and (5). For purposes of Sec. 721.72(e), the
concentration is set at 1.0%. For purposes of Sec. 721.72(g)(1)(i),
required human health hazard statements include acute toxicity, skin
sensitization, serious eye damage, specific target organ toxicity,
neurotoxicity, genetic toxicity, and reproductive toxicity.
(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 PMN substance other than in solution, unless in
sealed containers weighing 5 kilograms or less. It is a significant new
use to process the PMN substance in any way that generates a dust,
mist, or aerosol in a non-enclosed process. It is a significant new use
to manufacture the PMN substance longer than 18 months.
(b) Specific requirements. The provision 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) Limitations or revocation of certain modification 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. 721.11528 Heterotrisubstituted-bile acid, 1-
(difluorosulfomethyl)-2,2,2-trifluoroethyl ester, ion(1-), (5)-,
triphenylsulfonium (1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
heterotrisubstituted-bile acid, 1-(difluorosulfomethyl)-2,2,2-
trifluoroethyl ester, ion(1-), (5)-, triphenylsulfonium (1:1) (PMN P-
19-133) is subject to reporting under this section for the significant
new use 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 the photolithographic
process) onto a semiconductor water surface or similar manufactured
article used in the production of semiconductor technologies.
(2) The significant new use is:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (2)(i) and (iii), and (3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (e), (g)(1)(i), (2)(i) through (iii), and (v),
(3)(i) and (ii), and (5). For purposes of Sec. 721.72(e), the
concentration is set at 1.0%. For purposes of Sec. 721.72(g)(1)(i),
required human health hazard statements include acute toxicity, skin
sensitization, serious eye damage, specific target organ toxicity,
neurotoxicity, genetic toxicity, and reproductive toxicity.
(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 PMN substance other than in solution, unless in
sealed containers weighing 5 kilograms or less. It is a significant new
use to process the PMN substance in any way that generates a dust,
mist, or aerosol in a non-enclosed process. It is a significant new use
to manufacture the PMN substance longer than 18 months.
(b) Specific requirements. The provision 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) Limitations or revocation of certain modification 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. 721.11529 Aromatic sulfonium tricyclo fluoroalkyl sulfonic acid
salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
aromatic sulfonium tricyclo fluoroalkyl sulfonic acid salt (PMN P-18-
16) 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 PMN substance after they
have been completely reacted or adhered (during the photolithographic
process) onto a semiconductor water 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), (2)(i) and (iii), and (3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (e), (g)(1)(i), (2)(i) through (iii), and (v),
(3)(i) and (ii), and (5). For purposes of Sec. 721.72(e), the
concentration is set at 1.0%. For purposes of Sec. 721.72(g)(1)(i),
required human health hazard statements include acute toxicity, skin
sensitization, serious eye damage, specific target organ toxicity,
neurotoxicity, genetic toxicity, and reproductive toxicity.
(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 PMN substance other than in solution, unless in
sealed containers weighing 5 kilograms or less. It is a significant new
use to use or process the PMN substance in any way that generates a
dust, mist, or aerosol in a non-enclosed process. It is a significant
new use to manufacture the PMN substance longer than 18 months.
(b) Specific requirements. The provision 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) Limitations or revocation of certain modification requirements.
The provisions of Sec. 721.185 apply to this section.
[[Page 64296]]
(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. 721.11530 Substituted, (alkylaromatic)diaromatic salt with
trihalo-[(trihaloalkyl)substituted]substituted alkaneamide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
substituted, (alkylaromatic)diaromatic salt with trihalo-
[(trihaloalkyl)substituted]substituted alkaneamide (PMN P-18-297) is
subject to reporting under this section for the significant new use
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 the photolithographic
process) onto a semiconductor water surface or similar manufactured
article used in the production of semiconductor technologies.
(2) The significant new use is:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (2)(i) and (iii), and (3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (e), (g)(1)(i), (2)(i) through (iii), and (v),
(3)(i) and (ii), and (5). For purposes of Sec. 721.72(e), the
concentration is set at 1.0%. For purposes of Sec. 721.72(g)(1)(i),
required human health hazard statements include acute toxicity, skin
sensitization, serious eye damage, specific target organ toxicity,
neurotoxicity, genetic toxicity, and reproductive toxicity.
(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 PMN substance other than in solution, unless in
sealed containers weighing 5 kilograms or less. It is a significant new
use to process the PMN substance in any way that generates a dust,
mist, or aerosol in a non-enclosed process. It is a significant new use
to manufacture the PMN substance longer than 18 months.
(b) Specific requirements. The provision 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) Limitations or revocation of certain modification 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. 721.11531 Triarylsulfonium substituted
oxatricycloalkyloxycarbonyl dihalo alkane sulfonate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
triarylsulfonium substituted oxatricycloalkyloxycarbonyl dihalo alkane
sulfonate (PMN P-18-311) is subject to reporting under this section for
the significant new use 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
the photolithographic process) onto a semiconductor water surface or
similar manufactured article used in the production of semiconductor
technologies.
(2) The significant new use is:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (2)(i) and (iii), and (3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (e), (g)(1)(i), (2)(i) through (iii), and (v),
(3)(i) and (ii), and (5). For purposes of Sec. 721.72(e), the
concentration is set at 1.0%. For purposes of Sec. 721.72(g)(1)(i),
required human health hazard statements include acute toxicity, skin
sensitization, serious eye damage, specific target organ toxicity,
neurotoxicity, genetic toxicity, and reproductive toxicity.
(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 PMN substance other than in solution, unless in
sealed containers weighing 5 kilograms or less. It is a significant new
use to process the PMN substance in any way that generates a dust,
mist, or aerosol in a non-enclosed process. It is a significant new use
to manufacture the PMN substance longer than 18 months.
(b) Specific requirements. The provision 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) Limitations or revocation of certain modification 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. 721.11532 Substituted triarylsulfonium carbopolycyclic
heteromonocyclic dihalo sulfoacetate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
substituted triarylsulfonium carbopolycyclic heteromonocyclic dihalo
sulfoacetate (PMN P-18-314) is subject to reporting under this section
for the significant new use 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 the photolithographic process) onto a semiconductor water
surface or similar manufactured article used in the production of
semiconductor technologies.
(2) The significant new use is:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (2)(i) and (iii), and (3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (e), (g)(1)(i), (2)(i) through (iii), and (v),
(3)(i) and (ii), and (5). For purposes of Sec. 721.72(e), the
concentration is set at 1.0%. For purposes of Sec. 721.72(g)(1)(i),
required human health hazard statements include acute toxicity, skin
[[Page 64297]]
sensitization, serious eye damage, specific target organ toxicity,
neurotoxicity, genetic toxicity, and reproductive toxicity.
(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 PMN substance other than in solution, unless in
sealed containers weighing 5 kilograms or less. It is a significant new
use to process the PMN substance in any way that generates a dust,
mist, or aerosol in a non-enclosed process. It is a significant new use
to manufacture the PMN substance longer than 18 months.
(b) Specific requirements. The provision 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) Limitations or revocation of certain modification 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. 721.11533 Substituted triarylsulfonium substituted
carbopolycyclic carboxylate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
substituted triarylsulfonium substituted carbopolycyclic carboxylate
(PMN P-18-315) is subject to reporting under this section for the
significant new use 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
the photolithographic process) onto a semiconductor water surface or
similar manufactured article used in the production of semiconductor
technologies.
(2) The significant new use is:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (2)(i) and (iii), and (3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (e), (g)(1)(i), (2)(i) through (iii), and (v),
(3)(i) and (ii), and (5). For purposes of Sec. 721.72(e), the
concentration is set at 1.0%. For purposes of Sec. 721.72(g)(1)(i),
required human health hazard statements include acute toxicity, skin
sensitization, serious eye damage, specific target organ toxicity,
neurotoxicity, genetic toxicity, and reproductive toxicity.
(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 PMN substance other than in solution, unless in
sealed containers weighing 5 kilograms or less. It is a significant new
use to process the PMN substance in any way that generates a dust,
mist, or aerosol in a non-enclosed process. It is a significant new use
to manufacture the PMN substance longer than 18 months.
(b) Specific requirements. The provision 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) Limitations or revocation of certain modification 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. 721.11534 Sulfonium, bis(dihalocarbomonocycle) carbomonocycle,
salt with substituted heteropolycycle dihalo sulfoalkanoate (1:1)
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
sulfonium, bis(dihalocarbomonocycle) carbomonocycle, salt with
substituted heteropolycycle dihalo sulfoalkanoate (1:1) (PMN P-18-304)
is subject to reporting under this section for the significant new use
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 the photolithographic
process) onto a semiconductor water surface or similar manufactured
article used in the production of semiconductor technologies.
(2) The significant new use is:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (2)(i) and (iii), and (3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (e), (g)(1)(i), (2)(i) through (iii), and (v),
(3)(i) and (ii), and (5). For purposes of Sec. 721.72(e), the
concentration is set at 1.0%. For purposes of Sec. 721.72(g)(1)(i),
required human health hazard statements include acute toxicity, skin
sensitization, serious eye damage, specific target organ toxicity,
neurotoxicity, genetic toxicity, and reproductive toxicity.
(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 PMN substance other than in solution, unless in
sealed containers weighing 5 kilograms or less. It is a significant new
use to process the PMN substance in any way that generates a dust,
mist, or aerosol in a non-enclosed process. It is a significant new use
to manufacture the PMN substance longer than 18 months.
(b) Specific requirements. The provision 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) Limitations or revocation of certain modification 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. 721.11535 Heteropolycycle, alkylaromatic-, salt with dihalo-
substituted alkyl carbopolycycle carboxylate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified
heteropolycycle, alkylaromatic-, salt with dihalo-substituted alkyl
carbopolycycle carboxylate (PMN P-18-316) is subject to reporting under
this section for the significant new use described in paragraph (a)(2)
of this section. The requirements of this section do not apply to
quantities of the substance after
[[Page 64298]]
they have been completely reacted or adhered (during the
photolithographic process) onto a semiconductor water surface or
similar manufactured article used in the production of semiconductor
technologies.
(2) The significant new use is:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (2)(i) and (iii), and (3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (e), (g)(1)(i), (2)(i) through (iii), and (v),
(3)(i) and (ii), and (5). For purposes of Sec. 721.72(e), the
concentration is set at 1.0%. For purposes of Sec. 721.72(g)(1)(i),
required human health hazard statements include acute toxicity, skin
sensitization, serious eye damage, specific target organ toxicity,
neurotoxicity, genetic toxicity, and reproductive toxicity.
(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 PMN substance other than in solution, unless in
sealed containers weighing 5 kilograms or less. It is a significant new
use to process the PMN substance in any way that generates a dust,
mist, or aerosol in a non-enclosed process. It is a significant new use
to manufacture the PMN substance longer than 18 months.
(b) Specific requirements. The provision 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) Limitations or revocation of certain modification 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. 721.11536 Sulfonium, triaryl-, salt with polyhalo-4-sulfoalkyl
polycarbocyclic alkane-1-carboxylate (1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
sulfonium, triaryl-, salt with polyhalo-4-sulfoalkyl polycarbocyclic
alkane-1-carboxylate (1:1) (PMN P-18-338) is subject to reporting under
this section for the significant new use 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 the photolithographic process) onto a semiconductor
water surface or similar manufactured article used in the production of
semiconductor technologies.
(2) The significant new use is:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (2)(i) and (iii), and (3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (e), (g)(1)(i), (2)(i) through (iii), and (v),
(3)(i) and (ii), and (5). For purposes of Sec. 721.72(e), the
concentration is set at 1.0%. For purposes of Sec. 721.72(g)(1)(i),
required human health hazard statements include acute toxicity, skin
sensitization, serious eye damage, specific target organ toxicity,
neurotoxicity, genetic toxicity, and reproductive toxicity.
(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 PMN substance other than in solution, unless in
sealed containers weighing 5 kilograms or less. It is a significant new
use to process the PMN substance in any way that generates a dust,
mist, or aerosol in a non-enclosed process. It is a significant new use
to manufacture the PMN substance longer than 18 months.
(b) Specific requirements. The provision 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) Limitations or revocation of certain modification 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. 721.11537 Sulfonium, bis(dihalocarbomonocycle) carbomonocycle,
salt with dihalo substituted alkyl carbopolycyclic carboxylate (1:1)
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
sulfonium, bis(dihalocarbomonocycle) carbomonocycle, salt with dihalo
substituted alkyl carbopolycyclic carboxylate (1:1) (PMN P-19-76) is
subject to reporting under this section for the significant new use
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 the photolithographic
process) onto a semiconductor water surface or similar manufactured
article used in the production of semiconductor technologies.
(2) The significant new use is:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (2)(i) and (iii), and (3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (e), (g)(1)(i), (2)(i) through (iii), and (v),
(3)(i) and (ii), and (5). For purposes of Sec. 721.72(e), the
concentration is set at 1.0%. For purposes of Sec. 721.72(g)(1)(i),
required human health hazard statements include acute toxicity, skin
sensitization, serious eye damage, specific target organ toxicity,
neurotoxicity, genetic toxicity, and reproductive toxicity.
(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 PMN substance other than in solution, unless in
sealed containers weighing 5 kilograms or less. It is a significant new
use to process the PMN substance in any way that generates a dust,
mist, or aerosol in a non-enclosed process. It is a significant new use
to manufacture the PMN substance longer than 18 months.
(b) Specific requirements. The provision of subpart A of this part
apply
[[Page 64299]]
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) Limitations or revocation of certain modification 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. 721.11538 Sulfonium, bis(dihalocarbomonocycle) carbomonocycle,
substituted carbomonocyclic ester (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
sulfonium, bis(dihalocarbomonocycle) carbomonocycle, substituted
carbomonocyclic ester (PMN P-19-115) is subject to reporting under this
section for the significant new use 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 the photolithographic process) onto a semiconductor
water surface or similar manufactured article used in the production of
semiconductor technologies.
(2) The significant new use is:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (2)(i) and (iii), and (3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (e), (g)(1)(i), (2)(i) through (iii), and (v),
(3)(i) and (ii), and (5). For purposes of Sec. 721.72(e), the
concentration is set at 1.0%. For purposes of Sec. 721.72(g)(1)(i),
required human health hazard statements include acute toxicity, skin
sensitization, serious eye damage, specific target organ toxicity,
neurotoxicity, genetic toxicity, and reproductive toxicity.
(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 PMN substance other than in solution, unless in
sealed containers weighing 5 kilograms or less. It is a significant new
use to process the PMN substance in any way that generates a dust,
mist, or aerosol in a non-enclosed process. It is a significant new use
to manufacture the PMN substance longer than 18 months.
(b) Specific requirements. The provision 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) Limitations or revocation of certain modification 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. 721.11539 Heteropolycycle, aromatic-, salt with dihalo-
substituted alkyl carbopolycycle carboxylate (1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
heteropolycycle, aromatic-, salt with dihalo-substituted alkyl
carbopolycycle carboxylate (1:1) (PMN P-19-142) is subject to reporting
under this section for the significant new use 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 the photolithographic process) onto a semiconductor
water surface or similar manufactured article used in the production of
semiconductor technologies.
(2) The significant new use is:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (2)(i) and (iii), and (3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (e), (g)(1)(i), (2)(i) through (iii), and (v),
(3)(i) and (ii), and (5). For purposes of Sec. 721.72(e), the
concentration is set at 1.0%. For purposes of Sec. 721.72(g)(1)(i),
required human health hazard statements include acute toxicity, skin
sensitization, serious eye damage, specific target organ toxicity,
neurotoxicity, genetic toxicity, and reproductive toxicity.
(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 PMN substance other than in solution, unless in
sealed containers weighing 5 kilograms or less. It is a significant new
use to process the PMN substance in any way that generates a dust,
mist, or aerosol in a non-enclosed process. It is a significant new use
to manufacture the PMN substance longer than 18 months.
(b) Specific requirements. The provision 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) Limitations or revocation of certain modification 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. 721.11540 Triarylsulfonium alkylestersulfonate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
triarylsulfonium alkylestersulfonate (PMN P-19-166) 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 PMN substance after they have been
completely reacted or adhered (during the photolithographic process)
onto a semiconductor water 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), (2)(i) and (iii), and (3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
[[Page 64300]]
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (e), (g)(1)(i), (2)(i) through (iii), and (v),
(3)(i) and (ii), and (5). For purposes of Sec. 721.72(e), the
concentration is set at 1.0%. For purposes of Sec. 721.72(g)(1)(i),
required human health hazard statements include acute toxicity, skin
sensitization, serious eye damage, specific target organ toxicity,
neurotoxicity, genetic toxicity, and reproductive toxicity.
(iii) Industrial, commercial, and consumer use. Requirements as
specified in Sec. 721.80(f), (k), and (t). It is a significant new use
to import the PMN substance other than in solution, unless in sealed
containers weighing 5 kilograms or less. It is a significant new use to
use or process the PMN substance in any way that generates a dust,
mist, or aerosol in a non-enclosed process. It is a significant new use
to manufacture the PMN substance longer than 18 months.
(b) Specific requirements. The provision 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) Limitations or revocation of certain modification 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. 721.11541 Halogenated alkylbenzoic acid (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
halogenated alkylbenzoic acid (PMN P-19-168) is subject to reporting
under this section for the significant new use 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), (2)(i) and (iii), and (iv), and (3) through (6), (b), and
(c). When determining which persons are reasonably likely to be exposed
as required for Sec. 721.63(a)(1) and (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(a)(6), the airborne form(s) of the substance
include particulate, gas/vapor (all substances in the gas form),
combination gas/vapor and particulate (gas and liquid/solid physical
states are present; a good example is paint spray mist, which contains
both liquid droplets and vapor). For purposes of Sec. 721.63(b), the
concentration is set at 1.0%.
(A) As an alternative to the respirator requirements in paragraph
(a)(2)(i) of this section, a manufacturer or processor may choose to
follow the new chemical exposure limit (NCEL) provision listed in the
TSCA section 5(e) consent order for this substance. The NCEL is 0.0195
mg/m\3\ as an 8-hour time weighted average. Persons who wish to pursue
NCELs as an alternative to Sec. 721.63 respirator requirements may
request to do so under Sec. 721.30. Persons who Sec. 721.30 requests
to use the NCELs approach that are approved by EPA will be required to
follow NCELs provisions comparable to those contained in the
corresponding TSCA section 5(e) consent order.
(B) [Reserved]
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e), (f), (g)(1)(ii) through (iv), (vi), and (ix)
(eye and skin irritation), (g)(2)(i) through (iv), and (v), and (5).
For purposes of Sec. 721.72(e), the concentration is set at 1.0%. For
purposes of Sec. 721.72(g)(1)(i), required human health hazard
statements include acute toxicity, skin sensitization, serious eye
damage, specific target organ toxicity, neurotoxicity, genetic
toxicity, and reproductive toxicity. For purposes of Sec.
721.72(g)(2)(iv), use respiratory protection or maintain workplace
airborne concentrations at or below an 8-hour time-weighted average of
0.0195 mg/m\3\. 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), (q), and (t). It is a significant new
use to manufacture or process the PMN substance without including the
engineering controls/processes described in the TSCA section 5(e)
consent order for the substance.
(b) Specific requirements. The provision 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) Limitations or revocation of certain modification 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. 721.11542 Halogenated alkylbenzoic acid (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
halogenated alkylbenzoic acid (PMN P-19-169) is subject to reporting
under this section for the significant new use 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), (2)(i) and (iii), and (iv), (3) through (6), (b), and
(c). When determining which persons are reasonably likely to be exposed
as required for Sec. 721.63(a)(1) and (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(a)(6), the airborne form(s) of the substance
include particulate, gas/vapor (all substances in the gas form),
combination gas/vapor and particulate (gas and liquid/solid physical
states are present; a good example is paint spray mist, which contains
both liquid droplets and vapor). For purposes of Sec. 721.63(b), the
concentration is set at 1.0%.
(A) As an alternative to the respirator requirements in paragraph
(a)(2)(i) of this section, a manufacturer or processor may choose to
follow the new chemical exposure limit (NCEL) provision listed in the
TSCA section 5(e) consent order for this substance. The NCEL is 0.0195
mg/m\3\ as an 8-hour time weighted average. Persons who wish to pursue
NCELs as an alternative to Sec. 721.63 respirator requirements may
request to do so under Sec. 721.30. Persons who Sec. 721.30 requests
to use the NCELs approach that are approved by EPA will be required to
follow NCELs provisions
[[Page 64301]]
comparable to those contained in the corresponding TSCA section 5(e)
consent order.
(B) [Reserved]
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e), (f), (g)(1)(ii) through (iv), (vi), and (ix)(eye
and skin irritation), (g)(2)(i) through (v), and (5). For purposes of
Sec. 721.72(e), the concentration is set at 1.0%. For purposes of
Sec. 721.72(g)(1)(i), required human health hazard statements include
acute toxicity, skin sensitization, serious eye damage, specific target
organ toxicity, neurotoxicity, genetic toxicity, and reproductive
toxicity. For purposes of Sec. 721.72(g)(2)(iv), use respiratory
protection or maintain workplace airborne concentrations at or below an
8-hour time-weighted average of 0.0195 mg/m\3\. 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), (q), and (t). It is a significant new
use to manufacture or process the PMN substance without including the
engineering controls/processes described in the TSCA section 5(e)
consent order for the substance.
(b) Specific requirements. The provision 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) Limitations or revocation of certain modification 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. 721.11543 Halogenated benzoic acid (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
halogenated benzoic acid (PMN P-19-171) is subject to reporting under
this section for the significant new use 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), (2)(i) and (iii), and (iv), (3) through (6), and (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(a)(6), the airborne form(s) of the substance
include particulate, gas/vapor (all substances in the gas form),
combination gas/vapor and particulate (gas and liquid/solid physical
states are present; a good example is paint spray mist, which contains
both liquid droplets and vapor). For purposes of Sec. 721.63(b), the
concentration is set at 1.0%.
(A) As an alternative to the respirator requirements in paragraph
(a)(2)(i) of this section, a manufacturer or processor may choose to
follow the new chemical exposure limit (NCEL) provision listed in the
TSCA section 5(e) consent order for this substance. The NCEL is 0.0195
mg/m\3\ as an 8-hour time weighted average. Persons who wish to pursue
NCELs as an alternative to Sec. 721.63 respirator requirements may
request to do so under Sec. 721.30. Persons who Sec. 721.30 requests
to use the NCELs approach that are approved by EPA will be required to
follow NCELs provisions comparable to those contained in the
corresponding TSCA section 5(e) consent order.
(B) [Reserved]
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e), (f), (g)(1)(ii) through (iv), (vi), and (ix)(eye
and skin irritation), (g)(2)(i) through (v), and (5). For purposes of
Sec. 721.72(e), the concentration is set at 1.0%. For purposes of
Sec. 721.72(g)(1)(i), required human health hazard statements include
acute toxicity, skin sensitization, serious eye damage, specific target
organ toxicity, neurotoxicity, genetic toxicity, and reproductive
toxicity. For purposes of Sec. 721.72(g)(2)(iv), use respiratory
protection or maintain workplace airborne concentrations at or below an
8-hour time-weighted average of 0.0195 mg/m\3\. 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), (q), and (t). It is a significant new
use to manufacture or process the PMN substance without including the
engineering controls/processes described in the TSCA section 5(e)
consent order for the substance.
(b) Specific requirements. The provision 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) Limitations or revocation of certain modification 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. 721.11544 Halogenated benzoic acid (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
halogenated benzoic acid (PMN P-19-172) is subject to reporting under
this section for the significant new use 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), (2)(i) and (iii), and (iv), and (3) through (6), and (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(a)(6), the airborne
form(s) of the substance include particulate, gas/vapor (all substances
in the gas form), combination gas/vapor and particulate (gas and
liquid/solid physical states are present; a good example is paint spray
mist, which contains both liquid droplets and vapor). For purposes of
Sec. 721.63(b), the concentration is set at 1.0%.
(A) As an alternative to the respirator requirements in paragraph
(a)(2)(i) of this section, a manufacturer or processor may choose to
follow the new chemical exposure limit (NCEL) provision listed in the
TSCA section 5(e) consent order
[[Page 64302]]
for this substance. The NCEL is 0.0195 mg/m\3\ as an 8-hour time
weighted average. Persons who wish to pursue NCELs as an alternative to
Sec. 721.63 respirator requirements may request to do so under Sec.
721.30. Persons who Sec. 721.30 requests to use the NCELs approach
that are approved by EPA will be required to follow NCELs provisions
comparable to those contained in the corresponding TSCA section 5(e)
consent order.
(B) [Reserved]
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e), (f), (g)(1)(ii) through (iv), (vi), (ix)(eye and
skin irritation), (g)(2)(i) through (v), and (5). For purposes of Sec.
721.72(e), the concentration is set at 1.0%. For purposes of Sec.
721.72(g)(1)(i), required human health hazard statements include acute
toxicity, skin sensitization, serious eye damage, specific target organ
toxicity, neurotoxicity, genetic toxicity, and reproductive toxicity.
For purposes of Sec. 721.72(g)(2)(iv), use respiratory protection or
maintain workplace airborne concentrations at or below an 8-hour time-
weighted average of 0.0195 mg/m\3\. 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), (q), and (t). It is a significant new
use to manufacture or process the PMN substance without including the
engineering controls/processes described in the TSCA section 5(e)
consent order for the substance.
(b) Specific requirements. The provision 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) Limitations or revocation of certain modification 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. 721.11545 Halogenated benzoic acid (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
halogenated benzoic acid (PMN P-19-173) is subject to reporting under
this section for the significant new use 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), (2)(i) and (iii), and (iv), and (3) through (6), and (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(a)(6), the airborne
form(s) of the substance include particulate, gas/vapor (all substances
in the gas form), combination gas/vapor and particulate (gas and
liquid/solid physical states are present; a good example is paint spray
mist, which contains both liquid droplets and vapor). For purposes of
Sec. 721.63(b), the concentration is set at 1.0%.
(A) As an alternative to the respirator requirements in paragraph
(a)(2)(i) of this section, a manufacturer or processor may choose to
follow the new chemical exposure limit (NCEL) provision listed in the
TSCA section 5(e) consent order for this substance. The NCEL is 0.0195
mg/m\3\ as an 8-hour time weighted average. Persons who wish to pursue
NCELs as an alternative to Sec. 721.63 respirator requirements may
request to do so under Sec. 721.30. Persons who Sec. 721.30 requests
to use the NCELs approach that are approved by EPA will be required to
follow NCELs provisions comparable to those contained in the
corresponding TSCA section 5(e) consent order.
(B) [Reserved]
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e), (f), (g)(1)(ii) through (iv), (vi), and (ix)(eye
and skin irritation), (g)(2)(i) through (v), and (5). For purposes of
Sec. 721.72(e), the concentration is set at 1.0%. For purposes of
Sec. 721.72(g)(1)(i), required human health hazard statements include
acute toxicity, skin sensitization, serious eye damage, specific target
organ toxicity, neurotoxicity, genetic toxicity, and reproductive
toxicity. For purposes of Sec. 721.72(g)(2)(iv), use respiratory
protection or maintain workplace airborne concentrations at or below an
8-hour time-weighted average of 0.0195 mg/m\3\. 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), (q), and (t). It is a significant new
use to manufacture or process the PMN substance without including the
engineering controls/processes described in the TSCA section 5(e)
consent order for the substance.
(b) Specific requirements. The provision 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) Limitations or revocation of certain modification 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. 721.11546 Halogenated alkylbenzoic acid (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
halogenated alkylbenzoic acid (PMN P-19-175) is subject to reporting
under this section for the significant new use 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), (2)(i) and (iii), and (iv), and (3) through (6), and (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(a)(6), the airborne
form(s) of the substance include particulate, gas/vapor (all substances
in the gas form), combination gas/vapor and particulate (gas and
liquid/solid physical states are present; a good example is paint spray
mist, which contains both liquid droplets and vapor). For purposes of
[[Page 64303]]
Sec. 721.63(b), the concentration is set at 1.0%.
(A) As an alternative to the respirator requirements in paragraph
(a)(2)(i) of this section, a manufacturer or processor may choose to
follow the new chemical exposure limit (NCEL) provision listed in the
TSCA section 5(e) consent order for this substance. The NCEL is 0.0195
mg/m\3\ as an 8-hour time weighted average. Persons who wish to pursue
NCELs as an alternative to Sec. 721.63 respirator requirements may
request to do so under Sec. 721.30. Persons who Sec. 721.30 requests
to use the NCELs approach that are approved by EPA will be required to
follow NCELs provisions comparable to those contained in the
corresponding TSCA section 5(e) consent order.
(B) [Reserved]
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e), (f), (g)(1)(ii) through (iv), (vi), and (ix)
(eye and skin irritation), (g)(2)(i) through (v), and (5). For purposes
of Sec. 721.72(e), the concentration is set at 1.0%. For purposes of
Sec. 721.72(g)(1)(i), required human health hazard statements include
acute toxicity, skin sensitization, serious eye damage, specific target
organ toxicity, neurotoxicity, genetic toxicity, and reproductive
toxicity. For purposes of Sec. 721.72(g)(2)(iv), use respiratory
protection or maintain workplace airborne concentrations at or below an
8-hour time-weighted average of 0.0195 mg/m\3\. 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), (q), and (t). It is a significant new
use to manufacture or process the PMN substance without including the
engineering controls/processes described in the TSCA section 5(e)
consent order for the substance.
(b) Specific requirements. The provision 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) Limitations or revocation of certain modification 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. 721.11547 Halogenated alkylbenzoic acid (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
halogenated alkylbenzoic acid (PMN P-19-176) is subject to reporting
under this section for the significant new use 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), (2)(i) and (iii), and (iv), and (3) through (6), and (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(a)(6), the airborne
form(s) of the substance include particulate, gas/vapor (all substances
in the gas form), combination gas/vapor and particulate (gas and
liquid/solid physical states are present; a good example is paint spray
mist, which contains both liquid droplets and vapor). For purposes of
Sec. 721.63(b), the concentration is set at 1.0%.
(A) As an alternative to the respirator requirements in paragraph
(a)(2)(i) of this section, a manufacturer or processor may choose to
follow the new chemical exposure limit (NCEL) provision listed in the
TSCA section 5(e) consent order for this substance. The NCEL is 0.0195
mg/m\3\ as an 8-hour time weighted average. Persons who wish to pursue
NCELs as an alternative to Sec. 721.63 respirator requirements may
request to do so under Sec. 721.30. Persons who Sec. 721.30 requests
to use the NCELs approach that are approved by EPA will be required to
follow NCELs provisions comparable to those contained in the
corresponding TSCA section 5(e) consent order.
(B) [Reserved]
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e), (f), (g)(1)(ii) through (iv), (vi), and (ix)
(eye and skin irritation), (g)(2)(i) through (v), and (5). For purposes
of Sec. 721.72(e), the concentration is set at 1.0%. For purposes of
Sec. 721.72(g)(1)(i), required human health hazard statements include
acute toxicity, skin sensitization, serious eye damage, specific target
organ toxicity, neurotoxicity, genetic toxicity, and reproductive
toxicity. For purposes of Sec. 721.72(g)(2)(iv), use respiratory
protection or maintain workplace airborne concentrations at or below an
8-hour time-weighted average of 0.0195 mg/m\3\. 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), (q), and (t). It is a significant new
use to manufacture or process the PMN substance without including the
engineering controls/processes described in the TSCA section 5(e)
consent order for the substance.
(b) Specific requirements. The provision 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) Limitations or revocation of certain modification 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. 721.11548 Halogenated alkylbenzoic acid (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
halogenated alkylbenzoic acid (PMN P-19-177) is subject to reporting
under this section for the significant new use 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), (2)(i) and (iii), and (iv), and (3) through (6), and (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
[[Page 64304]]
Sec. 721.63(a)(6), the airborne form(s) of the substance include
particulate, gas/vapor (all substances in the gas form), combination
gas/vapor and particulate (gas and liquid/solid physical states are
present; a good example is paint spray mist, which contains both liquid
droplets and vapor). For purposes of Sec. 721.63(b), the concentration
is set at 1.0%.
(A) As an alternative to the respirator requirements in paragraph
(a)(2)(i) of this section, a manufacturer or processor may choose to
follow the new chemical exposure limit (NCEL) provision listed in the
TSCA section 5(e) consent order for this substance. The NCEL is 0.0195
mg/m\3\ as an 8-hour time weighted average. Persons who wish to pursue
NCELs as an alternative to Sec. 721.63 respirator requirements may
request to do so under Sec. 721.30. Persons who Sec. 721.30 requests
to use the NCELs approach that are approved by EPA will be required to
follow NCELs provisions comparable to those contained in the
corresponding TSCA section 5(e) consent order.
(B) [Reserved]
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e), (f), (g)(1)(ii) through (iv), (vi), and (ix)
(eye and skin irritation), (g)(2)(i) through (v), and (5). For purposes
of Sec. 721.72(e), the concentration is set at 1.0%. For purposes of
Sec. 721.72(g)(1)(i), required human health hazard statements include
acute toxicity, skin sensitization, serious eye damage, specific target
organ toxicity, neurotoxicity, genetic toxicity, and reproductive
toxicity. For purposes of Sec. 721.72(g)(2)(iv), use respiratory
protection or maintain workplace airborne concentrations at or below an
8-hour time-weighted average of 0.0195 mg/m\3\. 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), (q), and (t). It is a significant new
use to manufacture or process the PMN substance without including the
engineering controls/processes described in the TSCA section 5(e)
consent order for the substance.
(b) Specific requirements. The provision 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) Limitations or revocation of certain modification 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. 721.11549 Halogenated alkylbenzoic acid (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
halogenated alkylbenzoic acid (PMN P-19-178) is subject to reporting
under this section for the significant new use 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), (2)(i) and (iii), and (iv), and (3) through (6), (b), and
(c). When determining which persons are reasonably likely to be exposed
as required for Sec. 721.63(a)(1) and (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(a)(6), the airborne form(s) of the substance
include particulate, gas/vapor (all substances in the gas form),
combination gas/vapor and particulate (gas and liquid/solid physical
states are present; a good example is paint spray mist, which contains
both liquid droplets and vapor). For purposes of Sec. 721.63(b), the
concentration is set at 1.0%.
(A) As an alternative to the respirator requirements in paragraph
(a)(2)(i) of this section, a manufacturer or processor may choose to
follow the new chemical exposure limit (NCEL) provision listed in the
TSCA section 5(e) consent order for this substance. The NCEL is 0.0195
mg/m\3\ as an 8-hour time weighted average. Persons who wish to pursue
NCELs as an alternative to Sec. 721.63 respirator requirements may
request to do so under Sec. 721.30. Persons who Sec. 721.30 requests
to use the NCELs approach that are approved by EPA will be required to
follow NCELs provisions comparable to those contained in the
corresponding TSCA section 5(e) consent order.
(B) [Reserved]
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e), (f), (g)(1)(ii) through (iv), (vi), and (ix)
(eye and skin irritation), (g)(2)(i) through (v), and (5). For purposes
of Sec. 721.72(e), the concentration is set at 1.0%. For purposes of
Sec. 721.72(g)(1)(i), required human health hazard statements include
acute toxicity, skin sensitization, serious eye damage, specific target
organ toxicity, neurotoxicity, genetic toxicity, and reproductive
toxicity. For purposes of Sec. 721.72(g)(2)(iv), use respiratory
protection or maintain workplace airborne concentrations at or below an
8-hour time-weighted average of 0.0195 mg/m\3\. 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), (q), and (t). It is a significant new
use to manufacture or process the PMN substance without including the
engineering controls/processes described in the TSCA section 5(e)
consent order for the substance.
(b) Specific requirements. The provision 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) Limitations or revocation of certain modification 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. 721.11550 Halogenated alkylbenzoic acid (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
halogenated alkylbenzoic acid (PMN P-19-179) is subject to reporting
under this section for the significant new use 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), (2)(i) and (iii), and (iv), and (3) through (6), and (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
[[Page 64305]]
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(a)(6), the airborne
form(s) of the substance include particulate, gas/vapor (all substances
in the gas form), combination gas/vapor and particulate (gas and
liquid/solid physical states are present; a good example is paint spray
mist, which contains both liquid droplets and vapor). For purposes of
Sec. 721.63(b), the concentration is set at 1.0%.
(A) As an alternative to the respirator requirements in paragraph
(a)(2)(i) of this section, a manufacturer or processor may choose to
follow the new chemical exposure limit (NCEL) provision listed in the
TSCA section 5(e) consent order for this substance. The NCEL is 0.0195
mg/m\3\ as an 8-hour time weighted average. Persons who wish to pursue
NCELs as an alternative to Sec. 721.63 respirator requirements may
request to do so under Sec. 721.30. Persons who Sec. 721.30 requests
to use the NCELs approach that are approved by EPA will be required to
follow NCELs provisions comparable to those contained in the
corresponding TSCA section 5(e) consent order.
(B) [Reserved]
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e), (f), (g)(1)(ii) through (iv), (vi), and (ix)
(eye and skin irritation), (g)(2)(i) through (v), and (5). For purposes
of Sec. 721.72(e), the concentration is set at 1.0%. For purposes of
Sec. 721.72(g)(1)(i), required human health hazard statements include
acute toxicity, skin sensitization, serious eye damage, specific target
organ toxicity, neurotoxicity, genetic toxicity, and reproductive
toxicity. For purposes of Sec. 721.72(g)(2)(iv), use respiratory
protection or maintain workplace airborne concentrations at or below an
8-hour time-weighted average of 0.0195 mg/m\3\. 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), (q), and (t). It is a significant new
use to manufacture or process the PMN substance without including the
engineering controls/processes described in the TSCA section 5(e)
consent order for the substance.
(b) Specific requirements. The provision 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) Limitations or revocation of certain modification 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. 721.11551 Halogenated sodium benzoate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
halogenated sodium benzoate (PMN P-19-180) is subject to reporting
under this section for the significant new use described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e), (f), (g)(1)(ii) through (iv), (vi), and (ix)
(eye and skin irritation), (g)(2)(i) through (iii), and (5). For
purposes of Sec. 721.72(e), the concentration is set at 1.0%. For
purposes of Sec. 721.72(g)(1)(i), required human health hazard
statements include acute toxicity, skin sensitization, serious eye
damage, specific target organ toxicity, neurotoxicity, genetic
toxicity, and reproductive toxicity. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (q). It is a significant new use to
manufacture or process the PMN substance without including the
engineering controls/processes described in the TSCA section 5(e)
consent order for the substance. It is a significant new use to
manufacture or use the PMN substance other than in liquid formulations.
(b) Specific requirements. The provision of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (f) through (i) are applicable to
manufacturers and processors of this substance.
(2) Limitations or revocation of certain modification 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)(ii) of
this section.
Sec. 721.11552 Halogenated sodium benzoate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
halogenated sodium benzoate (PMN P-19-181) is subject to reporting
under this section for the significant new use described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e), (f), (g)(1)(ii) through (iv), (vi), and (ix)
(eye and skin irritation), (g)(2)(i) through (iii), and (5). For
purposes of Sec. 721.72(e), the concentration is set at 1.0%. For
purposes of Sec. 721.72(g)(1)(i), required human health hazard
statements include acute toxicity, skin sensitization, serious eye
damage, specific target organ toxicity, neurotoxicity, genetic
toxicity, and reproductive toxicity. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (q). It is a significant new use to
manufacture or process the PMN substance without including the
engineering controls/processes described in the TSCA section 5(e)
consent order for the substance. It is a significant new use to
manufacture or use the PMN substance other than in liquid formulations.
(b) Specific requirements. The provision of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (f) through (i) are applicable to
manufacturers and processors of this substance.
(2) Limitations or revocation of certain modification 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)(ii) of
this section.
[[Page 64306]]
Sec. 721.11553 Halogenated sodium benzoate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
halogenated sodium benzoate (PMN P-19-182) is subject to reporting
under this section for the significant new use described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e), (f), (g)(1)(ii) through (iv), (vi), and (ix)
(eye and skin irritation), (g)(2)(i) through (iii), and (5). For
purposes of Sec. 721.72(e), the concentration is set at 1.0%. For
purposes of Sec. 721.72(g)(1)(i), required human health hazard
statements include acute toxicity, skin sensitization, serious eye
damage, specific target organ toxicity, neurotoxicity, genetic
toxicity, and reproductive toxicity. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (q). It is a significant new use to
manufacture or process the PMN substance without including the
engineering controls/processes described in the TSCA section 5(e)
consent order for the substance. It is a significant new use to
manufacture or use the PMN substance other than in liquid formulations.
(b) Specific requirements. The provision of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (f) through (i) are applicable to
manufacturers and processors of this substance.
(2) Limitations or revocation of certain modification 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)(ii) of
this section.
Sec. 721.11554 Halogenated sodium alkylbenzoate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
halogenated sodium alkylbenzoate (PMN P-19-184) is subject to reporting
under this section for the significant new use described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e), (f), (g)(1)(ii) through (iv), (vi), and (ix)
(eye and skin irritation), (g)(2)(i) through (iii), and (5). For
purposes of Sec. 721.72(e), the concentration is set at 1.0%. For
purposes of Sec. 721.72(g)(1)(i), required human health hazard
statements include acute toxicity, skin sensitization, serious eye
damage, specific target organ toxicity, neurotoxicity, genetic
toxicity, and reproductive toxicity. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (q). It is a significant new use to
manufacture or process the PMN substance without including the
engineering controls/processes described in the TSCA section 5(e)
consent order for the substance. It is a significant new use to
manufacture or use the PMN substance other than in liquid formulations.
(b) Specific requirements. The provision of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (f) through (i) are applicable to
manufacturers and processors of this substance.
(2) Limitations or revocation of certain modification 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)(ii) of
this section.
Sec. 721.11555 Halogenated sodium alkylbenzoate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
halogenated sodium alkylbenzoate (PMN P-19-187) is subject to reporting
under this section for the significant new use described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e), (f), (g)(1)(ii) through (iv), (vi), and (ix)
(eye and skin irritation), (g)(2)(i) through (iii), and (5). For
purposes of Sec. 721.72(e), the concentration is set at 1.0%. For
purposes of Sec. 721.72(g)(1)(i), required human health hazard
statements include acute toxicity, skin sensitization, serious eye
damage, specific target organ toxicity, neurotoxicity, genetic
toxicity, and reproductive toxicity. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (q). It is a significant new use to
manufacture or process the PMN substance without including the
engineering controls/processes described in the TSCA section 5(e)
consent order for the substance. It is a significant new use to
manufacture or use the PMN substance other than in liquid formulations.
(b) Specific requirements. The provision of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (f) through (i) are applicable to
manufacturers and processors of this substance.
(2) Limitations or revocation of certain modification 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)(ii) of
this section.
[FR Doc. 2020-21471 Filed 10-8-20; 8:45 am]
BILLING CODE 6560-50-P
