Significant New Use Rules on Certain Chemical Substances (21-1.5e), 31239-31262 [2021-12147]
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Federal Register / Vol. 86, No. 111 / Friday, June 11, 2021 / Proposed Rules
Because this rule proposed to authorize
pre-existing State rules which are at
least equivalent to, and no less stringent
than existing federal requirements, and
imposes no additional requirements
beyond those imposed by State law, and
there are no anticipated significant
adverse human health or environmental
effects, the proposed rule is not subject
to Executive Order 12898.
List of Subjects in 40 CFR Parts 271
Environmental protection,
Administrative practice and procedure,
Confidential business information,
Hazardous waste, Hazardous waste
transportation, Indian lands,
Intergovernmental relations, Penalties,
Reporting and recordkeeping
requirements.
Authority: This action is issued under the
authority of sections 2002(a), 3006, and
7004(b) of the Solid Waste Disposal Act as
amended 42 U.S.C. 6912(a), 6926, 6974(b).
Dated: June 4, 2021.
David Gray,
Acting Regional Administrator, Region 6.
[FR Doc. 2021–12238 Filed 6–10–21; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Parts 721 and 725
[EPA–HQ–OPPT–2020–0588; FRL–10022–
56]
RIN 2070–AB27
Significant New Use Rules on Certain
Chemical Substances (21–1.5e)
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
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SUPPLEMENTARY INFORMATION:
EPA is proposing significant
new use rules (SNURs) under the Toxic
Substances Control Act (TSCA) for
chemical substances that were the
subject of premanufacture notices
(PMNs) and a Microbial Commercial
Activity Notice (MCAN), and are also
subject to Orders issued by EPA
pursuant to TSCA. The SNURs require
persons who intend to manufacture
(defined by statute to include import) or
process any of these chemical
substances for an activity that is
proposed as a significant new use by
this rule to notify EPA at least 90 days
before commencing that activity. The
required notification initiates EPA’s
evaluation of the use, under the
conditions of use for that chemical
substance, within the applicable review
period. Persons may not commence
manufacture or processing for the
SUMMARY:
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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 July 12, 2021.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPPT–2020–0588,
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, New Chemicals Division
(7405M), Office of Pollution Prevention
and Toxics, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460–0001; telephone
number: (202) 564–4163; email address:
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.
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
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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 or
40 CFR 725.920 (for the microorganism),
any persons who export or intend to
export a chemical substance that is the
subject of this proposed rule on or after
July 12, 2021 are subject to the export
notification provisions of TSCA section
12(b) (15 U.S.C. 2611(b)) (see 40 CFR
721.20), and must comply with the
export notification requirements in 40
CFR part 707, subpart D.
B. What should I consider as I prepare
my comments for EPA?
1. Submitting CBI. Do not submit this
information to EPA through
regulations.gov or email. Clearly mark
the part or all of the information that
you claim to be CBI. For CBI
information in a disk or CD–ROM that
you mail to EPA, mark the outside of the
disk or CD–ROM as CBI and then
identify electronically within the disk or
CD–ROM the specific information that
is claimed as CBI. In addition to one
complete version of the comment that
includes information claimed as CBI, a
copy of the comment that does not
contain the information claimed as CBI
must be submitted for inclusion in the
public docket. Information so marked
will not be disclosed except in
accordance with procedures set forth in
40 CFR part 2.
2. Tips for preparing your comments.
When preparing and submitting your
comments, see the commenting tips at
https://www.epa.gov/dockets/
commenting-epa-dockets.
II. Background
A. What action is the Agency taking?
EPA is proposing these SNURs under
TSCA section 5(a)(2) (15 U.S.C.
2604(a)(2)) for chemical substances that
were the subject of PMNs and an
MCAN. 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.
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Federal Register / Vol. 86, No. 111 / Friday, June 11, 2021 / Proposed Rules
The docket for these proposed
SNURs, identified as docket ID number
EPA–HQ–OPPT–2020–0588, 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 and (for
microorganisms) 40 CFR part 725,
subpart L. These provisions describe
persons subject to the rule,
recordkeeping requirements,
exemptions to reporting requirements,
and applicability of the rule to uses
occurring before the effective date of the
rule. Provisions relating to user fees
appear at 40 CFR part 700. Pursuant to
40 CFR 721.1(c), persons subject to
these SNURs must comply with the
same significant new use notice (SNUN)
requirements and EPA regulatory
procedures as submitters of PMNs under
TSCA section 5(a)(1)(A). These
requirements include the information
submission requirements of TSCA
sections 5(b) and 5(d)(1), the
exemptions authorized by TSCA
sections 5(h)(1), (h)(2), (h)(3), and (h)(5),
and the regulations at 40 CFR part 720.
Once EPA receives a SNUN and before
the manufacture or processing for the
significant new use can commence, EPA
must either determine that the use is not
likely to present an unreasonable risk of
injury under the conditions of use for
the chemical substance or take such
regulatory action as is associated with
an alternative determination. If EPA
determines that the use is not likely to
present an unreasonable risk, EPA is
required under TSCA section 5(g) to
make public, and submit for publication
in the Federal Register, a statement of
EPA’s findings.
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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
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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 and
MCAN 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.
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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 and in 40 CFR part
725, subpart M (for the microorganism).
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 or MCAN 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).
• Effective date of and basis for the
TSCA Order.
• Potentially Useful Information.
• CFR citation assigned in the
regulatory text section of the proposed
rule.
The chemicals subject to these
proposed SNURs are as follows:
PMN Number: P–16–167
Chemical Name: Hindered amine
alkyl ester compounds (generic).
CAS Number: Not available.
Effective Date of TSCA Order: April
24, 2020.
Basis for TSCA Order: The PMN states
that the use will be as a light stabilizer
for plastic articles. Based on submitted
test data, EPA has identified concerns
for dermal irritation and sensitization.
Based on comparison to analogous
aliphatic amines, EPA predicts that
toxicity to aquatic organisms may occur
at concentrations that exceed 1 ppb. The
Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I),
based on a finding that in the absence
of sufficient information to permit a
reasoned evaluation, the substance may
present an unreasonable risk of injury to
human health or the environment. To
protect against these risks, the Order
requires:
• Use of personal protective
equipment where there is a potential for
dermal exposure;
• Use of a National Institute for
Occupational Safety and Health
(NIOSH)-certified respirator with an
Assigned Protection Factor (APF) of at
least 50 where there is a potential for
inhalation exposure;
• Establishment of a hazard
communication program, including
human health precautionary statements
on each label and in the SDS; and
• No release of the PMN substance
resulting in surface water
concentrations that exceed 1 ppb.
The proposed SNUR would designate
as a ‘‘significant new use’’ the absence
of these protective measures.
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Potentially Useful Information: EPA
has determined that certain information
may be potentially useful in support of
a request by the PMN submitter to
modify the Order, or if a manufacturer
or processor is considering submitting a
SNUN for a significant new use that will
be designated by this SNUR. EPA has
determined that the results of chronic
aquatic toxicity and reproduction/
developmental toxicity screening testing
may be potentially useful to characterize
the human health and environmental
effects of the PMN substance. Although
the Order does not require these tests,
the Order’s restrictions remain in effect
until the Order is modified or revoked
by EPA based on submission of this or
other relevant information.
CFR Citation: 40 CFR 721.11571.
PMN Numbers: P–16–419, P–16–423,
and P–16–424
Chemical Names: N-alkyl-dialkyl
piperidine (generic) (P–16–419),
Tetraalkylpiperidinium halide (generic)
(P–16–423), and Tetraalkylpiperidinium
hydroxide (generic) (P–16–424).
CAS Numbers: Not available.
Effective Date of TSCA Order: April
15, 2020.
Basis for TSCA Order: The PMNs state
that the generic (non-confidential) uses
will be as an intermediate (P–16–419
and P–16–423) and as a directing agent
(P–16–424). Based on comparison to
analogous chemical substances, EPA has
identified concerns for acute toxicity,
corrosion, systemic and respiratory
effects (P–16–419). Based on
comparison to analogous chemical
substances and the high pH, EPA has
identified concerns for acute oral
toxicity, developmental/reproductive
toxicity, neurotoxicity, renal effects, and
corrosion to all tissues (P–16–423 and
P–16–424). Based on comparison to
analogous chemical substances, EPA
predicts that toxicity to aquatic
organisms may occur at concentrations
that exceed 286 ppb for P–16–419 and
20 ppb for P–16–423 and P–16–424. 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. The
Order was also issued under TSCA
sections 5(a)(3)(B)(ii)(II) and
5(e)(1)(A)(ii)(II), based on a finding that
the substance which was the subject of
P–16–424 is or will be produced in
substantial quantities and that the
substance either enters or may
reasonably be anticipated to enter the
environment in substantial quantities,
or there is or may be a significant (or
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substantial) human exposure to the
substance. To protect against these risks,
the Order requires:
• Use of personal protective
equipment where there is a potential for
dermal exposure;
• Use of a NIOSH-certified respirator
with an APF of at least 10 where there
is a potential for inhalation exposure
(P–16–419);
• Establishment and use of a hazard
communication program, including
human health precautionary statements
on each label and in the SDS;
• Use of P–16–419 only as a sitelimited intermediate;
• Use of P–16–423 only as an
intermediate;
• Use of P–16–424 only for the
confidential use allowed in the Order;
and
• No release of the PMN substances
resulting in surface water
concentrations that exceed 286 ppb (P–
16–419) or 20 ppb (P–16–423 and P–16–
424).
The proposed SNUR would designate
as a ‘‘significant new use’’ the absence
of these protective measures.
Potentially Useful Information: EPA
as determined that certain information
may be potentially useful in support of
a request by the PMN submitter to
modify the Order, or if a manufacturer
or processor is considering submitting a
SNUN for a significant new use that will
be designated by this SNUR. EPA has
determined that the results of aquatic
toxicity and specific target organ
toxicity testing may be potentially
useful to characterize the human health
and environmental effects of the PMN
substances. Additionally, the results of
reproductive toxicity testing may be
potentially useful to characterize the
human health effects of PMNs P–16–423
and P–16–424. Although the Order does
not require these tests, the Order’s
restrictions remain in effect until the
Order is modified or revoked by EPA
based on submission of this or other
relevant information.
CFR Citations: 40 CFR 721.11572 (P–
16–419), 40 CFR 721.11573 (P–16–423),
and 40 CFR 721.11574 (P–16–424).
PMN Numbers: P–17–235 and P–18–226
Chemical Names: Amidoamino
quaternary ammonium salt (generic) (P–
17–235), and Tri alkyl, mono alkoxy,
fatty acid ester, ammonium salt
(generic) (P–18–226).
CAS Numbers: Not available.
Effective Date of TSCA Order: April
22, 2020.
Basis for TSCA Order: The PMNs state
that the generic (non-confidential) use
of the PMN substances will be as an
anti-agglomerant. Based on the
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surfactant properties of the compounds
and comparison to analogous
substances, EPA has identified concerns
for surfactant effects on the lungs,
irritation and possible corrosion to the
eyes, skin, and respiratory tract. Based
on comparison to analogous substances,
EPA has also identified concerns for
developmental toxicity. Based on
comparison to analogous polycationic
polymers, EPA predicts that toxicity to
aquatic organisms may occur at
concentrations that exceed 60 ppb for
P–17–235 and 44 ppb for P–18–226. The
Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I),
based on a finding that in the absence
of sufficient information to permit a
reasoned evaluation, the substances may
present an unreasonable risk of injury to
human health or the environment. To
protect against these risks, the Order
requires:
• Use of the PMN substances only for
the uses allowed in the Order; and
• No release of the PMN substances
resulting in surface water
concentrations that exceed 44 ppb.
The proposed SNUR would designate
as a ‘‘significant new use’’ the absence
of these protective measures.
Potentially Useful Information: EPA
has determined that certain information
may be potentially useful in support of
a request by the PMN submitter to
modify the Order, or if a manufacturer
or processor is considering submitting a
SNUN for a significant new use that will
be designated by this SNUR. EPA has
determined that the results of chronic
aquatic toxicity, reproductive toxicity,
and pulmonary effects testing may be
potentially useful to characterize the
human health and environmental effects
of the PMN substances. Although the
Order does not require these tests, the
Order’s restrictions remain in effect
until the Order is modified or revoked
by EPA based on submission of this or
other relevant information.
CFR Citations: 40 CFR 721.11575 (P–
17–235) and 40 CFR 721.11576 (P–18–
226).
PMN Number: P–17–259
Chemical Name: Halogenated
aromatic amine (generic).
CAS Number: Not available.
Effective Date of TSCA Order: August
31, 2020.
Basis for TSCA Order: The PMN states
that the generic (non-confidential) use
of the substance will be as a curative for
thermosetting resins. Based on
comparison to structurally analogous
chemical substances, EPA has identified
concerns for skin sensitization and
systemic effects (liver, blood, and
spleen). Based on comparison to
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analogous anilines, EPA predicts that
toxicity to aquatic organisms may occur
at concentrations that exceed 1 ppb. The
Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I),
based on a finding that in the absence
of sufficient information to permit a
reasoned evaluation, the substance may
present an unreasonable risk of injury to
human health or the environment. To
protect against these risks, the Order
requires:
• No release of the PMN substance
resulting in surface water
concentrations that exceed 1 ppb.
The proposed SNUR would designate
as a ‘‘significant new use’’ the absence
of these protective measures.
Potentially Useful Information: EPA
has determined that certain information
may be potentially useful in support of
a request by the PMN submitter to
modify the Order, or if a manufacturer
or processor is considering submitting a
SNUN for a significant new use that will
be designated by this SNUR. EPA has
determined that the results of skin
sensitization, specific target organ
toxicity, and aquatic toxicity testing
may be potentially useful to characterize
the human health and environmental
effects of the PMN substance. Although
the Order does not require these tests,
the Order’s restrictions remain in effect
until the Order is modified or revoked
by EPA based on submission of this or
other relevant information.
CFR Citation: 40 CFR 721.11577.
PMN Number: P–18–43
Chemical Name: 1,4Benzenedicarboxylic acid, 1,4-dipentyl
ester, branched and linear.
CAS Number: 2097734–13–7.
Effective Date of TSCA Order:
September 16, 2020.
Basis for TSCA Order: The PMN states
that the use will be as a plasticizer or
fast fuser in PVC-plastisols for flooring,
wall paper, coated fabrics, underbody
coating; processing aid or fast fuser in
PVC dry blends for flooring, coated
fabrics, films & sheets, tubes & hoses;
flexibilizing additive for paints and
lacquers; use in formulation or repacking; and as a laboratory agent.
Based on the potential metabolite
terephthalic acid, EPA has identified
concerns for systemic toxicity. Based on
comparison to analogous esters, EPA
predicts that toxicity to aquatic
organisms may occur at concentrations
that exceed 2 ppb. The Order was issued
under TSCA sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)(I), based on a finding that
in the absence of sufficient information
to permit a reasoned evaluation, the
substance may present an unreasonable
risk of injury to human health or the
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environment. The Order was also issued
under TSCA sections 5(a)(3)(B)(ii)(II)
and 5(e)(1)(A)(ii)(II), based on a finding
that the substance is expected to be
produced in substantial quantities, and
that there may be a significant or
substantial human exposure to the
substance, and that the substance may
enter the environment in substantial
quantities. To protect against these
risks, the Order requires:
• No release of the PMN substance
resulting in surface water
concentrations that exceed 2 ppb.
The proposed SNUR would designate
as a ‘‘significant new use’’ the absence
of these protective measures.
Potentially Useful Information: EPA
has determined that certain information
may be potentially useful in support of
a request by the PMN submitter to
modify the Order, or if a manufacturer
or processor is considering submitting a
SNUN for a significant new use that will
be designated by this SNUR. EPA has
determined that the results of chronic
aquatic toxicity testing may be
potentially useful to characterize the
environmental effects of the PMN
substance. Although the Order does not
require these tests, the Order’s
restrictions remain in effect until the
Order is modified or revoked by EPA
based on submission of this or other
relevant information.
CFR Citation: 40 CFR 721.11578.
PMN Numbers: P–18–178, P–18–217,
and P–18–218
Chemical Names: Dialkyltin
dialkylcarboxylate (generic) (P–18–178),
Alkyltin dodecylthioester (generic) (P–
18–217), and Alkyltin
tetradecylthioester (generic) (P–18–218).
CAS Numbers: Not available.
Effective Date of TSCA Order: May 20,
2020.
Basis for TSCA Order: The PMNs state
that the use of the substances will be as
stabilizers for PVC compounds. 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 at 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 comparison to analogous chemical
substances, EPA has identified concerns
for immune, reproductive,
developmental, and systemic effects.
Based on comparison to analogous
organotins, EPA predicts that toxicity to
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aquatic organisms may occur at
concentrations that exceed 2 ppb. The
Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I),
based on a finding that in the absence
of sufficient information to permit a
reasoned evaluation, the substances may
present an unreasonable risk of injury to
human health or the environment. The
Order was also issued under TSCA
sections 5(a)(3)(B)(ii)(II) and
5(e)(1)(A)(ii)(II), based on a finding that
the substances are or will be produced
in substantial quantities and that the
substances either enter or may
reasonably be anticipated to enter the
environment in substantial quantities,
or there is or may be a significant (or
substantial) human exposure to the
substances. To protect against these
risks, the Order requires:
• Use of personal protective
equipment where there is a potential for
dermal exposure;
• Use of a NIOSH-certified respirator
with an APF of at least 10 where there
is a potential for inhalation exposure for
P–18–178;
• No use of the PMN substances other
than as stabilizers for PVC compounds;
and
• No release of the PMN substances
into the waters of the United States.
The proposed SNUR would designate
as a ‘‘significant new use’’ the absence
of these protective measures.
Potentially Useful Information: EPA
has determined that certain information
may be potentially useful in support of
a request by the PMN submitter to
modify the Order, or if a manufacturer
or processor is considering submitting a
SNUN for a significant new use that will
be designated by this SNUR. EPA has
determined that the results of
persistence, bioaccumulation, aquatic
toxicity, reproductive toxicity and
specific target organ toxicity testing may
be potentially useful to characterize the
human health and environmental effects
of the PMN substances. Although the
Order does not require these tests, the
Order’s restrictions remain in effect
until the Order is modified or revoked
by EPA based on submission of this or
other relevant information.
CFR Citations: 40 CFR 721.11579 (P–
18–178), 40 CFR 721.11580 (P–18–217),
and 40 CFR 721.11581 (P–18–218).
PMN Number: P–18–256
Chemical Name: Undecanol,
branched.
CAS Number: 203473–00–4.
Effective Date of TSCA Order: August
18, 2020.
Basis for TSCA Order: The PMN states
that the generic (non-confidential) use
will be as a chemical intermediate and
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a solvent. Based on submitted test data
on the new chemical substance, EPA
has identified concerns for skin and eye
irritation and systemic toxicity. Based
on test data for structurally analogous
chemical substance, EPA has also
identified concerns for developmental
and systemic toxicity. Based on
comparison to analogous neutral
organics, EPA predicts that toxicity to
aquatic organisms may occur at
concentrations that exceed 4 ppb. The
Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I),
based on a finding that in the absence
of sufficient information to permit a
reasoned evaluation, the substance may
present an unreasonable risk of injury to
human health or the environment. The
Order was also issued under TSCA
sections 5(a)(3)(B)(ii)(II) and
5(e)(1)(A)(ii)(II), based on a finding that
the substance is expected to be
produced in substantial quantities, and
that there may be significant or
substantial human exposure to the
substance, and that the substance may
enter the environment in substantial
quantities. To protect against these
risks, the Order requires:
• No use of the PMN substance other
than as a chemical intermediate; and
• No release of the PMN substance
resulting in surface water
concentrations that exceed 4 ppb.
The proposed SNUR would designate
as a ‘‘significant new use’’ the absence
of these protective measures.
Potentially Useful Information: EPA
has determined that certain information
may be potentially useful in support of
a request by the PMN submitter to
modify the Order, or if a manufacturer
or processor is considering submitting a
SNUN for a significant new use that will
be designated by this SNUR. EPA has
determined that the results of specific
organ toxicity, developmental toxicity,
and aquatic toxicity testing may be
potentially useful to characterize the
human health and environmental effects
of the PMN substance. Although the
Order does not require these tests, the
Order’s restrictions remain in effect
until the Order is modified or revoked
by EPA based on submission of this or
other relevant information.
CFR Citation: 40 CFR 721.11582.
Basis for TSCA Order: The PMN states
that the generic (non-confidential) use
of the substance will be for open, nondispersive use. Based on comparison to
structurally analogous chemical
substances for the low molecular weight
(LMW) fractions of the PMN substance,
EPA has identified concerns for
irritation and sensitization. Based on
comparison to structurally analogous
chemical substances, EPA has also
identified concerns for reproductive
toxicity and systemic effects. Based on
comparison to analogous aliphatic
amines and polycationic polymers, EPA
predicts toxicity to aquatic organisms
may occur at concentrations that exceed
4 ppb. The Order was issued under
TSCA sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)(I), based on a finding that
in the absence of sufficient information
to permit a reasoned evaluation, the
substance may present an unreasonable
risk of injury to human health and the
environment. To protect against these
risks, the Order requires:
• Use of personal protective
equipment where there is a potential for
dermal exposure;
• Establishment of a hazard
communication program, including
human health precautionary statements
on each label and in the SDS; and
• No release of the PMN substance
into the waters of the United States.
The proposed SNUR would designate
as a ‘‘significant new use’’ the absence
of these protective measures.
Potentially Useful Information: EPA
has determined that certain information
may be potentially useful in support of
a request by the PMN submitter to
modify the Order, or if a manufacturer
or processor is considering submitting a
SNUN for a significant new use that will
be designated by this SNUR. EPA has
determined that the results of aquatic
toxicity, skin and eye irritation, skin
sensitization, reproductive toxicity, and
specific target organ toxicity testing may
be potentially useful to characterize the
human health and environmental effects
of the PMN substance. Although the
Order does not require these tests, the
Order’s restrictions remain in effect
until the Order is modified or revoked
by EPA based on a submission of this
or other relevant information.
CFR Citation: 40 CFR 721.11583.
PMN Number: P–18–283
PMN Number: P–18–298
Chemical Name: 1,3-Propanediol, 2ethyl-2-(hydroxymethyl)-, polymer with
ethyleneamine, 2(chloromethyl)oxirane, 2-[[4-(1,1dimethylethyl)phenoxy]methyl]oxirane,
2,2′-[1,6-hexanediylbis(oxymethylene)]
bis[oxirane], 4,4′-(1-methylethylidene)
bis[phenol], alkyl ether amine, and 2-
Chemical Name: Hydroxy alkanoic
acid, compds. with
aminoalkoxyalcohol-epoxy polymeralkanolamine reaction products
(generic).
CAS Number: Not available.
Effective Date of TSCA Order: March
31, 2020.
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[(2-methylphenoxymethyl]oxirane
(generic).
CAS Number: Not available.
Effective Date of TSCA Order: August
4, 2020.
Basis for TSCA Order: The PMN states
that the generic (non-confidential) use
will be as an epoxy curing agent. Based
on comparison to structurally analogous
amines and the LMW fractions, EPA has
identified concerns for skin and eye
irritation, dermal and respiratory
sensitization, and lung effects. Based on
the comparison to structurally
analogous epoxide residuals, EPA has
also identified concerns for
reproductive toxicity and systemic
effects. Based on comparison to
analogous aliphatic amines and
polycationic polymers, EPA predicts
toxicity to aquatic organisms may occur
at concentrations that exceed 50 ppb.
The Order was issued under TSCA
sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)(I), based on a finding that
in the absence of sufficient information
to permit a reasoned evaluation, the
substance may present an unreasonable
risk of injury to human health or the
environment. To protect against these
risks, the Order requires:
• No manufacturing, processing, or
use of the PMN substance in an
application method that results in
inhalation exposure;
• No use of the PMN substance in a
consumer product; and
• No release of the PMN substance
resulting in surface water
concentrations that exceed 50 ppb.
The proposed SNUR would designate
as a ‘‘significant new use’’ the absence
of these protective measures.
Potentially Useful Information: EPA
has determined that certain information
may be potentially useful in support of
a request by the PMN submitter to
modify the Order, or if a manufacturer
or processor is considering submitting a
SNUN for a significant new use that will
be designated by this SNUR. EPA has
determined that the results of
absorption, eye damage, skin irritation,
specific target organ toxicity, and
aquatic toxicity testing may be
potentially useful to characterize the
human health and environmental effects
of the PMN substance. Although the
Order does not require these tests, the
Order’s restrictions remain in effect
until the Order is modified or revoked
by EPA based on submission of this or
other relevant information.
CFR Citation: 40 CFR 721.11584.
PMN Number: P–18–310
Chemical Name: Benzenepropanoic
acid, 3-(2H-benzotriazol-2-yl)-5-(1,1-
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dimethylethyl)-4-hydroxy-2,2bis(hydroxymethyl)butyl ester.
CAS Number: 2101609–93–0.
Effective Date of TSCA Order: August
14, 2020.
Basis for TSCA Order: The PMN states
that the generic (non-confidential) use
will be as a polymer additive. Based on
test data on structurally analogous
chemical substances, EPA has identified
concerns for blood, liver, thyroid and
kidney effects, reproductive toxicity,
and developmental toxicity. Based on
comparison to analogous phenols and
benzotriazoles, EPA predicts toxicity to
aquatic organisms may occur at
concentrations that exceed 1 ppb. The
Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I),
based on a finding that in the absence
of sufficient information to permit a
reasoned evaluation, the substance may
present an unreasonable risk of injury to
human health or the environment. To
protect against these risks, the Order
requires:
• Use of personal protective
equipment where there is a potential for
dermal exposure;
• Use of a NIOSH-certified respirator
with an APF of at least 1,000 where
there is a potential for inhalation
exposure;
• Establishment of a hazard
communication program, including
human health precautionary statements
on each label and in the SDS; and
• No release of the PMN substance
resulting in surface water
concentrations that exceed 1 ppb.
The proposed SNUR would designate
as a ‘‘significant new use’’ the absence
of these protective measures.
Potentially Useful Information: EPA
has determined that certain information
may be potentially useful in support of
a request by the PMN submitter to
modify the Order, or if the manufacturer
or processor is considering submitting a
SNUN for a significant new use that will
be designated by this SNUR. EPA has
determined that the results of
developmental neurotoxicity and
aquatic toxicity testing may be
potentially useful to characterize the
human health and environmental effects
of the PMN substance. Although the
Order does not require these tests, the
Order’s restrictions remain in effect
until the Order is modified or revoked
by EPA based on submission of this or
other relevant information.
CFR Citation: 40 CFR 721.11585.
PMN Number: P–18–318
Chemical Name: 1Octadecanaminium, N,N-dimethyl-N[3-(triethoxysilyl)propyl]-, chloride
(1:1).
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CAS Number: 62117–57–1.
Effective Date of TSCA Order:
September 25, 2020.
Basis for TSCA Order: The PMN states
that the use will be as a surface
treatment for added lubricity and antistatic purposes. Based on comparison to
structurally analogous chemical
substances, EPA has identified concerns
for irritation to the eyes, skin, and
respiratory tract and liver effects. Based
on comparison to structurally analogous
chemical substances and structural
alerts for cationic surfactants, EPA has
also identified concerns for lung effects.
Based on comparison to analogous
polycationic polymers, EPA predicts
toxicity to aquatic organisms may occur
at concentrations that exceed 1 ppb. The
Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I),
based on a finding that in the absence
of sufficient information to permit a
reasoned evaluation, the substance may
present an unreasonable risk of injury to
human health or the environment. To
protect against these risks, the Order
requires:
• Establishment of a hazard
communication program, including
human health precautionary statements
on each label and in the SDS;
• Use of the PMN substance only as
a surface treatment for added lubricity
and anti-static properties;
• No use of the PMN substance in an
application method that results in
inhalation exposure; and
• No release of the PMN substance
resulting in surface water
concentrations that exceed 1 ppb.
The proposed SNUR would designate
as a ‘‘significant new use’’ the absence
of these protective measures.
Potentially Useful Information: EPA
has determined that certain information
may be potentially useful in support of
a request by the PMN submitter to
modify the Order, or if a manufacturer
or processor is considering submitting a
SNUN for a significant new use that will
be designated by this SNUR. EPA has
determined that the results of skin
irritation, eye irritation, pulmonary
effects, and aquatic toxicity testing may
be potentially useful to characterize the
human health and environmental effects
of the PMN substance. Although the
Order does not require these tests, the
Order’s restrictions remain in effect
until the Order is modified or revoked
by EPA based on submission of this or
other relevant information.
CFR Citation: 40 CFR 721.11586.
PMN Number: P–18–323
Chemical Name: 2-Propenoic acid, 2methyl-, 3-methyl-3-buten-1-yl ester.
CAS Number: 156291–88–2.
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Effective Date of TSCA Order: March
13, 2020.
Basis for TSCA Order: The PMN states
that the generic (non-confidential) use
of the PMN substance will be as a raw
material for polymer manufacturing.
Based on submitted test data on the
PMN substance and structural alerts,
EPA has identified concerns for skin
irritation and skin/respiratory
sensitization. Based on comparison to
structurally analogous chemical
substances, EPA has also identified
concerns for systemic, respiratory, and
developmental effects. Based on
comparison to analogous methacrylates,
EPA predicts toxicity to aquatic
organisms may occur at concentrations
that exceed 98 ppb. The Order was
issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I),
based on a finding that in the absence
of sufficient information to permit a
reasoned evaluation, the substance may
present an unreasonable risk of injury to
human health or the environment. To
protect against these risks, the Order
requires:
• Use of personal protective
equipment where there is a potential for
dermal exposure;
• Use of a NIOSH-certified respirator
with an APF of at least 50 to prevent
inhalation exposure where there is a
potential for inhalation exposure;
• Establishment of a hazard
communication program, including
human health precautionary statements
on each label and in the SDS;
• Use of the PMN substance only for
the confidential use allowed in the
Order; and
• No release of the PMN substance
resulting in surface water
concentrations that exceed 98 ppb.
The proposed SNUR designates as a
‘‘significant new use’’ the absence of
these protective measures.
Potentially Useful Information: EPA
has determined that certain information
may be potentially useful in support of
a request by the PMN submitter to
modify the Order, or if a manufacturer
or processor is considering submitting a
SNUN for a significant new use that
would be designated by this SNUR. EPA
has determined that the results of
chronic aquatic toxicity and specific
target organ toxicity testing may be
potentially useful to characterize the
environmental and human health effects
of the PMN substance. Although the
Order does not require these tests, the
Order’s restrictions remain in effect
until the Order is modified or revoked
by EPA based on submission of this or
other relevant information.
CFR Citation: 40 CFR 721.11587.
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PMN Number: P–18–327
Chemical Name: Mixed metal oxide
(generic).
CAS Number: Not available.
Effective Date of TSCA Order: August
21, 2020.
Basis for TSCA Order: The PMN states
that the generic (non-confidential) use
will be as a filler for non-dispersive
resins. Based on comparison to
structurally analogous chemical
substances, EPA has identified concerns
for dermal and respiratory sensitization.
EPA has also identified concerns for
lung effects (lung overload) if the
particulate is respirable, based on
information for other poorly soluble
particulates, and carcinogenicity if the
PMN substance is crystalline and
respirable. The Order was issued under
TSCA sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)(I), based on a finding that
in the absence of sufficient information
to permit a reasoned evaluation, the
substance may present an unreasonable
risk of injury to human health or the
environment. To protect against these
risks, the Order requires:
• Use of personal protective
equipment where there is a potential for
dermal exposure;
• Use of a NIOSH-certified respirator
with an APF of at least 1,000 where
there is a potential for inhalation
exposure, or compliance with a NCEL of
0.1 mg/m3 as an 8-hour time-weighted
average (TWA) to prevent inhalation
exposure; and
• Establishment of a hazard
communication program, including
human health precautionary statements
on each label and in the SDS.
The proposed SNUR would designate
as a ‘‘significant new use’’ the absence
of these protective measures.
Potentially Useful Information: EPA
has determined that certain information
may be potentially useful in support of
a request by the PMN submitter to
modify the Order, or if a manufacturer
or processor is considering submitting a
SNUN for a significant new use that will
be designated by this SNUR. EPA has
determined that the results of
pulmonary toxicity, skin sensitization,
and carcinogenicity testing may be
potentially useful to characterize the
human health effects of the PMN
substance. Although the Order does not
require these tests, the Order’s
restrictions remain in effect until the
Order is modified or revoked by EPA
based on submission of this or other
relevant information.
CFR Citation: 40 CFR 721.11588.
fraction, polymers with guanidine
hydrochloride (1:1).
CAS Number: 1902936–67–7.
Effective Date of TSCA Order: March
17, 2020.
Basis for TSCA Order: The PMN states
that the use of the substance will be as
an aldehyde scavenger for the
manufacture of polyurethane foams.
Based on comparison to structurally
analogous chemical substances, EPA has
identified concerns for skin
sensitization. Based on available test
data on the PMN substance, EPA has
also identified concerns for acute
toxicity. Based on structural alerts for
polycationic binding, EPA has also
identified concerns for lung effects.
Based on comparison to structurally
analogous polycationic polymers, EPA
predicts that toxicity to aquatic
organisms may occur at concentrations
that exceed 2 ppb. The Order was issued
under TSCA sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)(I), based on a finding that
in the absence of sufficient information
to permit a reasoned evaluation, the
substance may present an unreasonable
risk of injury to human health and the
environment. To protect against these
risks, the Order requires:
• Use of personal protective
equipment where there is a potential for
dermal exposure;
• Establishment of a hazard
communication program, including
human health precautionary statements
on each label and in the SDS; and
• No release of the PMN substance
resulting in surface water
concentrations that exceed 2 ppb.
The proposed SNUR would designate
as a ‘‘significant new use’’ the absence
of these protective measures.
Potentially Useful Information: EPA
has determined that certain information
about may be potentially useful in
support of a request by the PMN
submitter to modify the Order, or if a
manufacturer or processor is
considering submitting a SNUN for a
significant new use that would be
designated by this SNUR. EPA has
determined that the results of aquatic
toxicity, pulmonary effects and skin
sensitization testing may be potentially
useful to characterize the human health
and environmental effects of the PMN
substance. Although the Order does not
require these tests, the Order’s
restrictions remain in effect until the
Order is modified or revoked by EPA
based on submission of this or other
relevant information.
CFR Citation: 40 CFR 721.11589.
PMN Number: P–18–347
Chemical Name: Amines,
polyethylenepoly-, triethylenetetramine
PMN Number: P–18–405
Chemical Name: Phenol, 4,4′-(1methylethylidene)bis-, polymer with
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3,6,9,12-tetraoxatetradeca-1, 13-diene,
glycidyl ether.
CAS Number: 647028–24–8.
Effective Date of TSCA Order: August
7, 2020.
Basis for TSCA Order: The PMN states
that the generic (non-confidential) use
will be as an adhesive. Based on the
epoxide moiety for the LMW fraction,
EPA has identified concerns for skin
and lung sensitization, carcinogenicity,
developmental toxicity, male
reproductive toxicity, liver, and kidney
toxicity. Based on submitted test data,
information in the SDS, and analogous
epoxides, EPA has also identified
concerns for skin irritation and
genotoxicity. Based on comparison to
analogous epoxides, EPA predicts
toxicity to aquatic organisms may occur
at concentrations that exceed 1 ppb. The
Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I),
based on a finding that in the absence
of sufficient information to permit a
reasoned evaluation, the substance may
present an unreasonable risk of injury to
human health or the environment. To
protect against such risks, the Order
requires:
• No manufacturing, processing, or
use of the PMN substance in a manner
that results in inhalation exposure;
• No use of the PMN substance in a
consumer product; and
• No release of the PMN substance
resulting in surface water
concentrations that exceed 1 ppb.
The proposed SNUR would designate
as a ‘‘significant new use’’ the absence
of these protective measures.
Potentially Useful Information: EPA
has determined that certain information
may be potentially useful in support of
a request by the PMN submitter to
modify the Order, or if a manufacturer
or processor is considering submitting a
SNUN for a significant new use that will
be designated by this SNUR. EPA has
determined that the results of
pulmonary toxicity, skin sensitization,
carcinogenicity, reproductive/
developmental toxicity, skin and eye
irritation, specific target organ toxicity
and aquatic toxicity testing may be
potentially useful to characterize the
human health and environmental effects
of the PMN substance. Although the
Order does not require these tests, the
Order’s restrictions remain in effect
until the Order is modified or revoked
by EPA based on submission of this or
other relevant information.
CFR Citation: 40 CFR 721.11590.
PMN Number: P–19–36
Chemical Name: 1,4Benzenedicarboxylic acid, 1,4-bis(2phenoxyethyl) ester.
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CAS Number: 25900–07–6.
Effective Date of TSCA Order: July 24,
2020.
Basis for TSCA Order: The PMN states
that the use will be as an additive to
polymers for improvement in gas barrier
performance. Based on comparison to
structurally analogous chemical
substances, EPA has identified concerns
for irritation to the skin, eyes, and
respiratory tract. Based on test data for
terephthalic acid, EPA has also
identified concerns for bladder effects
and developmental effects. Based on test
data for 2-phenoxyethanol, EPA has also
identified concerns for blood effects,
kidney effects, bladder effects, and
respiratory tract effects. Based on
comparison to analogous esters, EPA
predicts that toxicity to aquatic
organisms may occur at concentrations
that exceed 3 ppb. The Order was issued
under TSCA sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)(I), based on a finding that
in the absence of sufficient information
to permit a reasoned evaluation, the
substance may present an unreasonable
risk of injury to human health or the
environment. To protect against these
risks, the Order requires:
• Use of personal protective
equipment where there is a potential for
dermal exposure;
• Use of a NIOSH-certified respirator
with an APF of at least 1,000 where
there is a potential for inhalation
exposure; and
• No release of the PMN substance
resulting in surface water
concentrations that exceed 3 ppb.
The proposed SNUR would designate
as a ‘‘significant new use’’ the absence
of these protective measures.
Potentially Useful Information: EPA
has determined that certain information
may be potentially useful in support of
a request by the PMN submitter to
modify the Order, or if a manufacturer
or processor is considering submitting a
SNUN for a significant new use that will
be designated by this SNUR. EPA has
determined that the results of skin
irritation, reproductive/developmental
toxicity, specific target organ toxicity,
and aquatic toxicity testing may be
potentially useful to characterize the
human health and environmental effects
of the PMN substance. Although the
Order does not require these tests, the
Order’s restrictions remain in effect
until the Order is modified or revoked
by EPA based on submission of this or
other relevant information.
CFR Citation: 40 CFR 721.11591.
PMN Number: P–19–52
Chemical Name: Poly(oxy-1,2ethanediyl), .alpha.-nonyl-.omega.hydroxy-, branched and linear.
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CAS Number: 2242406–13–7.
Effective Date of TSCA Order:
February 14, 2020.
Basis for TSCA Order: The PMN states
that the use of the PMN substance will
be as a hard surface cleaner and as a
component of laundry detergent. Based
on repeating polyether units, EPA has
identified concerns for surfactant effects
on the lungs. Based on comparison to
structurally analogous chemical
substances, EPA has also identified
concerns for eye corrosion and mild
skin irritation. Based on alcohol
ethoxylates, EPA has also identified
liver, cardiac, and systemic effects.
Based on comparison to analogous
nonionic surfactants, EPA predicts
toxicity to aquatic organisms may occur
at concentrations that exceed 34 ppb.
The Order was issued under TSCA
sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)(I), based on a finding that
in the absence of sufficient information
to permit a reasoned evaluation, the
substance may present an unreasonable
risk of injury to human health or the
environment. To protect against these
risks, the Order requires:
• Use of personal protective
equipment where there is a potential for
dermal exposure;
• Use of a NIOSH-certified respirator
with an APF of at least 1,000 where
there is potential for inhalation
exposure;
• Establishment of a hazard
communication program, including
human health precautionary statements
on each label and in the SDS;
• No use of the PMN substance where
the concentration of the PMN substance
in the product formulation intended for
distribution in commerce exceeds 1%
by weight; and
• No release of the PMN substance
resulting in surface water
concentrations that exceed 34 ppb.
The proposed SNUR would designate
as a ‘‘significant new use’’ the absence
of these protective measures.
Potentially Useful Information: EPA
has determined that certain information
may be potentially useful in support of
a request by the PMN submitter to
modify the Order, or if a manufacturer
or processor is considering submitting a
SNUN for a significant new use that will
be designated by this SNUR. EPA has
determined that the results of acute
aquatic toxicity, chronic aquatic
toxicity, pulmonary effects, specific
target organ toxicity, eye damage, and
skin irritation testing may be potentially
useful to characterize the human health
and environmental effects of the PMN
substance. Although the Order does not
require these tests, the Order’s
restrictions still remain in effect until
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the Order is modified or revoked by
EPA based on submission of this or
other relevant information.
CFR Citation: 40 CFR 721.11592.
PMN Number: P–19–53
Chemical Name: 1-Butanamine, Nbutyl-N-[(triethoxysilyl)methyl]-.
CAS Number: 35501–23–6.
Effective Date of TSCA Order: August
5, 2020.
Basis for TSCA Order: The PMN states
that the use of the substance will be as
a surface treatment, sealant, caulk, and
coating for mineral building materials
such as concrete, brick, limestone, and
plaster, as well as on wood, metal, and
other substrates. Based on the
alkoxysilanes category and reactivity of
the new chemical substance, EPA has
identified concerns for lung effects.
Based on submitted test data, EPA has
also identified concerns for skin
sensitization and developmental effects.
Based on comparison to analogous
aliphatic amines, EPA predicts toxicity
to aquatic organisms may occur in
concentrations that exceed 150 ppb. The
Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I),
based on a finding that in the absence
of sufficient information to permit a
reasoned evaluation, the substance may
present an unreasonable risk of injury to
human health or the environment. To
protect against these risks, the Order
requires:
• Use of dermal protective equipment
where there is a potential for dermal
exposure;
• No import, processing, or use of the
PMN substance other than in liquid
form;
• No domestic manufacture (i.e.,
import only); and
• No use of the PMN substance in a
consumer product.
The proposed SNUR would designate
as a ‘‘significant new use’’ the absence
of these protective measures.
Potentially Useful Information: EPA
has determined that certain information
may be potentially useful in support of
a request by the PMN submitter to
modify the Order, or if a manufacturer
or processor is considering submitting a
SNUN for a significant new use that will
be designated by this SNUR. EPA has
determined that the results of
pulmonary effects and skin sensitization
testing may be potentially useful to
characterize the human health effects of
the PMN substance. Although the Order
does not require these tests, the Order’s
restrictions remain in effect until the
Order is modified or revoked by EPA
based on submission of this or other
relevant information.
CFR Citation: 40 CFR 721.11593.
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PMN Number: P–19–77
Chemical Name: Alkenylamide
(generic).
CAS Number: Not available.
Effective Date of TSCA Order: March
31, 2020.
Basis for TSCA Order: The PMN states
that the generic (non-confidential) use
of the substance will be for agricultural
use. Based on available test data on a
structurally analogous chemical
substance, EPA has identified concerns
for skin irritation, eye irritation,
reproductive toxicity, and systemic
toxicity. Based on information in the
SDS, EPA has also identified concerns
for respiratory tract irritation. Based on
comparison to analogous amides, EPA
predicts toxicity to aquatic organisms
may occur at concentrations that exceed
4 ppb. The Order was issued under
TSCA sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)I), based on a finding that in
the absence of sufficient information to
permit a reasoned evaluation, the
substance may present an unreasonable
risk of injury to human health and the
environment. To protect against these
risks, the Order requires:
• Use of the PMN substance only for
the confidential use allowed in the
Order; and
• No release of the PMN substance
resulting in surface water
concentrations that exceed 4 ppb.
The proposed SNUR would designate
as a ‘‘significant new use’’ the absence
of these protective measures.
Potentially Useful Information: EPA
has determined that certain information
may be potentially useful in support of
a request by the PMN submitter to
modify the Order, or if a manufacturer
or processor is considering submitting a
SNUN for a significant new use that
would be designated by this SNUR. EPA
has determined that the results of eye
damage, skin irritation, specific target
organ toxicity, and aquatic toxicity
testing may be potentially useful to
characterize the human health and
environmental effects of the PMN
substance. Although the Order does not
require these tests, the Order’s
restrictions remain in effect until the
Order is modified or revoked by EPA
based on submission of this or other
relevant information.
CFR Citation: 40 CFR 721.11594.
PMN Number: P–19–131
Chemical Name: Isoalkylaminium, Nisoalkyl, -N, N-dimethyl chloride
(generic).
CAS Number: Not available.
Effective Date of TSCA Order: July 24,
2020.
Basis for TSCA Order: The PMN states
that the generic (non-confidential) use
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will be as an additive for horizontal oil
drilling. Based on comparison to
structurally analogous chemical
substances, EPA has identified concerns
for irritation to the eyes and skin,
systemic effects, lung effects, and
developmental effects. Based on
comparison to analogous chemical
substances, EPA predicts toxicity to
aquatic organisms may occur at
concentrations that exceed 1 ppb. The
Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I),
based on a finding that in the absence
of sufficient information to permit a
reasoned evaluation, the substance may
present an unreasonable risk of injury to
human health or the environment. To
protect against these risks, the Order
requires:
• Establishment of a hazard
communication program, including
human health precautionary statements
on each label and in the SDS;
• No manufacturing, processing, or
use of the PMN substance in a manner
that results in inhalation exposure;
• No use of the PMN substance in
consumer products; and
• No release of the PMN substance
resulting in surface water
concentrations that exceed 1 ppb.
The proposed SNUR would designate
as a ‘‘significant new use’’ the absence
of these protective measures.
Potentially Useful Information: EPA
has determined that certain information
may be potentially useful in support of
a request by the PMN submitter to
modify the Order, or if a manufacturer
or processor is considering submitting a
SNUN for a significant new use that will
be designated by this SNUR. EPA has
determined that the results of skin
irritation, eye irritation, specific target
organ toxicity, and aquatic toxicity
testing may be potentially useful to
characterize the human health and
environmental effects of the PMN
substance. Although the Order does not
require these tests, the Order’s
restrictions remain in effect until the
Order is modified or revoked by EPA
based on submission of this or other
relevant information.
CFR Citation: 40 CFR 721.11595.
PMN Numbers: P–19–143 and P–19–144
Chemical Names: Aldehyde, polymer
with mixed alkane polyamines, 2,2′[1,4alkanediylbis(oxyalkylene)]bis[oxirane],
2-(alkoxyalkyloxirane, 4,4′-(1alkylidene)bis[phenol], 2,2′-[(1alkylidene)bis(4,1alkyleneoxyalkylene)]bis[oxirane] and
2-(aryloxyalkyl)oxirane, acetate (salt)
(generic) (P–19–143) and Alkanedioic
acid, compds. with substituted
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arylalkylamine-arylalcohol
disubstituted alkane-the diglycidyl ether
of a arylalcohol disubstituted alkaneepichlorohydrin-aldehyde-2,2′[(1alkylidene)bis[4,1-aryleneoxy(alkyl-2,1alkanediyl)oxyalkylene]]bis[oxirane]alkanepolyamine polymer-1-[[2-[(2aminoalkyl)amino]alkyl]amino]-3aryloxy-2-alcohol reaction products
(generic) (P–19–144).
CAS Numbers: Not available.
Effective Date of TSCA Order:
February 18, 2020.
Basis for TSCA Order: The PMNs state
that the use of the substances will be as
a crosslinking agent for use in epoxy
resin for water-based coating for a
variety of substrates and civil
applications in commercial uses (P–19–
143) and a crosslinking agent in epoxy
based self-leveling floor coatings (P–19–
144). EPA has identified concerns for
lung effects (cationic binding) if
respirable particles are inhaled. Based
on structural alerts for polyamines, EPA
has identified dermal and respiratory
sensitization. Based on comparison to
analogous chemical substances, EPA has
identified concerns for skin and eye
irritation. Based on the LMW species,
EPA has also identified concerns for
systemic, reproductive, and
developmental effects. Based on
comparison to analogous polycationic
polymers, EPA predicts toxicity to
aquatic organisms may occur at
concentrations that exceed 1 ppb. The
Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I),
based on a finding that in the absence
of sufficient information to permit a
reasoned evaluation, the substances may
present an unreasonable risk of injury to
human health or the environment. The
Order was also issued under TSCA
sections 5(a)(3)(B)(ii)(II) and
5(e)(1)(A)(ii)(II), based on a finding that
the substance which was the subject of
PMN P–19–143 is expected to be
produced in substantial quantities, and
that there may be significant or
substantial human exposure to the
substance, and that the substance may
enter the environment in substantial
quantities. To protect against these
risks, the Order requires:
• No manufacture, processing, or use
of the PMN substances in a manner that
results in inhalation exposure to either
the PMN substances or to formaldehyde;
• No use of the PMN substances in
consumer products; and
• No release of the PMN substances
resulting in surface water
concentrations that exceed 1 ppb.
The proposed SNUR would designate
as a ‘‘significant new use’’ the absence
of these protective measures.
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Potentially Useful Information: EPA
has determined that certain information
may be potentially useful in support of
a request by the PMN submitter to
modify the Order, or if a manufacturer
or processor is considering submitting a
SNUN for a significant new use that will
be designated by this SNUR. EPA has
determined that the results of
pulmonary effects, eye irritation, skin
irritation, skin sensitization, specific
target organ toxicity, reproductive and
developmental toxicity, and aquatic
toxicity testing may be potentially
useful to characterize the human health
and environmental effects of the PMN
substances. Although the Order does not
require these tests, the Order’s
restrictions remain in effect until the
Order is modified or revoked by EPA
based on submission of this or other
relevant information.
CFR Citations: 40 CFR 721.11596 (P–
19–143) and 40 CFR 721.11597 (P–19–
144).
PMN Number: P–19–145
Chemical Name: Polyazaalkane with
oxirane and methyloxirane, haloalkane
(generic).
CAS Number: Not available.
Effective Date of TSCA Order: July 6,
2020.
Basis for TSCA Order: The PMN states
that the use of the substance will be as
an oil field drilling fluid additive. Based
on structure, EPA has identified
concerns for lung effects (surfactancy).
Based on comparison to structurally
analogous chemical substances, EPA has
also identified concerns for
neurological, systemic, and
reproductive/developmental effects.
Based on comparison to analogous
cationic polymers, EPA predicts toxicity
to aquatic organisms may occur at
concentrations that exceed 26 ppb. The
Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I),
based on a finding that in the absence
of sufficient information to permit a
reasoned evaluation, the substance may
present an unreasonable risk of injury to
human health or the environment. To
protect against these risks, the Order
requires:
• Establishment of a hazard
communication program, including
human health precautionary statements
on each label and in the SDS;
• No manufacture, processing, or use
of the PMN substance in a manner that
results in inhalation exposure; and
• No release of the PMN substance
resulting in surface water
concentrations that exceed 26 ppb.
The proposed SNUR would designate
as a ‘‘significant new use’’ the absence
of these protective measures.
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Potentially Useful Information: EPA
has determined that certain information
may be potentially useful in support of
a request by the PMN submitter to
modify the Order, or if a manufacturer
or processor is considering submitting a
SNUN for a significant new use that will
be designated by this SNUR. EPA has
determined that the results of
neurotoxicity, specific target organ
toxicity, pulmonary effects,
reproductive/developmental effects, and
aquatic toxicity testing may be
potentially useful to characterize the
health and environmental effects of the
PMN substance. Although the Order
does not require these tests, the Order’s
restrictions remain in effect until the
Order is modified or revoked by EPA
based on submission of this or other
relevant information.
CFR Citation: 40 CFR 721.11598.
PMN Number: P–19–153
Chemical Name: Dibromoalkyl ether
tetrabromobisphenol A (generic).
CAS Number: None available.
Effective Date of TSCA Order: July 20,
2020.
Basis for TSCA Order: The PMN states
that the use of the substance will be as
a raw material in flame retardant
products. Based on the physical/
chemical properties of the PMN
substance and of the photolysis product,
the PMN substance and the photolysis
product are potentially persistent,
bioaccumulative, and toxic (PBT)
chemicals (as described in the New
Chemical Program’s PBT category at 64
FR 60194; November 4, 1999; FRL–
6097–7). EPA estimates that the PMN
substance will persist in the
environment for more than 6 months
and estimates a bioaccumulation factor
of greater than or equal to 1,000. EPA
estimates that the photolysis product
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 available
data on the PMN substance, EPA has
identified concerns for eye irritation,
systemic effects, and reproductive/
developmental effects. Based on data for
the photolysis product, EPA has also
identified concerns for systemic effects
and carcinogenicity. Based on
comparison to analogous anionic
surfactants, EPA predicts toxicity to
aquatic organisms may occur at
concentrations that exceed 1 ppb. The
Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I),
based on a finding that in the absence
of sufficient information to permit a
reasoned evaluation, the substance may
present an unreasonable risk of injury to
human health or the environment. To
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protect against these risks, the Order
requires:
• Use of personal protective
equipment where there is a potential for
dermal exposure;
• Establishment of a hazard
communication program, including
human health precautionary statements
on each label and in the SDS; and
• No release of the PMN substance
into surface waters of the United States.
The proposed SNUR would designate
as a ‘‘significant new use’’ in the
absence of these protective measures.
Potentially Useful Information: EPA
has determined that certain information
may be potentially useful in support of
a request by the PMN submitter to
modify the Order, or if a manufacturer
or processor is considering submitting a
SNUN for a significant new use that will
be designated by this SNUR. EPA has
determined that the results of
environmental fate, bioaccumulation,
specific target organ toxicity and
carcinogenicity testing may be
potentially useful to characterize the
human health effects of the PMN
substance. Although the Order does not
require these tests, the Order’s
restrictions remain in effect until the
Order is modified or revoked by EPA
based on submission of this or other
relevant information.
CFR Citation: 40 CFR 721.11599.
PMN Number: P–20–29
Chemical Name: Octonal, 7(or 8)formyl-.
CAS Number: 1607842–40–9.
Effective Date of TSCA Order: August
5, 2020.
Basis for TSCA Order: The PMN states
that the generic (non-confidential) use
will be as an oil soluble additive. Based
on submitted test data on the new
chemical substance, EPA has identified
concerns for skin and eye irritation,
dermal sensitization, systemic toxicity,
and neurotoxicity. Based on OECD
Toolbox results, EPA has identified
concerns for respiratory sensitization.
Based on comparison to structurally
analogous chemical substances, EPA has
also identified concerns for respiratory
effects. Based on comparison to
analogous neutral organics, EPA
predicts toxicity to aquatic organisms
may occur at concentrations that exceed
17 ppb. The Order was issued under
TSCA sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)(I), based on a finding that
in the absence of sufficient information
to permit a reasoned evaluation, the
substance may present an unreasonable
risk of injury to human health or the
environment. To protect against these
risks, the Order requires:
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• No release of the PMN substance
resulting in surface water
concentrations that exceed 17 ppb.
The proposed SNUR would designate
as a ‘‘significant new use’’ the absence
of these protective measures.
Potentially Useful Information: EPA
has determined that certain information
may be potentially useful in support of
a request by the PMN submitter to
modify the Order, or if a manufacturer
or processor is considering submitting a
SNUN for a significant new use that will
be designated by this SNUR. EPA has
determined that the results of aquatic
toxicity testing may be potentially
useful to characterize the environmental
effects of the PMN substance. Although
the Order does not require these tests,
the Order’s restrictions remain in effect
until the Order is modified or revoked
by EPA based on submission of this or
other relevant information.
CFR Citation: 40 CFR 721.115600.
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PMN Number: P–20–42
Chemical Name: Sulfonium, trisaryl-,
7,7-dialkyl-2-heteropolycyclic-1alkanesulfonate (1:1) (generic).
CAS Number: Not available.
Effective Date of TSCA Order: April
29, 2020.
Basis for TSCA Order: The PMN states
that the generic (non-confidential) use
of the PMN substance will be as a
photoacid generator. 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 at 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 the photoreactivity of the PMN
substance, EPA has identified concerns
for photosensitization. Based on
comparison to analogous substances,
EPA has identified concerns for eye
corrosion, irritation, acute toxicity, liver
toxicity, neurotoxicity, and reproductive
(developmental) toxicity. EPA has also
identified concerns for lung overload by
insoluble polymers for photoacid
generators with polymeric anions that
have a molecular weight over 10,000 g/
mol. The Order was issued under TSCA
sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)(I), based on a finding that
in the absence of sufficient information
to permit a reasoned evaluation, the
substance may present an unreasonable
risk of injury to human health or the
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environment. To protect against these
risks, the Order requires:
• No manufacture of the PMN
substance beyond the time limits
specified in the Order without submittal
to EPA the results of certain testing
described in the Testing section of the
Order.
• Use of personal protective
equipment where there is a potential for
dermal exposure;
• Establishment of a hazard
communication program, including
human health precautionary statements
on each label and in the SDS;
• No modification of the processing
of the PMN substance in any way that
generates a vapor, dust, mist, or aerosol
in a non-enclosed process;
• Use of the PMN substance only as
described in the PMN;
• No domestic manufacture of the
PMN substance (i.e., import only);
• Import of the PMN substance only
in solution, or in any form in sealed
containers weighing 5 kilograms or less;
and
• No exceedance of the confidential
annual importation volume listed the
Order.
The proposed SNUR would designate
as a ‘‘significant new use’’ the absence
of these protective measures.
Potentially Useful Information: EPA
has determined that certain information
about the physical/chemical properties,
fate, bioaccumulation, environmental
hazard, and human health effects of the
PMN substance may be potentially
useful in support of a request by the
PMN submitter to modify the Order, or
if a manufacturer or processor is
considering submitting a SNUN for a
significant new use that will be
designated by this SNUR. The submitter
has agreed not to exceed the time limits
specified in the Order without
performing the required Tier I and Tier
II testing outlined in the Testing section
of the Order.
CFR Citation: 40 CFR 721.11601.
PMN Number: P–20–104
Chemical Name: Alkenoic acid,
polymer with (alkyl alkenyl) polyether
(generic).
CAS Number: None available.
Effective Date of TSCA Order: August
25, 2020.
Basis for TSCA Order: The PMN states
that the generic (non-confidential) use
will be as an additive. Based on
structural alerts and comparison to
structurally analogous chemical
substances, EPA has identified concerns
for lung effects (surfactancy) and
irritation to the skin, eyes, and
respiratory tract. Based on comparison
to structurally analogous chemical
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substances, EPA has also identified
concerns for systemic effects (i.e.,
neurotoxicity and cardiotoxicity) and
aquatic toxicity. Based on a residual
which is present in the substance, EPA
has also identified concerns for
irritation/corrosion to the skin and eyes,
skin sensitization, systemic effects, and
developmental effects. The Order was
issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I),
based on a finding that in the absence
of sufficient information to permit a
reasoned evaluation, the substance may
present an unreasonable risk of injury to
human health. The Order was also
issued under TSCA sections
5(a)(3)(B)(ii)(II) and 5(e)(1)(A)(ii)(II),
based on a finding that the substance is
expected to be produced in substantial
quantities, and that there may be
significant or substantial human
exposure to the substance, and that the
substance may enter the environment in
substantial quantities. To protect against
these risks, the Order requires:
• No manufacture, processing, or use
of the PMN substance in a manner that
results in inhalation exposure;
• No use of the PMN substance in a
consumer product;
• No release of the PMN substance
resulting in surface water
concentrations that exceed 75 ppb.
The proposed SNUR would designate
as a ‘‘significant new use’’ the absence
of these protective measures.
Potentially Useful Information: EPA
has determined that certain information
may be potentially useful in support of
a request by the PMN submitter to
modify the Order, or if a manufacturer
or processor is considering submitting a
SNUN for a significant new use that will
be designated by this SNUR. EPA has
determined that the results of aquatic
toxicity testing may be potentially
useful to characterize the environmental
effects of the PMN substance. Although
the Order does not require these tests,
the Order’s restrictions remain in effect
until the Order is modified or revoked
by EPA based on submission of this or
other relevant information.
CFR Citation: 40 CFR 721.11602.
MCAN Number: J–16–26
Microorganism name: Trichoderma
reesei modified (generic).
CAS number: Not applicable.
Effective Date of TSCA Order: April
10, 2017.
Basis for TSCA Order: The MCAN
states that the generic (non-confidential)
use of the microorganism will be for
enzyme production. EPA determined
that certain fermentation conditions,
other than the typical submerged
standard industrial fermentation process
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for enzyme production, could result in
increased exposures. Specifically, EPA
is concerned that where growth on plant
material or on solid substrates occurs, T.
reesei has been shown to produce a
secondary metabolite known as
paracelsin, which is associated with a
variety of toxic effects to mammalian
and bacterial cells. 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 microorganism
may present an unreasonable risk of
injury to human health or the
environment. To protect against these
risks, the Order requires:
• No manufacture, processing, or use
of the microorganism other than in a
fermentation system that meets all of the
following conditions:
(A) Enzyme production occurs by
submerged fermentation (i.e., for
enzyme production, growth of the
microorganism occurs beneath the
surface of the liquid growth medium);
and
(B) Any fermentation of solid plant
material or insoluble substrate, to which
Trichoderma reesei fermentation broth
is added after the standard industrial
fermentation is completed, is initiated
only after the inactivation of the
microorganism as delineated in 40 CFR
725.422(d).
The proposed SNUR would designate
as a ‘‘significant new use’’ the absence
of these protective measures.
Potentially useful information: EPA
has determined that the results of the
following studies would help
characterize any potential human health
and environmental effects of the MCAN
substance if a manufacturer or processor
is considering submitting a SNUN for a
significant new use that would be
designated by this SNUR:
• Investigation of whether paracelsin
will be produced, and at what levels if
the genetically-modified T. reesei is
grown on various plant biomass
materials for different durations under
various fermentation conditions in
cellulosic biomass facilities.
• If paracelsin is produced, a study of
whether paracelsin would be denatured/
inactivated during production and
processing.
• If paracelsin is released from the
facility, a study of whether paracelsin
would be degraded/inactivated during
wastewater treatment.
• If released to the environment,
studies on the persistence, stability,
dissemination, accumulation, and the
potential resulting biological activity of
paracelsin with exposure to aquatic and
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terrestrial organisms in the
environment.
• Studies to determine the ability of
the MCAN microorganism to survive in
the environment relative to the survival
of the unmodified parent or recipient
strain, and to assess its competitiveness
with other fungi in the environment.
This study may require some
supplementation with one or more
carbon sources and the use of various
soil types.
• A study to determine survival of the
fungus during an anaerobic
fermentation for production of ethanol
by an ethanologen, and survival of the
fungus during ethanol distillation or at
the distillation temperature for ethanol.
Although the Order does not require
these tests, the Order’s restrictions
remain in effect until the Order is
modified or revoked by EPA based on
submission of this or other relevant
information.
CFR citation: 40 CFR 725.1081.
V. Rationale and Objectives of the
Proposed Rule
A. Rationale
During review of the PMNs and
MCAN submitted for the chemical
substances that are the subject to these
proposed SNURs, EPA concluded that
regulation was warranted under TSCA
section 5(e), pending the development
of information sufficient to make
reasoned evaluations of the health or
environmental effects of the chemical
substances. The basis for such findings
is outlined in Unit IV. Based on these
findings, TSCA section 5(e) Orders
requiring the use of appropriate
exposure controls were negotiated with
the PMN and MCAN submitters. As a
general matter, EPA believes it is
necessary to follow the TSCA Orders
with a SNUR that identifies the absence
of those protective measures as
significant new uses to ensure that all
manufacturers and processors—not just
the original submitter—are held to the
same standard.
B. Objectives
EPA is proposing these SNURs for
specific chemical substances which
have undergone premanufacture review
because the Agency wants:
• To identify as significant new uses
any manufacturing, processing, use,
distribution in commerce, or disposal
that does not conform to the restrictions
imposed by the underlying TSCA
Orders, consistent with TSCA section
5(f)(4).
• To have an opportunity to review
and evaluate data submitted in a SNUN
before the notice submitter begins
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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 (or MCAN, as
applicable). Therefore, for chemical
substances for which an NOC has not
been submitted EPA concludes that the
designated significant new uses are not
ongoing.
When chemical substances identified
in this proposed rule are added to the
TSCA Inventory, EPA recognizes that,
before the rule is effective, other persons
might engage in a use that has been
identified as a significant new use.
However, TSCA Orders have been
issued for these chemical substances
and the PMN and MCAN submitters are
prohibited by the TSCA Orders from
undertaking activities which would be
designated as significant new uses. The
identities of many of the chemical
substances subject to this proposed rule
have been claimed as confidential per
40 CFR 720.85 or 40 CFR 725.85 (for the
microorganism). 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 June 11,
2021 as the cutoff date for determining
whether the new use is ongoing. The
objective of EPA’s approach is to ensure
that a person cannot defeat a SNUR by
initiating a significant new use before
the effective date of the final rule.
In the unlikely event that a person
began commercial manufacture or
processing of the chemical substances
for a significant new use identified as of
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
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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
information to be submitted to EPA at
the time of submission of the SNUN.
In the absence of a rule, TSCA Order,
or consent agreement under TSCA
section 4 covering the chemical
substance, persons are required only to
submit information in their possession
or control and to describe any other
information known or reasonably
ascertainable (see 40 CFR 720.50 or 40
CFR 725.160 [for the microorganism]).
However, upon review of PMNs and
SNUNs, the Agency has the authority to
require appropriate testing. Unit IV. lists
potentially useful information for the
SNURs listed in this document.
Descriptions of this information is
provided for informational purposes.
The potentially useful information
identified in Unit IV. will be useful to
EPA’s evaluation in the event that
someone submits a SNUN for the
significant new use.
EPA strongly encourages persons,
before performing any testing, to consult
with the Agency. Furthermore, pursuant
to TSCA section 4(h), which pertains to
reduction of testing in vertebrate
animals, EPA encourages consultation
with the Agency on the use of
alternative test methods and strategies
(also called New Approach
Methodologies, or NAMs), if available,
to generate the recommended test data.
EPA encourages dialog with Agency
representatives to help determine how
best the submitter can meet both the
data needs and the objective of TSCA
section 4(h). For more information on
alternative test methods and strategies
to reduce vertebrate animal testing, visit
https://www.epa.gov/assessing-andmanaging-chemicals-under-tsca/
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alternative-test-methods-and-strategiesreduce.
In some of the TSCA Orders for the
chemical substances identified in this
rule, EPA has established time limits in
view of the lack of data on the potential
health and environmental risks that may
be posed by the significant new uses or
increased exposure to the chemical
substances. These limits cannot be
exceeded unless the PMN submitter first
submits the results of specified tests that
would permit a reasoned evaluation of
the potential risks posed by these
chemical substances. The SNURs
contain the same time limits as the
TSCA Orders. Exceeding these
production limits is defined as a
significant new use. Persons who intend
to exceed the time limit must notify the
Agency by submitting a SNUN at least
90 days in advance of commencement of
non-exempt commercial manufacture or
processing.
Any request by EPA for the triggered
and pended testing described in the
TSCA Orders was made based on EPA’s
consideration of available screeninglevel data, if any, as well as other
available information on appropriate
testing for the PMN substances. Further,
any such testing request on the part of
EPA that includes testing on vertebrates
was made after consideration of
available toxicity information,
computational toxicology and
bioinformatics, and high-throughput
screening methods and their prediction
models.
The potentially useful information
listed in Unit IV. may not be the only
means of addressing the potential risks
of the chemical substance. However,
submitting a SNUN without any test
data or other information may increase
the likelihood that EPA will take action
under TSCA section 5(e) or 5(f). EPA
recommends that potential SNUN
submitters contact EPA early enough so
that they will be able to conduct the
appropriate tests.
SNUN submitters should be aware
that EPA will be better able to evaluate
SNUNs which provide detailed
information on the following:
• Human exposure and
environmental release that may result
from the significant new use of the
chemical substances.
• Information on risks posed by the
chemical substances compared to risks
posed by potential substitutes.
VIII. SNUN Submissions
According to 40 CFR 721.1(c), persons
submitting a SNUN must comply with
the same notification requirements and
EPA regulatory procedures as persons
submitting a PMN, including
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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.
According to 40 CFR 725.900, persons
submitting an MCAN for a significant
new use of a microorganism must
comply with the same notification
requirements and EPA regulatory
procedures as persons submitting an
MCAN for a new microorganism,
including submission of test data on
health and environmental effects as
described in 40 CFR 725.160. E–PMN
software is available electronically at
https://www.epa.gov/reviewing-newchemicals-under-toxic-substancescontrol-act-tsca.
IX. Economic Analysis
EPA has evaluated the potential costs
of establishing SNUN requirements for
potential manufacturers and processors
of the chemical substances subject to
this proposed rule. EPA’s complete
economic analysis is available in the
docket for this rulemaking.
X. Statutory and Executive Order
Reviews
Additional information about these
statutes and Executive orders can be
found at https://www.epa.gov/lawsregulations-and-executive-orders.
A. Executive Order 12866: Regulatory
Planning and Review and Executive
Order 13563: Improving Regulations
and Regulatory Review
This action proposes to establish
SNURs for several new chemical
substances that were the subject of
PMNs and an MCAN. The Office of
Management and Budget (OMB) has
exempted these types of actions from
review under Executive Orders 12866
(58 FR 51735, October 4, 1993) and
13563 (76 FR 3821, January 21, 2011).
B. Paperwork Reduction Act (PRA)
According to the PRA (44 U.S.C. 3501
et seq.), an agency may not conduct or
sponsor, and a person is not required to
respond to a collection of information
that requires OMB approval under PRA,
unless it has been approved by OMB
and displays a currently valid OMB
control number. The OMB control
numbers for EPA’s regulations in title 40
of the CFR, after appearing in the
Federal Register, are listed in 40 CFR
part 9, and included on the related
collection instrument or form, if
applicable.
The information collection activities
associated with SNURs have already
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been approved by OMB under the PRA
and assigned OMB control number
2070–0012 (EPA ICR No. 574). This
proposed rule does not contain any
burden requiring additional OMB
approval. If an entity were to submit a
SNUN to the Agency, the annual burden
is estimated to average between 30 and
170 hours per response. This burden
estimate includes the time needed to
review instructions, search existing data
sources, gather and maintain the data
needed, and complete, review, and
submit the required SNUN.
Send any comments about the
accuracy of the burden estimate, and
any suggested methods for minimizing
respondent burden, including using
automated collection techniques, to the
Director, Regulatory Support Division,
Office of Mission Support (2822T),
Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC
20460–0001. Please remember to
include the OMB control number in any
correspondence, but do not submit any
completed forms to this address.
C. Regulatory Flexibility Act (RFA)
Pursuant to the RFA section 605(b) (5
U.S.C. 601 et seq.), the Agency hereby
certifies that promulgation of these
SNURs would not have a significant
adverse economic impact on a
substantial number of small entities.
The requirement to submit a SNUN
applies to any person (including small
or large entities) who intends to engage
in any activity described in the final
rule as a ‘‘significant new use.’’ Because
these uses are ‘‘new,’’ based on all
information currently available to EPA,
it appears that no small or large entities
presently engage in such activities. A
SNUR requires that any person who
intends to engage in such activity in the
future must first notify EPA by
submitting a SNUN. EPA’s experience to
date is that, in response to the
promulgation of SNURs covering over
1,000 chemicals, the Agency receives
only a small number of notices per year.
For example, the number of SNUNs
received was seven in Federal fiscal
year (FY) 2013, 13 in FY2014, six in
FY2015, 10 in FY2016, 14 in FY2017,
and 18 in FY2018 and only a fraction of
these were from small businesses. In
addition, the Agency currently offers
relief to qualifying small businesses by
reducing the SNUN submission fee from
$16,000 to $2,800. This lower fee
reduces the total reporting and
recordkeeping of cost of submitting a
SNUN to about $10,116 for qualifying
small firms. Therefore, the potential
economic impacts of complying with
this proposed SNUR are not expected to
be significant or adversely impact a
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substantial number of small entities. In
a SNUR that published in the Federal
Register of June 2, 1997 (62 FR 29684)
(FRL–5597–1), the Agency presented its
general determination that final SNURs
are not expected to have a significant
economic impact on a substantial
number of small entities, which was
provided to the Chief Counsel for
Advocacy of the Small Business
Administration.
D. Unfunded Mandates Reform Act
(UMRA)
Based on EPA’s experience with
proposing and finalizing SNURs, State,
local, and Tribal governments have not
been impacted by these rulemakings,
and EPA does not have any reasons to
believe that any State, local, or Tribal
government will be impacted by this
action. As such, EPA has determined
that this proposed rule would not
impose any enforceable duty, contain
any unfunded mandate, or otherwise
have any effect on small governments
subject to the requirements of UMRA
sections 202, 203, 204, or 205 (2 U.S.C.
1501 et seq.).
E. Executive Order 13132: Federalism
This action would not have a
substantial direct effect on States, on the
relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government, as specified in
Executive Order 13132 (64 FR 43255,
August 10, 1999).
F. Executive Order 13175: Consultation
and Coordination With Indian Tribal
Governments
This action would not have Tribal
implications because it is not expected
to have substantial direct effects on
Indian Tribes. This action would not
significantly nor uniquely affect the
communities of Indian Tribal
governments, nor would it involve or
impose any requirements that affect
Indian Tribes. Accordingly, the
requirements of Executive Order 13175
(65 FR 67249, November 9, 2000), do
not apply to this action.
G. Executive Order 13045: Protection of
Children From Environmental Health
Risks and Safety Risks
This action is not subject to Executive
Order 13045 (62 FR 19885, April 23,
1997), because this is not an
economically significant regulatory
action as defined by Executive Order
12866, and this action does not address
environmental health or safety risks
disproportionately affecting children.
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H. Executive Order 13211: Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use
This action is not subject to Executive
Order 13211 (66 FR 28355, May 22,
2001), because this proposed rule is not
expected to affect energy supply,
distribution, or use.
I. National Technology Transfer and
Advancement Act (NTTAA)
This action does not involve any
technical standards subject to NTTAA
section 12(d) (15 U.S.C. 272 note).
J. Executive Order 12898: Federal
Actions To Address Environmental
Justice in Minority Populations and
Low-Income Populations
This action does not entail special
considerations of environmental justice
related issues as delineated by
Executive Order 12898 (59 FR 7629,
February 16, 1994).
List of Subjects in 40 CFR Parts 721 and
725
Environmental protection, Chemicals,
Hazardous substances, Reporting and
recordkeeping requirements.
Dated: June 4, 2021.
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 §§ 721.11571 through
721.11603 to subpart E to read as
follows:
■
Subpart E—Significant New Uses for
Specific Chemical Substances
*
*
*
*
*
*
*
*
*
Sec.
*
721.11571 Hindered amine alkyl ester
compounds (generic).
721.11572 N-alkyl-dialkyl piperidine
(generic).
721.11573 Tetraalkylpiperidinium halide
(generic).
721.11574 Tetraalkylpiperidinium
hydroxide (generic).
721.11575 Amidoamino quaternary
ammonium salt (generic).
721.11576 Tri alkyl, mono alkoxy, fatty acid
ester, ammonium salt (generic).
721.11577 Halogenated aromatic amine
(generic).
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721.11578 1,4-Benzenedicarboxylic acid,
1,4-dipentyl ester, branched and linear.
721.11579 Dialkyltin dialkylcarboxylate
(generic).
721.11580 Alkyltin dodecylthioester
(generic).
721.11581 Alkyltin tetradecylthioester
(generic).
721.11582 Undecanol, branched.
721.11583 Hydroxy alkanoic acid, compds.
with aminoalkoxyalcohol-epoxy
polymer-alkanolamine reaction products
(generic).
721.11584 1,3-Propanediol, 2-ethyl-2(hydroxymethyl)-, polymer with
ethyleneamine, 2-(chloromethyl)oxirane,
2-[[4-(1,1-dimethylethyl)phenoxy]
methyl]oxirane, 2,2′-[1,6-hexanediylbis
(oxymethylene)]bis[oxirane], 4,4′-(1methylethylidene)bis[phenol], alkyl
ether amine, and 2-[(2methylphenoxymethyl]oxirane (generic).
721.11585 Benzenepropanoic acid, 3-(2Hbenzotriazol-2-yl)-5-(1,1-dimethylethyl)4-hydroxy-2,2-bis(hydroxymethyl)butyl
ester.
721.11586 1-Octadecanaminium, N,Ndimethyl-N- [3-(triethoxysilyl)propyl]-,
chloride (1:1).
721.11587 2-Propenoic acid, 2-methyl-, 3methyl-3-buten-1-yl ester.
721.11588 Mixed metal oxide (generic).
721.11589 Amines, polyethylenepoly-,
triethylenetetramine fraction, polymers
with guanidine hydrochloride (1:1).
721.11590 Phenol, 4,4′-(1methylethylidene)bis-, polymer with
3,6,9,12-tetraoxatetradeca-1, 13-diene,
glycidyl ether.
721.11591 1,4-Benzenedicarboxylic acid,
1,4-bis(2-phenoxyethyl) ester.
721.11592 Poly(oxy-1,2-ethanediyl),
.alpha.-nonyl-.omega.-hydroxy-,
branched and linear.
721.11593 1-Butanamine, N-butyl-N[(triethoxysilyl)methyl]-.
721.11594 Alkenylamide (generic).
721.11595 Isoalkylaminium, N-isoalkyl, -N,
N-dimethyl chloride (generic).
721.11596 Aldehyde, polymer with mixed
alkane polyamines, 2,2′-[1,4alkanediylbis(oxyalkylene)]bis[oxirane],
2-(alkoxyalkyloxirane, 4,4′-(1-alkylidene)
bis[phenol], 2,2′-[(1-alkylidene)bis(4,1alkyleneoxyalkylene)]bis[oxirane] and 2(aryloxyalkyl)oxirane, acetate (salt)
(generic).
721.11597 Alkanedioic acid, compds. with
substituted arylalkylamine-arylalcohol
disubstituted alkane-the diglycidyl ether
of a arylalcohol disubstituted alkaneepichlorohydrin-aldehyde-2,2′(1alkylidene)bis[4,1-aryleneoxy(alkyl-2,1alkanediyl)oxyalkylene]]bis[oxirane]alkanepolyamine polymer-1-[[2-[(2aminoalkyl)amino]alkyl]amino]-3aryloxy-2-alcohol reaction products
(generic).
721.11598 Polyazaalkane with oxirane and
methyloxirane, haloalkane (generic).
721.11599 Dibromoalkyl ether
tetrabromobisphenol A (generic).
721.11600 Octonal, 7(or 8)-formyl-.
721.11601 Sulfonium, trisaryl-, 7,7-dialkyl2-heteropolycyclic-1-alkanesulfonate
(1:1) (generic).
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721.11602 Alkenoic acid, polymer with
(alkyl alkenyl) polyether (generic).
*
*
*
*
*
§ 721.11571 Hindered amine alkyl ester
compounds (generic).
(a) Chemical substance and
significant new uses subject to reporting.
The chemical substance generically
identified as hindered amine alkyl ester
compounds (PMN P–16–167) 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), (a)(2)(i) through (iv),
(a)(3) through (6), 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 of 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 50. For purposes of
§ 721.63(a)(6), the airborne form(s) of
the substance include particulate
(including solids or liquid droplets),
gas/vapor (all substances in gas form),
and combination gas/vapor and
particulate (gas and liquid/solid
physical states are present).
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (d), (f), (g)(1), (g)(2)(i) through
(v), (g)(3)(i) and (ii), (g)(4)(i) through
(iii), and (g)(5). For purposes of
§ 721.72(g)(1), this substance may cause:
Skin irritation; respiratory
complications; central nervous system
effects; blood effects. Alternative hazard
and warning statements that meet the
criteria of the Globally Harmonized
System and OSHA Hazard
Communication Standard may be used.
(iii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4) and
(c)(4), where N=1.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (h), and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain
modification requirements. The
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provisions of § 721.185 apply to this
section.
§ 721.11572
(generic).
N-alkyl-dialkyl piperidine
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as N-alkyl-dialkyl piperidine
(PMN P–16–419) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section. The requirements of this
section do not apply to quantities of the
substance after they have been
completely reacted (cured).
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i) through (iii),
(a)(3) through (6), (b), and (c). When
determining which persons are 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 gas/vapor (all
substances in the gas form). For
purposes of § 721.63(b), the
concentration is set at 1.0%.
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (f), (g)(1), (g)(2)(i) through (v),
(g)(3)(ii), (g)(4), and (g)(5). For purposes
of § 721.72(e), the concentration is set at
1.0%. For purposes of § 721.72(g)(1),
this substance may cause: Skin
corrosion; serious eye damage; acute
toxicity; specific target organ toxicity.
For purposes of § 721.72(g)(4), notice to
users: Water release restrictions apply.
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(h).
(iv) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4) and
(c)(4), where N=286.
(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 (i), and (k) are
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applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain
modification requirements. The
provisions of § 721.185 apply to this
section.
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§ 721.11573
(generic).
Tetraalkylpiperidinium halide
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as tetraalkylpiperidinium
halide (PMN P–16–423) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section. The
requirements of this section do not
apply to quantities of the substance after
they have been completely reacted
(cured).
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i), (a)(3), (b), and
(c). When determining which persons
are 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. For purposes
of § 721.63(b), the concentration is set at
1.0%.
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (f), (g)(1), (g)(2)(i) through (iii)
and (v), (g)(3)(ii), (g)(4), and (g)(5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1), the substance
may cause: Acute toxicity; specific
target organ toxicity; reproductive
toxicity. For purposes of § 721.72(g)(4),
notice to users: Water release
restrictions apply. 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(g).
(iv) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4) and
(c)(4), where N=20.
(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 (i), and (k) are
applicable to manufacturers and
processors of this substance.
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(2) Limitation or revocation of certain
modification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.11574 Tetraalkylpiperidinium
hydroxide (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as tetraalkylpiperidinium
hydroxide (PMN P–16–424) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section. The
requirements of this section do not
apply to quantities of the substance after
they have been completely reacted
(cured).
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i) through (iii),
(a)(3), (b), and (c). When determining
which persons are 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. For
purposes of § 721.63(b), the
concentration is set at 1.0%.
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (f), (g)(1), (g)(2)(i) through (v),
(g)(3)(ii), (g)(4), and (g)(5). For purposes
of § 721.72(e), the concentration is set at
1.0%. For purposes of § 721.72(g)(1),
this substance may cause: Skin
corrosion; serious eye damage; acute
toxicity; specific target organ toxicity;
reproductive toxicity. For purposes of
§ 721.72(g)(4), notice to users: Water
release restrictions apply. 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).
(iv) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4) and
(c)(4), where N=20.
(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 (i), and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain
modification requirements. The
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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).
§ 721.11575 Amidoamino quaternary
ammonium salt (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as amidoamino quaternary
ammonium salt (PMN P–17–235) 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) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k).
(ii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4) and
(c)(4), where N=44.
(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), (i), and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitation 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)(i) of this section.
§ 721.11576 Tri alkyl, mono alkoxy, fatty
acid ester, ammonium salt (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as tri alkyl, mono alkoxy,
fatty acid ester, ammonium salt (PMN
P–18–226) 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(k).
(ii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4) and
(c)(4), where N=44.
(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), (i), and (k) are
applicable to manufacturers and
processors of this substance.
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(2) Limitation 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)(i) of this section.
§ 721.11577
(generic).
Halogenated aromatic amine
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as halogenated aromatic
amine (PMN P–17–259) 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 (cured).
(2) The significant new uses are:
(i) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4) and
(c)(4), where N=1.
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c), and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain
modification requirements. The
provisions of § 721.185 apply to this
section.
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§ 721.11578 1,4-Benzenedicarboxylic acid,
1,4-dipentyl ester, branched and linear.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
1,4-benzenedicarboxylic acid, 1,4dipentyl ester, branched and linear
(PMN P–18–43; CAS No. 2097734–13–7)
is subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section. The
requirements of this section do not
apply to quantities of the PMN
substance after they have been
completely reacted (cured).
(2) The significant new uses are:
(i) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4) and
(c)(4), where N=2.
(ii) [Reserved]
(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 (k) are
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applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain
modification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.11579
(generic).
Dialkyltin dialkylcarboxylate
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as dialkyltin
dialkylcarboxylate (PMN P–18–178) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section. The
requirements of this section do not
apply to quantities of the substance after
they have been completely reacted
(cured).
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(3) through (6), and (c).
When determining which persons are
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
(including solids or liquid droplets).
(ii) Industrial, commercial, and
consumer activities. It is a significant
new use to use the substance other than
as a stabilizer for PVC compounds.
(iii) Release to water. Requirements as
specified in § 721.90(a)(1), (b)(1), and
(c)(1).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (e), (i), and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain
modification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.11580
(generic).
Alkyltin dodecylthioester
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
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identified as alkyltin dodecylthioester
(PMN P–18–217) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section. The requirements of this
section do not apply to quantities of the
substance after they have been
completely reacted (cured).
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(3), and (c). When
determining which persons are 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) Industrial, commercial, and
consumer activities. It is a significant
new use to use the substance other than
as a stabilizer for PVC compounds.
(iii) Release to water. Requirements as
specified in § 721.90(a)(1), (b)(1), and
(c)(1).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (e), (i), and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain
modification requirements. The
provisions of § 721.185 apply to this
section
§ 721.11581
(generic).
Alkyltin tetradecylthioester
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as alkyltin tetradecylthioester
(PMN P–18–218) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section. The requirements of this
section do not apply to quantities of the
substance after they have been
completely reacted (cured).
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(3), and (c). When
determining which persons are 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
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considered and implemented to prevent
exposure, where feasible.
(ii) Industrial, commercial, and
consumer activities. It is a significant
new use to use the substance other than
as a stabilizer for PVC compounds.
(iii) Release to water. Requirements as
specified in § 721.90(a)(1), (b)(1), and
(c)(1).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (e), (i), and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain
modification requirements. The
provisions of § 721.185 apply to this
section
§ 721.11582
Undecanol, branched.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
undecanol, branched (PMN P–18–256)
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 PMN
substance after they have been
completely reacted (cured).
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(g).
(ii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4) and
(c)(4), where N=4.
(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), (i), and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain
modification requirements. The
provisions of § 721.185 apply to this
section.
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§ 721.11583 Hydroxy alkanoic acid,
compds. with aminoalkoxyalcohol-epoxy
polymer-alkanolamine reaction products
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as hydroxy alkanoic acid,
compds. with aminoalkoxyalcoholepoxy polymer-alkanolamine reaction
products (PMN P–18–283) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
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(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i) through (iii),
(a)(3), (b), 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. For purposes
of § 721.63(b), the concentration is set at
1%.
(ii) Hazard communication.
Requirements as specified in § 721.72
(a) through (f), (g)(1), (g)(2)(i) and (v),
(g)(3)(ii), (g)(4)(iii), and (g)(5). For
purposes of § 721.72(e), the
concentration is set at 1%. For purposes
of § 721.72(g)(1), this substance may
cause: Skin irritation; skin sensitization;
eye irritation; specific target organ
toxicity; reproductive toxicity.
Alternative hazard and warning
statements that meet the criteria of the
Globally Harmonized System and OSHA
Hazard Communication Standard may
be used.
(iii) Release to water. Requirements as
specified in § 721.90(a)(1), (b)(1), and
(c)(1).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (h), and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain
modification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.11584 1,3-Propanediol, 2-ethyl-2(hydroxymethyl)-, polymer with
ethyleneamine, 2-(chloromethyl)oxirane, 2[[4-(1,1-dimethylethyl)
phenoxy]methyl]oxirane, 2,2′-[1,6hexanediylbis(oxymethylene)]bis[oxirane],
4,4′-(1-methylethylidene)bis[phenol], alkyl
ether amine, and 2-[(2methylphenoxymethyl]oxirane (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as 1,3-propanediol, 2-ethyl-2(hydroxymethyl)-, polymer with
ethyleneamine, 2(chloromethyl)oxirane, 2-[[4-(1,1dimethylethyl)phenoxy]methyl]oxirane,
2,2′-[1,6-hexanediylbis(oxymethylene)]
bis[oxirane], 4,4′-(1-methylethylidene)
bis[phenol], alkyl ether amine, and 2[(2-methylphenoxymethyl]oxirane
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(PMN P–18–298) 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 (cured).
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(o). It is a
significant new use to manufacture,
process, or use the PMN substance for
an application method that results in
inhalation exposure.
(ii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4) and
(c)(4), where N=50.
(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), (i), and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain
modification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.11585 Benzenepropanoic acid, 3(2H-benzotriazol-2-yl)-5-(1,1-dimethylethyl)4-hydroxy-2,2-bis(hydroxymethyl)butyl
ester.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
benzenepropanoic acid, 3-(2Hbenzotriazol-2-yl)-5-(1,1-dimethylethyl)4-hydroxy-2,2-bis(hydroxymethyl)butyl
ester (PMN P–18–310; CAS No.
2101609–93–0) 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
PMN substance after they have been
completely reacted (cured).
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i) through (iii),
(a)(3) through (6), 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
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(APF) of at least 1,000. For purposes of
§ 721.63(a)(6), the airborne form(s) of
the substance include gas/vapor and
particulate.
(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 0.16 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 whose § 721.30
requests to use the NCELs approach are
approved by EPA will be required to
follow NCELs provisions comparable to
those contained in the corresponding
TSCA section 5(e) consent order.
(B) [Reserved]
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (f), (g)(1), (g)(3)(ii), and (g)(5).
For purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1), this
substance may cause: Specific target
organ toxicity; reproductive toxicity.
Alternative hazard and warning
statements that meet the criteria of the
Globally Harmonized System and OSHA
Hazard Communication Standard may
be used.
(iii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4) and
(c)(4), where N=1.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (h), and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain
modification requirements. The
provisions of § 721.185 apply to this
section.
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§ 721.11586 1-Octadecanaminium, N,Ndimethyl-N- [3-(triethoxysilyl)propyl]-,
chloride (1:1).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
1-octadecanaminium, N,N-dimethyl-N[3-(triethoxysilyl)propyl]-, chloride (1:1)
(PMN P–18–318; CAS No. 62117–57–1)
is subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Hazard communication.
Requirements as specified in § 721.72(a)
through (f), (g)(1), (g)(3)(ii), and (g)(5).
For purposes of § 721.72(g)(1), this
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substance may cause: Skin irritation;
eye irritation; specific target organ
toxicity. For purposes of § 721.72(e), the
concentration is set at 1.0%. Alternative
hazard and warning statements that
meet the criteria of the Globally
Harmonized System and OSHA Hazard
Communication Standard may be used.
(ii) Industrial, commercial, and
consumer activities. It is a significant
new use to use the substance other than
as a surface treatment for added
lubricity and anti-static properties. It is
a significant new use to use the
substance in an application method that
results in inhalation exposure to
workers.
(iii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4) and
(c)(4), where N=1.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c), (f) through (i),
and (k) are applicable to manufacturers
and processors of this substance.
(2) Limitation or revocation of certain
modification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.11587 2-Propenoic acid, 2-methyl-, 3methyl-3-buten-1-yl ester.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
2-propenoic acid, 2-methyl-, 3-methyl-3buten-1-yl ester (PMN P–18–323; CAS
No. 156291–88–2) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section. The requirements of this
section do not apply to quantities of the
PMN substance after they have been
completely reacted (cured).
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i) through (iii),
(a)(3) through (6), 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 50. For purposes of
§ 721.63(a)(6), the airborne form(s) of
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the substance include particulate
(including solids or liquid droplets) and
gas/vapor (all substances in the gas
form).
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (d), (f), (g)(1), (g)(2)(i) through
(v), (g)(3)(i) and (ii), (g)(4)(i) through
(iii), and (g)(5). For purposes of
§ 721.72(g)(1), this substance may cause:
skin irritation; developmental effects;
systemic effects; respiratory effects; skin
sensitization; respiratory sensitization.
Alternative hazard and warning
statements that meet the criteria of the
Globally Harmonized System and
Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and
consumer use. Requirements as
specified in § 721.80(k).
(iv) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4) and
(c)(4), where N=98.
(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 (i), and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitation 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)(iii) of this section.
§ 721.11588
Mixed metal oxide (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as mixed metal oxide (PMN
P–18–327) is subject to reporting under
this section for the significant new uses
described in paragraph (a)(2) of this
section. The requirements of this section
do not apply to quantities of the
substance after they have been
completely reacted (cured).
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(3) through (6), 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
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must provide a National Institute for
Occupational Safety and Health
(NIOSH) assigned protection factor
(APF) of at least 1,000. For purposes of
§ 721.63(a)(6), the airborne form(s) of
the substance include particulate
(including solids or liquid droplets).
(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 0.1 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 whose § 721.30
requests to use NCELs approach 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 (d), (f), (g)(1), (g)(2), and (g)(5).
For purposes of § 721.72(g)(1), this
substance may cause: cancer; skin
sensitization; respiratory sensitization;
specific target organ toxicity.
Alternative hazard and warning
statements that meet the criteria of the
Globally Harmonized System and OSHA
Hazard Communication Standard may
be used. For purposes of § 721.72(g)(2),
when using this substance: avoid skin
contact, avoid breathing substance,
avoid ingestion, use respiratory
protection or maintain workplace
airborne concentrations at or below an
8-hour time-weighted average of 0.1 mg/
m3, and use skin protection.
(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 (h) are applicable
to manufacturers and processors of this
substance.
(2) Limitation or revocation of certain
modification requirements. The
provisions of § 721.185 apply to this
section.
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§ 721.11589 Amines, polyethylenepoly-,
triethylenetetramine fraction, polymers with
guanidine hydrochloride (1:1).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
amines, polyethylenepoly-,
triethylenetetramine fraction, polymers
with guanidine hydrochloride (1:1)
(PMN P–18–347; CAS No. 1902936–67–
7) is subject to reporting under this
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section for the significant new uses
described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1) and (3), (b), 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. For purposes
of § 721.63(b), the concentration is set at
1%.
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (f), (g)(1), (g)(2)(i) and (v),
(g)(3)(i) and (ii), (g)(4)(i), and (g)(5). For
purposes of § 721.72(e), the
concentration is set at 1%. For purposes
of § 721.72(g)(1), this substance may
cause: acute toxicity; skin sensitization;
specific target organ toxicity.
Alternative hazard and warning
statements that meet the criteria of the
Globally Harmonized System and OSHA
Hazard Communication Standard may
be used.
(iii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4) and
(c)(4), where N=2.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (h), and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain
notification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.11590 Phenol, 4,4′-(1methylethylidene)bis-, polymer with
3,6,9,12-tetraoxatetradeca-1, 13-diene,
glycidyl ether.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
phenol, 4,4′-(1-methylethylidene)bis-,
polymer with 3,6,9,12-tetraoxatetradeca1, 13-diene, glycidyl ether (PMN P–18–
405; CAS No. 647028–24–8) 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 (cured).
(2) The significant new uses are:
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(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(o). It is a
significant new use to manufacture,
process, or use the PMN substance in a
manner that results in inhalation
exposure.
(ii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4) and
(c)(4), where N=1.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c), (i), and (k) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitation or revocation of certain
modification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.11591 1,4-Benzenedicarboxylic acid,
1,4-bis(2-phenoxyethyl) ester.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
1,4-benzenedicarboxylic acid, 1,4-bis(2phenoxyethyl) ester (PMN P–19–36;
CAS No. 25900–07–6) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section. The
requirements of this section do not
apply to quantities of the PMN
substance after they have been
completely reacted (cured).
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i), (a)(3) through
(6), 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 of 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 1,000. For purposes of
§ 721.63(a)(6), the airborne form(s) of
the substance include particulate
(including solids or liquid droplets).
(ii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4) and
(c)(4), where N=3.
(b) Specific requirements. The
provisions of subpart A of this part may
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 (e) and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain
modification requirements. The
provisions of § 721.185 apply to this
section.
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§ 721.11592 Poly(oxy-1,2-ethanediyl),
.alpha.-nonyl-.omega.-hydroxy-, branched
and linear.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
poly(oxy-1,2-ethanediyl), .alpha.-nonyl.omega.-hydroxy-, branched and linear
(PMN P–19–52; CAS No. 2242406–13–7)
is subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i) through (iii),
(a)(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 1,000. For purposes of
§ 721.63(a)(6), the airborne form(s) of
the substance include particulate
(including solids or liquid droplets). For
purposes of § 721.63(b), the
concentration is set at 1%.
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (f), (g)(1), (g)(2)(i) through (v),
(g)(3)(i) and (ii), and (g)(5). For purposes
of § 721.72(e), the concentration is set at
1%. For purposes of § 721.72(g)(1), this
substance may cause: Skin irritation;
respiratory complications; internal
organ effects; eye corrosion. Alternative
hazard and warning statements that
meet the criteria of the Globally
Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and
consumer use. It is a significant new use
to use the substance where the
concentration of the substance in the
product formulation intended for
distribution in commerce exceeds 1%
by weight.
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(iv) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4) and
(c)(4), where N=34.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i), and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain
modification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.11593 1-Butanamine, N-butyl-N[(triethoxysilyl)methyl]-.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
1-Butanamine, N-butyl-N[(triethoxysilyl)methyl]- (PMN P–19–53;
CAS No. 35501–23–6) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section. The
requirements of this section do not
apply to quantities of the substance after
they have been completely reacted
(cured).
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1) 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) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(f) and (o). It is a
significant new use to process and use
the substance other than in a liquid
formulation.
(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 (e), and (i) are
applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain
modification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.11594
Alkenylamide (generic).
(a) Chemical substance and
significant new uses subject to reporting.
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(1) The chemical substance generically
identified as alkenylamide (PMN P–19–
77) 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(k).
(ii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4) and
(c)(4), where N=4.
(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), (i), and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitation 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.
§ 721.11595 Isoalkylaminium, N-isoalkyl,
-N, N-dimethyl chloride (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as isoalkylaminium, Nisoalkyl, -N, N-dimethyl chloride (PMN
P–19–131) 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) Hazard communication.
Requirements as specified in § 721.72(a)
through (f), (g)(1), (g)(3)(ii), and (g)(5).
For purposes of § 721.72(e), the
concentration is set at 1%. For purposes
of § 721.72(g)(1), this substance may
cause: Skin irritation; eye irritation;
specific target organ toxicity.
Alternative hazard and warning
statements that meet the criteria of the
Globally Harmonized System and OSHA
Hazard Communication Standard may
be used.
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(o). It is significant
new use to manufacture, process, or use
the PMN substance in a manner that
results in inhalation exposure.
(iii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4) and
(c)(4), where N=1.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
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(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c), (f) through (i),
and (k) are applicable to manufacturers
and processors of this substance.
(2) Limitation or revocation of certain
modification requirements. The
provisions of § 721.185 apply to this
section.
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§ 721.11596 Aldehyde, polymer with mixed
alkane polyamines, 2,2′-[1,4alkanediylbis(oxyalkylene)]bis[oxirane], 2(alkoxyalkyloxirane, 4,4′-(1alkylidene)bis[phenol], 2,2′-[(1alkylidene)bis(4,1alkyleneoxyalkylene)]bis[oxirane] and 2(aryloxyalkyl)oxirane, acetate (salt)
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as aldehyde, polymer with
mixed alkane polyamines, 2,2′-[1,4alkanediylbis(oxyalkylene)]bis[oxirane],
2-(alkoxyalkyloxirane, 4,4′-(1alkylidene)bis[phenol], 2,2′-[(1alkylidene)bis(4,1alkyleneoxyalkylene)]bis[oxirane] and
2-(aryloxyalkyl)oxirane, acetate (salt)
(PMN P–19–143) 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 (cured) or destroyed.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(o). It is a
significant new use to manufacture,
process, or use the PMN substance in a
manner that results in inhalation
exposure to either the PMN substance or
to formaldehyde.
(ii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4) and
(c)(4), where N=1.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c), (i), and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain
modification requirements. The
provisions of § 721.185 apply to this
section.
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§ 721.11597 Alkanedioic acid, compds.
with substituted arylalkylamine-arylalcohol
disubstituted alkane-the diglycidyl ether of
a arylalcohol disubstituted alkaneepichlorohydrin-aldehyde-2,2′[(1alkylidene)bis[4,1-aryleneoxy(alkyl-2,1alkanediyl)oxyalkylene]]bis[oxirane]alkanepolyamine polymer-1-[[2-[(2aminoalkyl)amino]alkyl]amino]-3-aryloxy-2alcohol reaction products (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as alkanedioic acid, compds.
with substituted arylalkylaminearylalcohol disubstituted alkane-the
diglycidyl ether of a arylalcohol
disubstituted alkane-epichlorohydrinaldehyde-2,2′[(1-alkylidene)bis[4,1aryleneoxy(alkyl-2,1alkanediyl)oxyalkylene]]bis[oxirane]alkanepolyamine polymer-1-[[2-[(2aminoalkyl)amino]alkyl]amino]-3aryloxy-2-alcohol reaction products
(PMN P–19–144) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section. The requirements of this
section do not apply to quantities of the
substance after they have been
completely reacted (cured) or destroyed.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(o). It is a
significant new use to manufacture,
process, or use the PMN substance in a
manner that results in inhalation
exposure to either the PMN substance or
to formaldehyde.
(ii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4) and
(c)(4), where N=1.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c), (i), and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain
modification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.11598 Polyazaalkane with oxirane
and methyloxirane, haloalkane (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as polyazaalkane with oxirane
and methyloxirane, haloalkane (PMN P–
19–145) is subject to reporting under
this section for the significant new uses
described in paragraph (a)(2) of this
section. The requirements of this section
do not apply to quantities of the
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substance after they have been
completely reacted (cured).
(2) The significant new uses are:
(i) Hazard communication.
Requirements as specified in § 721.72(a)
through (f), (g)(1), and (g)(5). For
purposes of § 721.72(e), the
concentration is set at 1%. For purposes
of § 721.72(g)(1), this substance may
cause: reproductive toxicity; specific
target organ toxicity. Alternative hazard
and warning statements that meet the
criteria of the Globally Harmonized
System and OSHA Hazard
Communication Standard may be used.
(ii) Industrial, commercial, and
consumer activities. It is a significant
new use to manufacture, process, or use
the PMN substance in a manner that
results in inhalation exposure.
(iii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4) and
(c)(4), where N=26.
(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), (f) through (h),
(i) and (k) are applicable to
manufacturers and processors of this
substance.
(2) Limitation or revocation of certain
modification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.11599 Dibromoalkyl ether
tetrabromobisphenol A (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as dibromoalkyl ether
tetrabromobisphenol A (PMN P–19–153)
is subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i) and (iii), (a)(3),
and (c). When determining which
persons are reasonably likely to be
exposed as required for § 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 (f), (g)(1), (g)(3)(ii), and (g)(5).
For purposes of § 721.72(e), the
concentration is set at 1%. For purposes
of § 721.72(g)(1), this substance may
cause: eye irritation; carcinogenicity;
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reproductive toxicity; specific target
organ toxicity. Alternative hazard and
warning statements that meet the
criteria of the Globally Harmonized
System and OSHA Hazard
Communication Standard may be used.
(iii) Release to water. Requirements as
specified in § 721.90(a)(1), (b)(1), and
(c)(1).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (h), and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain
modification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.11600
Octonal, 7(or 8)-formyl-.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
Octonal, 7(or 8)-formyl- (PMN P–20–29;
CAS No. 1607842–40–9) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4) and
(c)(4), where N=17.
(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 (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain
modification requirements. The
provisions of § 721.185 apply to this
section.
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§ 721.11601 Sulfonium, trisaryl-, 7,7dialkyl-2-heteropolycyclic-1alkanesulfonate (1:1) (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as sulfonium, trisaryl-, 7,7dialkyl-2-heteropolycyclic-1alkanesulfonate (1:1) (PMN P–20–42) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section. The
requirements of this section do not
apply to quantities of the substance after
they have been completely reacted or
adhered (during the photolithographic
process) onto a semiconductor wafer
surface or similar manufactured article
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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), (a)(2)(i) and (iii), (a)(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 (e), (g)(1), (g)(2)(i) through (v),
(g)(3)(i) and (ii), and (g)(5). For purposes
of § 721.72(e), the concentration is set at
1%. For purposes of § 721.72(g)(1), this
substance may cause: Skin irritation;
acute toxicity; skin sensitization; serious
eye damage; specific target organ
toxicity; neurotoxicity; genetic toxicity;
reproductive toxicity. Alternative
hazard and warning statements that
meet the criteria of the Globally
Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 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
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 (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitation 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.
§ 721.11602 Alkenoic acid, polymer with
(alkyl alkenyl) polyether (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as alkenoic acid, polymer
with (alkyl alkenyl) polyether (PMN P–
20–104) is subject to reporting under
PO 00000
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31261
this section for the significant new uses
described in paragraph (a)(2) of this
section. The requirements of this section
do not apply to quantities of the
substance after they have been
completely reacted (cured).
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(o). It is a
significant new use to manufacture,
process, or use the substance in a
manner that results in inhalation
exposure.
(ii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4) and
(c)(4), where N=75.
(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), (i), and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain
modification requirements. The
provisions of § 721.185 apply to this
section.
*
*
*
*
*
PART 725— REPORTING
REQUIREMENTS AND REVIEW
PROCESSES FOR MICROORGANISMS
3. The authority citation for part 725
continues to read as follows:
■
Authority: 15 U.S.C. 2604, 2607, 2613, and
2625.
■
4. Add § 725.1081 to read as follows:
§ 725.1081
Trichoderma reesei (generic).
(a) Microorganism and significant new
uses subject to reporting. (1) The
genetically-modified microorganism
generically identified as Trichoderma
reesei modified (MCAN J–16–26) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2)(i) It is a significant new use to
manufacture, process, or use the
microorganism other than in a
fermentation system that meets all of the
following conditions:
(A) Enzyme production occurs by
submerged fermentation (i.e., for
enzyme production, growth of the
microorganism occurs beneath the
surface of the liquid growth medium);
and
(B) Any fermentation of solid plant
material or insoluble substrate to which
Trichoderma reesei fermentation broth
is added after the standard industrial
fermentation is completed is initiated
only after the inactivation of the
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Federal Register / Vol. 86, No. 111 / Friday, June 11, 2021 / Proposed Rules
microorganism as delineated in
§ 725.422(d).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart L of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 725.950(b)(2) through (4) are
applicable to manufacturers and
processors of this microorganism.
(2) Modification or revocation of
certain notification requirements. The
provisions of § 725.984 apply to this
section.
*
*
*
*
*
[FR Doc. 2021–12147 Filed 6–10–21; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
50 CFR Part 648
[Docket No. 210607–0122]
RIN 0648–BK55
Fisheries of the Northeastern United
States; Northeast Multispecies
Fishery; 2021–2023 Small-Mesh
Multispecies Specifications
National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
ACTION: Proposed rule; request for
comments.
AGENCY:
NMFS proposes small-mesh
multispecies specifications for the 2021
fishing year, and projected
specifications for fishing years 2022 and
2023, as recommended by the New
England Fishery Management Council.
This action also proposes changes to
whiting possession limits on certain
trips and would restore the in-season
adjustment trigger for northern red hake.
This action is necessary to establish
allowable harvest levels and other
management measures consistent with
the most recent scientific information.
SUMMARY:
This rule also informs the public of the
proposed fishery specifications and
provides an opportunity for comment.
DATES: Comments must be received by
June 28, 2021.
ADDRESSES: You may submit comments
on this document, identified by NOAA–
NMFS–2021–0043, by the following
method:
Electronic Submission: Submit all
electronic public comments via the
Federal e-Rulemaking Portal.
1. Go to https://www.regulations.gov,
and enter ‘‘NOAA–NMFS–2021–0043’’
in the Search box;
2. Click the ‘‘Comment’’ icon,
complete the required fields; and
3. Enter or attach your comments.
Instructions: Comments sent by any
other method, to any other address or
individual, or received after the end of
the comment period, may not be
considered by NMFS. All comments
received are a part of the public record
and will generally be posted for public
viewing on www.regulations.gov
without change. All personal identifying
information (e.g., name, address, etc.),
confidential business information, or
otherwise sensitive information
submitted voluntarily by the sender will
be publicly accessible. NMFS will
accept anonymous comments (enter
‘‘N/A’’ in the required fields if you wish
to remain anonymous).
The New England Fishery
Management Council prepared a draft
environmental assessment (EA) for this
action that describes the proposed
measures and other considered
alternatives. The EA also provides an
economic analysis, as well as an
analysis of the biological, economic, and
social impacts of the proposed measures
and other considered alternatives.
Copies of the specifications document,
including the EA and information on
the economic impacts of the proposed
measures, are available upon request
from Thomas A. Nies, Executive
Director, New England Fishery
Management Council, 50 Water Street,
Newburyport, MA 01950. This
document is also accessible via the
internet at https://www.nefmc.org/
library/2021-2023-whitingspecifications.
FOR FURTHER INFORMATION CONTACT:
Cynthia Ferrio, Fishery Policy Analyst,
(978) 281–9180.
SUPPLEMENTARY INFORMATION:
Background
The small-mesh multispecies fishery
comprises three species of hakes that are
managed as five stocks: Northern and
southern silver hake; northern and
southern red hake; and offshore hake.
Southern silver hake and offshore hake
are often grouped together for
management purposes and collectively
referred to as ‘‘southern whiting.’’ The
New England Fishery Management
Council manages the small-mesh
multispecies fishery within the
Northeast Multispecies Fishery
Management Plan (FMP). This action
proposes catch limit specifications for
the 2021 small-mesh multispecies
fishery, and projects specifications for
fishing years 2022 and 2023, based on
the Council’s recommendations.
This action would also increase
whiting (silver hake and offshore hake)
possession limits on trips using gear
with less than 3-in (7.62-cm) mesh from
3,500 pounds (lb) (1,588 kilograms (kg))
or 7,500 lb (3,402 kg) to 15,000 lb (6,804
kg), and restore the in-season
adjustment trigger for northern red hake
to 90 percent from 37.9 percent. These
recommended changes reflect the most
recent stock assessment information
(September 2020), and are intended to
increase fishing flexibility, decrease
regulatory discards, and promote
rebuilding of the southern red hake
stock.
Proposed Specifications
This action proposes the Council’s
recommendations for 2021 and
projected 2022–2023 small-mesh
multispecies catch specifications, as
well as revised management measures
reduce regulatory discards. These
proposed catch limits would increase
annual quotas for southern whiting and
both red hake stocks, and decrease the
quota for northern silver hake (Table 1).
Specifications for fishing years 2022 and
2023 are projected to be the same as the
proposed 2021 limits.
jbell on DSKJLSW7X2PROD with PROPOSALS
TABLE 1—PROPOSED SMALL-MESH MULTISPECIES SPECIFICATIONS FOR FISHING YEARS 2021–2023 (METRIC TONS),
WITH THE PERCENT CHANGE IN THE TOTAL ALLOWABLE LANDINGS (TAL) FROM FISHING YEAR 2020
Overfishing
limit
Northern Red Hake ..............................................................
Northern Silver Hake ...........................................................
Southern Red Hake .............................................................
VerDate Sep<11>2014
18:55 Jun 10, 2021
Jkt 253001
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Acceptable
biological
catch
N/A
39,930
N/A
Fmt 4702
Sfmt 4702
Annual
catch limit
3,452
20,410
1,505
E:\FR\FM\11JNP1.SGM
3,278
19,387
1,429
11JNP1
TAL
1,405
17,457
422
Percent
change
+413
¥34
+89
]]>Agencies
[Federal Register Volume 86, Number 111 (Friday, June 11, 2021)]
[Proposed Rules]
[Pages 31239-31262]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-12147]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 721 and 725
[EPA-HQ-OPPT-2020-0588; FRL-10022-56]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances (21-
1.5e)
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) and a Microbial Commercial
Activity Notice (MCAN), and are also subject to Orders issued by EPA
pursuant to TSCA. The SNURs require persons who intend to manufacture
(defined by statute to include import) or process any of these chemical
substances for an activity that is proposed as a significant new use by
this rule to notify EPA at least 90 days before commencing that
activity. The required notification initiates EPA's evaluation of the
use, under the conditions of use for that chemical substance, within
the applicable review period. Persons may not commence manufacture or
processing for the significant new use until EPA has conducted a review
of the notice, made an appropriate determination on the notice, and has
taken such actions as are required by that determination.
DATES: Comments must be received on or before July 12, 2021.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2020-0588, 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, New Chemicals Division (7405M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(202) 564-4163; email address: [email protected].
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you manufacture,
process, or use the chemical substances contained in this proposed
rule. The following list of North American Industrial Classification
System (NAICS) codes is not intended to be exhaustive, but rather
provides a guide to help readers determine whether this document
applies to them. Potentially affected entities may include:
Manufacturers or processors of one or more subject
chemical substances (NAICS codes 325 and 324110), e.g., chemical
manufacturing and petroleum refineries.
This action may also affect certain entities through pre-existing
import certification and export notification rules under TSCA. Chemical
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import
provisions promulgated at 19 CFR 12.118 through 12.127 and 19 CFR
127.28. Chemical importers must certify that the shipment of the
chemical substance complies with all applicable rules and Orders under
TSCA, which would include the SNUR requirements should these proposed
rules be finalized. The EPA policy in support of import certification
appears at 40 CFR part 707, subpart B. In addition, pursuant to 40 CFR
721.20 or 40 CFR 725.920 (for the microorganism), any persons who
export or intend to export a chemical substance that is the subject of
this proposed rule on or after July 12, 2021 are subject to the export
notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see
40 CFR 721.20), and must comply with the export notification
requirements in 40 CFR part 707, subpart D.
B. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at https://www.epa.gov/dockets/commenting-epa-dockets.
II. Background
A. What action is the Agency taking?
EPA is proposing these SNURs under TSCA section 5(a)(2) (15 U.S.C.
2604(a)(2)) for chemical substances that were the subject of PMNs and
an MCAN. 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.
[[Page 31240]]
The docket for these proposed SNURs, identified as docket ID number
EPA-HQ-OPPT-2020-0588, 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
and (for microorganisms) 40 CFR part 725, subpart L. These provisions
describe persons subject to the rule, recordkeeping requirements,
exemptions to reporting requirements, and applicability of the rule to
uses occurring before the effective date of the rule. Provisions
relating to user fees appear at 40 CFR part 700. Pursuant to 40 CFR
721.1(c), persons subject to these SNURs must comply with the same
significant new use notice (SNUN) requirements and EPA regulatory
procedures as submitters of PMNs under TSCA section 5(a)(1)(A). These
requirements include the information submission requirements of TSCA
sections 5(b) and 5(d)(1), the exemptions authorized by TSCA sections
5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part
720. Once EPA receives a SNUN and before the manufacture or processing
for the significant new use can commence, EPA must either determine
that the use is not likely to present an unreasonable risk of injury
under the conditions of use for the chemical substance or take such
regulatory action as is associated with an alternative determination.
If EPA determines that the use is not likely to present an unreasonable
risk, EPA is required under TSCA section 5(g) to make public, and
submit for publication in the Federal Register, a statement of EPA's
findings.
III. Significant New Use Determination
TSCA section 5(a)(2) states that EPA's determination that a use of
a chemical substance is a significant new use must be made after
consideration of all relevant factors, including:
The projected volume of manufacturing and processing of a
chemical substance.
The extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical substance.
The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance.
The reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of a
chemical substance.
In determining what would constitute a significant new use for the
chemical substances that are the subject of these SNURs, EPA considered
relevant information about the toxicity of the chemical substances,
potential human exposures and environmental releases that may be
associated with possible uses of these chemical substances, in the
context of the four TSCA section 5(a)(2) factors listed in this unit.
The proposed rules include PMN and MCAN substances that are subject
to Orders issued under TSCA section 5(e)(1)(A), as required by the
determinations made under TSCA section 5(a)(3)(B). The TSCA Orders
require protective measures to limit exposures or otherwise mitigate
the potential unreasonable risk. The proposed SNURs identify
significant new uses as any manufacturing, processing, use,
distribution in commerce, or disposal that does not conform to the
restrictions imposed by the underlying TSCA Orders, consistent with
TSCA section 5(f)(4).
Where EPA determined that the PMN substance may present an
unreasonable risk of injury to human health via inhalation exposure,
the underlying TSCA Order usually requires that potentially exposed
employees wear specified respirators unless actual measurements of the
workplace air show that air-borne concentrations of the PMN substance
are below a New Chemical Exposure Limit (NCEL), and includes
requirements addressing performance criteria for sampling and
analytical methods, periodic monitoring, respiratory protection, and
recordkeeping. No comparable NCEL provisions currently exist in 40 CFR
part 721, subpart B, for SNURs. Therefore, for these cases, the
individual SNURs in 40 CFR part 721, subpart E, will state that persons
subject to the SNUR who wish to pursue NCELs as an alternative to the
40 CFR 721.63 respirator requirements may request to do so under 40 CFR
721.30. EPA expects that persons whose 40 CFR 721.30 requests to use
the NCELs approach for SNURs that are approved by EPA will be required
to comply with NCELs provisions that are comparable to those contained
in the corresponding TSCA Order for the same chemical substance.
IV. Substances Subject to This Proposed Rule
EPA is proposing significant new use and recordkeeping requirements
for certain chemical substances in 40 CFR part 721, subpart E and in 40
CFR part 725, subpart M (for the microorganism). 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 or MCAN number.
Chemical name (generic name, if the specific name is
claimed as CBI).
Chemical Abstracts Service (CAS) Registry number (if
assigned for non-confidential chemical identities).
Effective date of and basis for the TSCA Order.
Potentially Useful Information.
CFR citation assigned in the regulatory text section of
the proposed rule.
The chemicals subject to these proposed SNURs are as follows:
PMN Number: P-16-167
Chemical Name: Hindered amine alkyl ester compounds (generic).
CAS Number: Not available.
Effective Date of TSCA Order: April 24, 2020.
Basis for TSCA Order: The PMN states that the use will be as a
light stabilizer for plastic articles. Based on submitted test data,
EPA has identified concerns for dermal irritation and sensitization.
Based on comparison to analogous aliphatic amines, EPA predicts that
toxicity to aquatic organisms may occur at concentrations that exceed 1
ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient
information to permit a reasoned evaluation, the substance may present
an unreasonable risk of injury to human health or the environment. To
protect against these risks, the Order requires:
Use of personal protective equipment where there is a
potential for dermal exposure;
Use of a National Institute for Occupational Safety and
Health (NIOSH)-certified respirator with an Assigned Protection Factor
(APF) of at least 50 where there is a potential for inhalation
exposure;
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS; and
No release of the PMN substance resulting in surface water
concentrations that exceed 1 ppb.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
[[Page 31241]]
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of chronic
aquatic toxicity and reproduction/developmental toxicity screening
testing may be potentially useful to characterize the human health and
environmental effects of the PMN substance. Although the Order does not
require these tests, the Order's restrictions remain in effect until
the Order is modified or revoked by EPA based on submission of this or
other relevant information.
CFR Citation: 40 CFR 721.11571.
PMN Numbers: P-16-419, P-16-423, and P-16-424
Chemical Names: N-alkyl-dialkyl piperidine (generic) (P-16-419),
Tetraalkylpiperidinium halide (generic) (P-16-423), and
Tetraalkylpiperidinium hydroxide (generic) (P-16-424).
CAS Numbers: Not available.
Effective Date of TSCA Order: April 15, 2020.
Basis for TSCA Order: The PMNs state that the generic (non-
confidential) uses will be as an intermediate (P-16-419 and P-16-423)
and as a directing agent (P-16-424). Based on comparison to analogous
chemical substances, EPA has identified concerns for acute toxicity,
corrosion, systemic and respiratory effects (P-16-419). Based on
comparison to analogous chemical substances and the high pH, EPA has
identified concerns for acute oral toxicity, developmental/reproductive
toxicity, neurotoxicity, renal effects, and corrosion to all tissues
(P-16-423 and P-16-424). Based on comparison to analogous chemical
substances, EPA predicts that toxicity to aquatic organisms may occur
at concentrations that exceed 286 ppb for P-16-419 and 20 ppb for P-16-
423 and P-16-424. 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. The Order was also issued under TSCA sections
5(a)(3)(B)(ii)(II) and 5(e)(1)(A)(ii)(II), based on a finding that the
substance which was the subject of P-16-424 is or will be produced in
substantial quantities and that the substance either enters or may
reasonably be anticipated to enter the environment in substantial
quantities, or there is or may be a significant (or substantial) human
exposure to the substance. To protect against these risks, the Order
requires:
Use of personal protective equipment where there is a
potential for dermal exposure;
Use of a NIOSH-certified respirator with an APF of at
least 10 where there is a potential for inhalation exposure (P-16-419);
Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS;
Use of P-16-419 only as a site-limited intermediate;
Use of P-16-423 only as an intermediate;
Use of P-16-424 only for the confidential use allowed in
the Order; and
No release of the PMN substances resulting in surface
water concentrations that exceed 286 ppb (P-16-419) or 20 ppb (P-16-423
and P-16-424).
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA as determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of aquatic
toxicity and specific target organ toxicity testing may be potentially
useful to characterize the human health and environmental effects of
the PMN substances. Additionally, the results of reproductive toxicity
testing may be potentially useful to characterize the human health
effects of PMNs P-16-423 and P-16-424. Although the Order does not
require these tests, the Order's restrictions remain in effect until
the Order is modified or revoked by EPA based on submission of this or
other relevant information.
CFR Citations: 40 CFR 721.11572 (P-16-419), 40 CFR 721.11573 (P-16-
423), and 40 CFR 721.11574 (P-16-424).
PMN Numbers: P-17-235 and P-18-226
Chemical Names: Amidoamino quaternary ammonium salt (generic) (P-
17-235), and Tri alkyl, mono alkoxy, fatty acid ester, ammonium salt
(generic) (P-18-226).
CAS Numbers: Not available.
Effective Date of TSCA Order: April 22, 2020.
Basis for TSCA Order: The PMNs state that the generic (non-
confidential) use of the PMN substances will be as an anti-agglomerant.
Based on the surfactant properties of the compounds and comparison to
analogous substances, EPA has identified concerns for surfactant
effects on the lungs, irritation and possible corrosion to the eyes,
skin, and respiratory tract. Based on comparison to analogous
substances, EPA has also identified concerns for developmental
toxicity. Based on comparison to analogous polycationic polymers, EPA
predicts that toxicity to aquatic organisms may occur at concentrations
that exceed 60 ppb for P-17-235 and 44 ppb for P-18-226. The Order was
issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I),
based on a finding that in the absence of sufficient information to
permit a reasoned evaluation, the substances may present an
unreasonable risk of injury to human health or the environment. To
protect against these risks, the Order requires:
Use of the PMN substances only for the uses allowed in the
Order; and
No release of the PMN substances resulting in surface
water concentrations that exceed 44 ppb.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of chronic
aquatic toxicity, reproductive toxicity, and pulmonary effects testing
may be potentially useful to characterize the human health and
environmental effects of the PMN substances. Although the Order does
not require these tests, the Order's restrictions remain in effect
until the Order is modified or revoked by EPA based on submission of
this or other relevant information.
CFR Citations: 40 CFR 721.11575 (P-17-235) and 40 CFR 721.11576 (P-
18-226).
PMN Number: P-17-259
Chemical Name: Halogenated aromatic amine (generic).
CAS Number: Not available.
Effective Date of TSCA Order: August 31, 2020.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the substance will be as a curative for
thermosetting resins. Based on comparison to structurally analogous
chemical substances, EPA has identified concerns for skin sensitization
and systemic effects (liver, blood, and spleen). Based on comparison to
[[Page 31242]]
analogous anilines, EPA predicts that toxicity to aquatic organisms may
occur at concentrations that exceed 1 ppb. The Order was issued under
TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a
finding that in the absence of sufficient information to permit a
reasoned evaluation, the substance may present an unreasonable risk of
injury to human health or the environment. To protect against these
risks, the Order requires:
No release of the PMN substance resulting in surface water
concentrations that exceed 1 ppb.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of skin
sensitization, specific target organ toxicity, and aquatic toxicity
testing may be potentially useful to characterize the human health and
environmental effects of the PMN substance. Although the Order does not
require these tests, the Order's restrictions remain in effect until
the Order is modified or revoked by EPA based on submission of this or
other relevant information.
CFR Citation: 40 CFR 721.11577.
PMN Number: P-18-43
Chemical Name: 1,4-Benzenedicarboxylic acid, 1,4-dipentyl ester,
branched and linear.
CAS Number: 2097734-13-7.
Effective Date of TSCA Order: September 16, 2020.
Basis for TSCA Order: The PMN states that the use will be as a
plasticizer or fast fuser in PVC-plastisols for flooring, wall paper,
coated fabrics, underbody coating; processing aid or fast fuser in PVC
dry blends for flooring, coated fabrics, films & sheets, tubes & hoses;
flexibilizing additive for paints and lacquers; use in formulation or
re-packing; and as a laboratory agent. Based on the potential
metabolite terephthalic acid, EPA has identified concerns for systemic
toxicity. Based on comparison to analogous esters, EPA predicts that
toxicity to aquatic organisms may occur at concentrations that exceed 2
ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient
information to permit a reasoned evaluation, the substance may present
an unreasonable risk of injury to human health or the environment. The
Order was also issued under TSCA sections 5(a)(3)(B)(ii)(II) and
5(e)(1)(A)(ii)(II), based on a finding that the substance is expected
to be produced in substantial quantities, and that there may be a
significant or substantial human exposure to the substance, and that
the substance may enter the environment in substantial quantities. To
protect against these risks, the Order requires:
No release of the PMN substance resulting in surface water
concentrations that exceed 2 ppb.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of chronic
aquatic toxicity testing may be potentially useful to characterize the
environmental effects of the PMN substance. Although the Order does not
require these tests, the Order's restrictions remain in effect until
the Order is modified or revoked by EPA based on submission of this or
other relevant information.
CFR Citation: 40 CFR 721.11578.
PMN Numbers: P-18-178, P-18-217, and P-18-218
Chemical Names: Dialkyltin dialkylcarboxylate (generic) (P-18-178),
Alkyltin dodecylthioester (generic) (P-18-217), and Alkyltin
tetradecylthioester (generic) (P-18-218).
CAS Numbers: Not available.
Effective Date of TSCA Order: May 20, 2020.
Basis for TSCA Order: The PMNs state that the use of the substances
will be as stabilizers for PVC compounds. 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 at 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 comparison to
analogous chemical substances, EPA has identified concerns for immune,
reproductive, developmental, and systemic effects. Based on comparison
to analogous organotins, EPA predicts that toxicity to aquatic
organisms may occur at concentrations that exceed 2 ppb. The Order was
issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I),
based on a finding that in the absence of sufficient information to
permit a reasoned evaluation, the substances may present an
unreasonable risk of injury to human health or the environment. The
Order was also issued under TSCA sections 5(a)(3)(B)(ii)(II) and
5(e)(1)(A)(ii)(II), based on a finding that the substances are or will
be produced in substantial quantities and that the substances either
enter or may reasonably be anticipated to enter the environment in
substantial quantities, or there is or may be a significant (or
substantial) human exposure to the substances. To protect against these
risks, the Order requires:
Use of personal protective equipment where there is a
potential for dermal exposure;
Use of a NIOSH-certified respirator with an APF of at
least 10 where there is a potential for inhalation exposure for P-18-
178;
No use of the PMN substances other than as stabilizers for
PVC compounds; and
No release of the PMN substances into the waters of the
United States.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
persistence, bioaccumulation, aquatic toxicity, reproductive toxicity
and specific target organ toxicity testing may be potentially useful to
characterize the human health and environmental effects of the PMN
substances. Although the Order does not require these tests, the
Order's restrictions remain in effect until the Order is modified or
revoked by EPA based on submission of this or other relevant
information.
CFR Citations: 40 CFR 721.11579 (P-18-178), 40 CFR 721.11580 (P-18-
217), and 40 CFR 721.11581 (P-18-218).
PMN Number: P-18-256
Chemical Name: Undecanol, branched.
CAS Number: 203473-00-4.
Effective Date of TSCA Order: August 18, 2020.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a chemical intermediate and
[[Page 31243]]
a solvent. Based on submitted test data on the new chemical substance,
EPA has identified concerns for skin and eye irritation and systemic
toxicity. Based on test data for structurally analogous chemical
substance, EPA has also identified concerns for developmental and
systemic toxicity. Based on comparison to analogous neutral organics,
EPA predicts that toxicity to aquatic organisms may occur at
concentrations that exceed 4 ppb. The Order was issued under TSCA
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding
that in the absence of sufficient information to permit a reasoned
evaluation, the substance may present an unreasonable risk of injury to
human health or the environment. The Order was also issued under TSCA
sections 5(a)(3)(B)(ii)(II) and 5(e)(1)(A)(ii)(II), based on a finding
that the substance is expected to be produced in substantial
quantities, and that there may be significant or substantial human
exposure to the substance, and that the substance may enter the
environment in substantial quantities. To protect against these risks,
the Order requires:
No use of the PMN substance other than as a chemical
intermediate; and
No release of the PMN substance resulting in surface water
concentrations that exceed 4 ppb.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
specific organ toxicity, developmental toxicity, and aquatic toxicity
testing may be potentially useful to characterize the human health and
environmental effects of the PMN substance. Although the Order does not
require these tests, the Order's restrictions remain in effect until
the Order is modified or revoked by EPA based on submission of this or
other relevant information.
CFR Citation: 40 CFR 721.11582.
PMN Number: P-18-283
Chemical Name: Hydroxy alkanoic acid, compds. with
aminoalkoxyalcohol-epoxy polymer-alkanolamine reaction products
(generic).
CAS Number: Not available.
Effective Date of TSCA Order: March 31, 2020.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the substance will be for open, non-dispersive
use. Based on comparison to structurally analogous chemical substances
for the low molecular weight (LMW) fractions of the PMN substance, EPA
has identified concerns for irritation and sensitization. Based on
comparison to structurally analogous chemical substances, EPA has also
identified concerns for reproductive toxicity and systemic effects.
Based on comparison to analogous aliphatic amines and polycationic
polymers, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 4 ppb. The Order was issued under TSCA
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding
that in the absence of sufficient information to permit a reasoned
evaluation, the substance may present an unreasonable risk of injury to
human health and the environment. To protect against these risks, the
Order requires:
Use of personal protective equipment where there is a
potential for dermal exposure;
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS; and
No release of the PMN substance into the waters of the
United States.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of aquatic
toxicity, skin and eye irritation, skin sensitization, reproductive
toxicity, and specific target organ toxicity testing may be potentially
useful to characterize the human health and environmental effects of
the PMN substance. Although the Order does not require these tests, the
Order's restrictions remain in effect until the Order is modified or
revoked by EPA based on a submission of this or other relevant
information.
CFR Citation: 40 CFR 721.11583.
PMN Number: P-18-298
Chemical Name: 1,3-Propanediol, 2-ethyl-2-(hydroxymethyl)-, polymer
with ethyleneamine, 2-(chloromethyl)oxirane, 2-[[4-(1,1-
dimethylethyl)phenoxy]methyl]oxirane, 2,2'-[1,6-
hexanediylbis(oxymethylene)]bis[oxirane], 4,4'-(1-
methylethylidene)bis[phenol], alkyl ether amine, and 2-[(2-
methylphenoxymethyl]oxirane (generic).
CAS Number: Not available.
Effective Date of TSCA Order: August 4, 2020.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as an epoxy curing agent. Based on comparison
to structurally analogous amines and the LMW fractions, EPA has
identified concerns for skin and eye irritation, dermal and respiratory
sensitization, and lung effects. Based on the comparison to
structurally analogous epoxide residuals, EPA has also identified
concerns for reproductive toxicity and systemic effects. Based on
comparison to analogous aliphatic amines and polycationic polymers, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 50 ppb. The Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the
absence of sufficient information to permit a reasoned evaluation, the
substance may present an unreasonable risk of injury to human health or
the environment. To protect against these risks, the Order requires:
No manufacturing, processing, or use of the PMN substance
in an application method that results in inhalation exposure;
No use of the PMN substance in a consumer product; and
No release of the PMN substance resulting in surface water
concentrations that exceed 50 ppb.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
absorption, eye damage, skin irritation, specific target organ
toxicity, and aquatic toxicity testing may be potentially useful to
characterize the human health and environmental effects of the PMN
substance. Although the Order does not require these tests, the Order's
restrictions remain in effect until the Order is modified or revoked by
EPA based on submission of this or other relevant information.
CFR Citation: 40 CFR 721.11584.
PMN Number: P-18-310
Chemical Name: Benzenepropanoic acid, 3-(2H-benzotriazol-2-yl)-5-
(1,1-
[[Page 31244]]
dimethylethyl)-4-hydroxy-2,2-bis(hydroxymethyl)butyl ester.
CAS Number: 2101609-93-0.
Effective Date of TSCA Order: August 14, 2020.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a polymer additive. Based on test data on
structurally analogous chemical substances, EPA has identified concerns
for blood, liver, thyroid and kidney effects, reproductive toxicity,
and developmental toxicity. Based on comparison to analogous phenols
and benzotriazoles, EPA predicts toxicity to aquatic organisms may
occur at concentrations that exceed 1 ppb. The Order was issued under
TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a
finding that in the absence of sufficient information to permit a
reasoned evaluation, the substance may present an unreasonable risk of
injury to human health or the environment. To protect against these
risks, the Order requires:
Use of personal protective equipment where there is a
potential for dermal exposure;
Use of a NIOSH-certified respirator with an APF of at
least 1,000 where there is a potential for inhalation exposure;
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS; and
No release of the PMN substance resulting in surface water
concentrations that exceed 1 ppb.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if the manufacturer or processor
is considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
developmental neurotoxicity and aquatic toxicity testing may be
potentially useful to characterize the human health and environmental
effects of the PMN substance. Although the Order does not require these
tests, the Order's restrictions remain in effect until the Order is
modified or revoked by EPA based on submission of this or other
relevant information.
CFR Citation: 40 CFR 721.11585.
PMN Number: P-18-318
Chemical Name: 1-Octadecanaminium, N,N-dimethyl-N- [3-
(triethoxysilyl)propyl]-, chloride (1:1).
CAS Number: 62117-57-1.
Effective Date of TSCA Order: September 25, 2020.
Basis for TSCA Order: The PMN states that the use will be as a
surface treatment for added lubricity and anti-static purposes. Based
on comparison to structurally analogous chemical substances, EPA has
identified concerns for irritation to the eyes, skin, and respiratory
tract and liver effects. Based on comparison to structurally analogous
chemical substances and structural alerts for cationic surfactants, EPA
has also identified concerns for lung effects. Based on comparison to
analogous polycationic polymers, EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 1 ppb. The Order was
issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I),
based on a finding that in the absence of sufficient information to
permit a reasoned evaluation, the substance may present an unreasonable
risk of injury to human health or the environment. To protect against
these risks, the Order requires:
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS;
Use of the PMN substance only as a surface treatment for
added lubricity and anti-static properties;
No use of the PMN substance in an application method that
results in inhalation exposure; and
No release of the PMN substance resulting in surface water
concentrations that exceed 1 ppb.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of skin
irritation, eye irritation, pulmonary effects, and aquatic toxicity
testing may be potentially useful to characterize the human health and
environmental effects of the PMN substance. Although the Order does not
require these tests, the Order's restrictions remain in effect until
the Order is modified or revoked by EPA based on submission of this or
other relevant information.
CFR Citation: 40 CFR 721.11586.
PMN Number: P-18-323
Chemical Name: 2-Propenoic acid, 2-methyl-, 3-methyl-3-buten-1-yl
ester.
CAS Number: 156291-88-2.
Effective Date of TSCA Order: March 13, 2020.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the PMN substance will be as a raw material for
polymer manufacturing. Based on submitted test data on the PMN
substance and structural alerts, EPA has identified concerns for skin
irritation and skin/respiratory sensitization. Based on comparison to
structurally analogous chemical substances, EPA has also identified
concerns for systemic, respiratory, and developmental effects. Based on
comparison to analogous methacrylates, EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 98 ppb. The Order was
issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I),
based on a finding that in the absence of sufficient information to
permit a reasoned evaluation, the substance may present an unreasonable
risk of injury to human health or the environment. To protect against
these risks, the Order requires:
Use of personal protective equipment where there is a
potential for dermal exposure;
Use of a NIOSH-certified respirator with an APF of at
least 50 to prevent inhalation exposure where there is a potential for
inhalation exposure;
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS;
Use of the PMN substance only for the confidential use
allowed in the Order; and
No release of the PMN substance resulting in surface water
concentrations that exceed 98 ppb.
The proposed SNUR designates as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that would be
designated by this SNUR. EPA has determined that the results of chronic
aquatic toxicity and specific target organ toxicity testing may be
potentially useful to characterize the environmental and human health
effects of the PMN substance. Although the Order does not require these
tests, the Order's restrictions remain in effect until the Order is
modified or revoked by EPA based on submission of this or other
relevant information.
CFR Citation: 40 CFR 721.11587.
[[Page 31245]]
PMN Number: P-18-327
Chemical Name: Mixed metal oxide (generic).
CAS Number: Not available.
Effective Date of TSCA Order: August 21, 2020.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a filler for non-dispersive resins. Based
on comparison to structurally analogous chemical substances, EPA has
identified concerns for dermal and respiratory sensitization. EPA has
also identified concerns for lung effects (lung overload) if the
particulate is respirable, based on information for other poorly
soluble particulates, and carcinogenicity if the PMN substance is
crystalline and respirable. The Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the
absence of sufficient information to permit a reasoned evaluation, the
substance may present an unreasonable risk of injury to human health or
the environment. To protect against these risks, the Order requires:
Use of personal protective equipment where there is a
potential for dermal exposure;
Use of a NIOSH-certified respirator with an APF of at
least 1,000 where there is a potential for inhalation exposure, or
compliance with a NCEL of 0.1 mg/m\3\ as an 8-hour time-weighted
average (TWA) to prevent inhalation exposure; and
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
pulmonary toxicity, skin sensitization, and carcinogenicity testing may
be potentially useful to characterize the human health effects of the
PMN substance. Although the Order does not require these tests, the
Order's restrictions remain in effect until the Order is modified or
revoked by EPA based on submission of this or other relevant
information.
CFR Citation: 40 CFR 721.11588.
PMN Number: P-18-347
Chemical Name: Amines, polyethylenepoly-, triethylenetetramine
fraction, polymers with guanidine hydrochloride (1:1).
CAS Number: 1902936-67-7.
Effective Date of TSCA Order: March 17, 2020.
Basis for TSCA Order: The PMN states that the use of the substance
will be as an aldehyde scavenger for the manufacture of polyurethane
foams. Based on comparison to structurally analogous chemical
substances, EPA has identified concerns for skin sensitization. Based
on available test data on the PMN substance, EPA has also identified
concerns for acute toxicity. Based on structural alerts for
polycationic binding, EPA has also identified concerns for lung
effects. Based on comparison to structurally analogous polycationic
polymers, EPA predicts that toxicity to aquatic organisms may occur at
concentrations that exceed 2 ppb. The Order was issued under TSCA
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding
that in the absence of sufficient information to permit a reasoned
evaluation, the substance may present an unreasonable risk of injury to
human health and the environment. To protect against these risks, the
Order requires:
Use of personal protective equipment where there is a
potential for dermal exposure;
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS; and
No release of the PMN substance resulting in surface water
concentrations that exceed 2 ppb.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information about may be potentially useful in support of a request by
the PMN submitter to modify the Order, or if a manufacturer or
processor is considering submitting a SNUN for a significant new use
that would be designated by this SNUR. EPA has determined that the
results of aquatic toxicity, pulmonary effects and skin sensitization
testing may be potentially useful to characterize the human health and
environmental effects of the PMN substance. Although the Order does not
require these tests, the Order's restrictions remain in effect until
the Order is modified or revoked by EPA based on submission of this or
other relevant information.
CFR Citation: 40 CFR 721.11589.
PMN Number: P-18-405
Chemical Name: Phenol, 4,4'-(1-methylethylidene)bis-, polymer with
3,6,9,12-tetraoxatetradeca-1, 13-diene, glycidyl ether.
CAS Number: 647028-24-8.
Effective Date of TSCA Order: August 7, 2020.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as an adhesive. Based on the epoxide moiety
for the LMW fraction, EPA has identified concerns for skin and lung
sensitization, carcinogenicity, developmental toxicity, male
reproductive toxicity, liver, and kidney toxicity. Based on submitted
test data, information in the SDS, and analogous epoxides, EPA has also
identified concerns for skin irritation and genotoxicity. Based on
comparison to analogous epoxides, EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 1 ppb. The Order was
issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I),
based on a finding that in the absence of sufficient information to
permit a reasoned evaluation, the substance may present an unreasonable
risk of injury to human health or the environment. To protect against
such risks, the Order requires:
No manufacturing, processing, or use of the PMN substance
in a manner that results in inhalation exposure;
No use of the PMN substance in a consumer product; and
No release of the PMN substance resulting in surface water
concentrations that exceed 1 ppb.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
pulmonary toxicity, skin sensitization, carcinogenicity, reproductive/
developmental toxicity, skin and eye irritation, specific target organ
toxicity and aquatic toxicity testing may be potentially useful to
characterize the human health and environmental effects of the PMN
substance. Although the Order does not require these tests, the Order's
restrictions remain in effect until the Order is modified or revoked by
EPA based on submission of this or other relevant information.
CFR Citation: 40 CFR 721.11590.
PMN Number: P-19-36
Chemical Name: 1,4-Benzenedicarboxylic acid, 1,4-bis(2-
phenoxyethyl) ester.
[[Page 31246]]
CAS Number: 25900-07-6.
Effective Date of TSCA Order: July 24, 2020.
Basis for TSCA Order: The PMN states that the use will be as an
additive to polymers for improvement in gas barrier performance. Based
on comparison to structurally analogous chemical substances, EPA has
identified concerns for irritation to the skin, eyes, and respiratory
tract. Based on test data for terephthalic acid, EPA has also
identified concerns for bladder effects and developmental effects.
Based on test data for 2-phenoxyethanol, EPA has also identified
concerns for blood effects, kidney effects, bladder effects, and
respiratory tract effects. Based on comparison to analogous esters, EPA
predicts that toxicity to aquatic organisms may occur at concentrations
that exceed 3 ppb. The Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the
absence of sufficient information to permit a reasoned evaluation, the
substance may present an unreasonable risk of injury to human health or
the environment. To protect against these risks, the Order requires:
Use of personal protective equipment where there is a
potential for dermal exposure;
Use of a NIOSH-certified respirator with an APF of at
least 1,000 where there is a potential for inhalation exposure; and
No release of the PMN substance resulting in surface water
concentrations that exceed 3 ppb.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of skin
irritation, reproductive/developmental toxicity, specific target organ
toxicity, and aquatic toxicity testing may be potentially useful to
characterize the human health and environmental effects of the PMN
substance. Although the Order does not require these tests, the Order's
restrictions remain in effect until the Order is modified or revoked by
EPA based on submission of this or other relevant information.
CFR Citation: 40 CFR 721.11591.
PMN Number: P-19-52
Chemical Name: Poly(oxy-1,2-ethanediyl), .alpha.-nonyl-.omega.-
hydroxy-, branched and linear.
CAS Number: 2242406-13-7.
Effective Date of TSCA Order: February 14, 2020.
Basis for TSCA Order: The PMN states that the use of the PMN
substance will be as a hard surface cleaner and as a component of
laundry detergent. Based on repeating polyether units, EPA has
identified concerns for surfactant effects on the lungs. Based on
comparison to structurally analogous chemical substances, EPA has also
identified concerns for eye corrosion and mild skin irritation. Based
on alcohol ethoxylates, EPA has also identified liver, cardiac, and
systemic effects. Based on comparison to analogous nonionic
surfactants, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 34 ppb. The Order was issued under TSCA
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding
that in the absence of sufficient information to permit a reasoned
evaluation, the substance may present an unreasonable risk of injury to
human health or the environment. To protect against these risks, the
Order requires:
Use of personal protective equipment where there is a
potential for dermal exposure;
Use of a NIOSH-certified respirator with an APF of at
least 1,000 where there is potential for inhalation exposure;
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS;
No use of the PMN substance where the concentration of the
PMN substance in the product formulation intended for distribution in
commerce exceeds 1% by weight; and
No release of the PMN substance resulting in surface water
concentrations that exceed 34 ppb.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of acute
aquatic toxicity, chronic aquatic toxicity, pulmonary effects, specific
target organ toxicity, eye damage, and skin irritation testing may be
potentially useful to characterize the human health and environmental
effects of the PMN substance. Although the Order does not require these
tests, the Order's restrictions still remain in effect until the Order
is modified or revoked by EPA based on submission of this or other
relevant information.
CFR Citation: 40 CFR 721.11592.
PMN Number: P-19-53
Chemical Name: 1-Butanamine, N-butyl-N-[(triethoxysilyl)methyl]-.
CAS Number: 35501-23-6.
Effective Date of TSCA Order: August 5, 2020.
Basis for TSCA Order: The PMN states that the use of the substance
will be as a surface treatment, sealant, caulk, and coating for mineral
building materials such as concrete, brick, limestone, and plaster, as
well as on wood, metal, and other substrates. Based on the
alkoxysilanes category and reactivity of the new chemical substance,
EPA has identified concerns for lung effects. Based on submitted test
data, EPA has also identified concerns for skin sensitization and
developmental effects. Based on comparison to analogous aliphatic
amines, EPA predicts toxicity to aquatic organisms may occur in
concentrations that exceed 150 ppb. The Order was issued under TSCA
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding
that in the absence of sufficient information to permit a reasoned
evaluation, the substance may present an unreasonable risk of injury to
human health or the environment. To protect against these risks, the
Order requires:
Use of dermal protective equipment where there is a
potential for dermal exposure;
No import, processing, or use of the PMN substance other
than in liquid form;
No domestic manufacture (i.e., import only); and
No use of the PMN substance in a consumer product.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
pulmonary effects and skin sensitization testing may be potentially
useful to characterize the human health effects of the PMN substance.
Although the Order does not require these tests, the Order's
restrictions remain in effect until the Order is modified or revoked by
EPA based on submission of this or other relevant information.
CFR Citation: 40 CFR 721.11593.
[[Page 31247]]
PMN Number: P-19-77
Chemical Name: Alkenylamide (generic).
CAS Number: Not available.
Effective Date of TSCA Order: March 31, 2020.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the substance will be for agricultural use. Based
on available test data on a structurally analogous chemical substance,
EPA has identified concerns for skin irritation, eye irritation,
reproductive toxicity, and systemic toxicity. Based on information in
the SDS, EPA has also identified concerns for respiratory tract
irritation. Based on comparison to analogous amides, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed 4
ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)I), based on a finding that in the absence of sufficient
information to permit a reasoned evaluation, the substance may present
an unreasonable risk of injury to human health and the environment. To
protect against these risks, the Order requires:
Use of the PMN substance only for the confidential use
allowed in the Order; and
No release of the PMN substance resulting in surface water
concentrations that exceed 4 ppb.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that would be
designated by this SNUR. EPA has determined that the results of eye
damage, skin irritation, specific target organ toxicity, and aquatic
toxicity testing may be potentially useful to characterize the human
health and environmental effects of the PMN substance. Although the
Order does not require these tests, the Order's restrictions remain in
effect until the Order is modified or revoked by EPA based on
submission of this or other relevant information.
CFR Citation: 40 CFR 721.11594.
PMN Number: P-19-131
Chemical Name: Isoalkylaminium, N-isoalkyl, -N, N-dimethyl chloride
(generic).
CAS Number: Not available.
Effective Date of TSCA Order: July 24, 2020.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as an additive for horizontal oil drilling.
Based on comparison to structurally analogous chemical substances, EPA
has identified concerns for irritation to the eyes and skin, systemic
effects, lung effects, and developmental effects. Based on comparison
to analogous chemical substances, EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 1 ppb. The Order was
issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I),
based on a finding that in the absence of sufficient information to
permit a reasoned evaluation, the substance may present an unreasonable
risk of injury to human health or the environment. To protect against
these risks, the Order requires:
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS;
No manufacturing, processing, or use of the PMN substance
in a manner that results in inhalation exposure;
No use of the PMN substance in consumer products; and
No release of the PMN substance resulting in surface water
concentrations that exceed 1 ppb.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of skin
irritation, eye irritation, specific target organ toxicity, and aquatic
toxicity testing may be potentially useful to characterize the human
health and environmental effects of the PMN substance. Although the
Order does not require these tests, the Order's restrictions remain in
effect until the Order is modified or revoked by EPA based on
submission of this or other relevant information.
CFR Citation: 40 CFR 721.11595.
PMN Numbers: P-19-143 and P-19-144
Chemical Names: Aldehyde, polymer with mixed alkane polyamines,
2,2'-[1,4-alkanediylbis(oxyalkylene)]bis[oxirane], 2-
(alkoxyalkyloxirane, 4,4'-(1-alkylidene)bis[phenol], 2,2'-[(1-
alkylidene)bis(4,1-alkyleneoxyalkylene)]bis[oxirane] and 2-
(aryloxyalkyl)oxirane, acetate (salt) (generic) (P-19-143) and
Alkanedioic acid, compds. with substituted arylalkylamine-arylalcohol
disubstituted alkane-the diglycidyl ether of a arylalcohol
disubstituted alkane-epichlorohydrin-aldehyde-2,2'[(1-
alkylidene)bis[4,1-aryleneoxy(alkyl-2,1-
alkanediyl)oxyalkylene]]bis[oxirane]-alkanepolyamine polymer-1-[[2-[(2-
aminoalkyl)amino]alkyl]amino]-3-aryloxy-2-alcohol reaction products
(generic) (P-19-144).
CAS Numbers: Not available.
Effective Date of TSCA Order: February 18, 2020.
Basis for TSCA Order: The PMNs state that the use of the substances
will be as a crosslinking agent for use in epoxy resin for water-based
coating for a variety of substrates and civil applications in
commercial uses (P-19-143) and a crosslinking agent in epoxy based
self-leveling floor coatings (P-19-144). EPA has identified concerns
for lung effects (cationic binding) if respirable particles are
inhaled. Based on structural alerts for polyamines, EPA has identified
dermal and respiratory sensitization. Based on comparison to analogous
chemical substances, EPA has identified concerns for skin and eye
irritation. Based on the LMW species, EPA has also identified concerns
for systemic, reproductive, and developmental effects. Based on
comparison to analogous polycationic polymers, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 1 ppb. The
Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient
information to permit a reasoned evaluation, the substances may present
an unreasonable risk of injury to human health or the environment. The
Order was also issued under TSCA sections 5(a)(3)(B)(ii)(II) and
5(e)(1)(A)(ii)(II), based on a finding that the substance which was the
subject of PMN P-19-143 is expected to be produced in substantial
quantities, and that there may be significant or substantial human
exposure to the substance, and that the substance may enter the
environment in substantial quantities. To protect against these risks,
the Order requires:
No manufacture, processing, or use of the PMN substances
in a manner that results in inhalation exposure to either the PMN
substances or to formaldehyde;
No use of the PMN substances in consumer products; and
No release of the PMN substances resulting in surface
water concentrations that exceed 1 ppb.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
[[Page 31248]]
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
pulmonary effects, eye irritation, skin irritation, skin sensitization,
specific target organ toxicity, reproductive and developmental
toxicity, and aquatic toxicity testing may be potentially useful to
characterize the human health and environmental effects of the PMN
substances. Although the Order does not require these tests, the
Order's restrictions remain in effect until the Order is modified or
revoked by EPA based on submission of this or other relevant
information.
CFR Citations: 40 CFR 721.11596 (P-19-143) and 40 CFR 721.11597 (P-
19-144).
PMN Number: P-19-145
Chemical Name: Polyazaalkane with oxirane and methyloxirane,
haloalkane (generic).
CAS Number: Not available.
Effective Date of TSCA Order: July 6, 2020.
Basis for TSCA Order: The PMN states that the use of the substance
will be as an oil field drilling fluid additive. Based on structure,
EPA has identified concerns for lung effects (surfactancy). Based on
comparison to structurally analogous chemical substances, EPA has also
identified concerns for neurological, systemic, and reproductive/
developmental effects. Based on comparison to analogous cationic
polymers, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 26 ppb. The Order was issued under TSCA
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding
that in the absence of sufficient information to permit a reasoned
evaluation, the substance may present an unreasonable risk of injury to
human health or the environment. To protect against these risks, the
Order requires:
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS;
No manufacture, processing, or use of the PMN substance in
a manner that results in inhalation exposure; and
No release of the PMN substance resulting in surface water
concentrations that exceed 26 ppb.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
neurotoxicity, specific target organ toxicity, pulmonary effects,
reproductive/developmental effects, and aquatic toxicity testing may be
potentially useful to characterize the health and environmental effects
of the PMN substance. Although the Order does not require these tests,
the Order's restrictions remain in effect until the Order is modified
or revoked by EPA based on submission of this or other relevant
information.
CFR Citation: 40 CFR 721.11598.
PMN Number: P-19-153
Chemical Name: Dibromoalkyl ether tetrabromobisphenol A (generic).
CAS Number: None available.
Effective Date of TSCA Order: July 20, 2020.
Basis for TSCA Order: The PMN states that the use of the substance
will be as a raw material in flame retardant products. Based on the
physical/chemical properties of the PMN substance and of the photolysis
product, the PMN substance and the photolysis product are potentially
persistent, bioaccumulative, and toxic (PBT) chemicals (as described in
the New Chemical Program's PBT category at 64 FR 60194; November 4,
1999; FRL-6097-7). EPA estimates that the PMN substance will persist in
the environment for more than 6 months and estimates a bioaccumulation
factor of greater than or equal to 1,000. EPA estimates that the
photolysis product 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 available data on the PMN substance, EPA has
identified concerns for eye irritation, systemic effects, and
reproductive/developmental effects. Based on data for the photolysis
product, EPA has also identified concerns for systemic effects and
carcinogenicity. Based on comparison to analogous anionic surfactants,
EPA predicts toxicity to aquatic organisms may occur at concentrations
that exceed 1 ppb. The Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the
absence of sufficient information to permit a reasoned evaluation, the
substance may present an unreasonable risk of injury to human health or
the environment. To protect against these risks, the Order requires:
Use of personal protective equipment where there is a
potential for dermal exposure;
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS; and
No release of the PMN substance into surface waters of the
United States.
The proposed SNUR would designate as a ``significant new use'' in
the absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
environmental fate, bioaccumulation, specific target organ toxicity and
carcinogenicity testing may be potentially useful to characterize the
human health effects of the PMN substance. Although the Order does not
require these tests, the Order's restrictions remain in effect until
the Order is modified or revoked by EPA based on submission of this or
other relevant information.
CFR Citation: 40 CFR 721.11599.
PMN Number: P-20-29
Chemical Name: Octonal, 7(or 8)-formyl-.
CAS Number: 1607842-40-9.
Effective Date of TSCA Order: August 5, 2020.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as an oil soluble additive. Based on
submitted test data on the new chemical substance, EPA has identified
concerns for skin and eye irritation, dermal sensitization, systemic
toxicity, and neurotoxicity. Based on OECD Toolbox results, EPA has
identified concerns for respiratory sensitization. Based on comparison
to structurally analogous chemical substances, EPA has also identified
concerns for respiratory effects. Based on comparison to analogous
neutral organics, EPA predicts toxicity to aquatic organisms may occur
at concentrations that exceed 17 ppb. The Order was issued under TSCA
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding
that in the absence of sufficient information to permit a reasoned
evaluation, the substance may present an unreasonable risk of injury to
human health or the environment. To protect against these risks, the
Order requires:
[[Page 31249]]
No release of the PMN substance resulting in surface water
concentrations that exceed 17 ppb.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of aquatic
toxicity testing may be potentially useful to characterize the
environmental effects of the PMN substance. Although the Order does not
require these tests, the Order's restrictions remain in effect until
the Order is modified or revoked by EPA based on submission of this or
other relevant information.
CFR Citation: 40 CFR 721.115600.
PMN Number: P-20-42
Chemical Name: Sulfonium, trisaryl-, 7,7-dialkyl-2-
heteropolycyclic-1-alkanesulfonate (1:1) (generic).
CAS Number: Not available.
Effective Date of TSCA Order: April 29, 2020.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the PMN substance will be as a photoacid
generator. 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 at
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 the photoreactivity of the PMN substance, EPA has identified
concerns for photosensitization. Based on comparison to analogous
substances, EPA has identified concerns for eye corrosion, irritation,
acute toxicity, liver toxicity, neurotoxicity, and reproductive
(developmental) toxicity. EPA has also identified concerns for lung
overload by insoluble polymers for photoacid generators with polymeric
anions that have a molecular weight over 10,000 g/mol. The Order was
issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I),
based on a finding that in the absence of sufficient information to
permit a reasoned evaluation, the substance may present an unreasonable
risk of injury to human health or the environment. To protect against
these risks, the Order requires:
No manufacture of the PMN substance beyond the time limits
specified in the Order without submittal to EPA the results of certain
testing described in the Testing section of the Order.
Use of personal protective equipment where there is a
potential for dermal exposure;
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS;
No modification of the processing of the PMN substance in
any way that generates a vapor, dust, mist, or aerosol in a non-
enclosed process;
Use of the PMN substance only as described in the PMN;
No domestic manufacture of the PMN substance (i.e., import
only);
Import of the PMN substance only in solution, or in any
form in sealed containers weighing 5 kilograms or less; and
No exceedance of the confidential annual importation
volume listed the Order.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information about the physical/chemical properties, fate,
bioaccumulation, environmental hazard, and human health effects of the
PMN substance may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. The submitter has agreed not to exceed the
time limits specified in the Order without performing the required Tier
I and Tier II testing outlined in the Testing section of the Order.
CFR Citation: 40 CFR 721.11601.
PMN Number: P-20-104
Chemical Name: Alkenoic acid, polymer with (alkyl alkenyl)
polyether (generic).
CAS Number: None available.
Effective Date of TSCA Order: August 25, 2020.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as an additive. Based on structural alerts
and comparison to structurally analogous chemical substances, EPA has
identified concerns for lung effects (surfactancy) and irritation to
the skin, eyes, and respiratory tract. Based on comparison to
structurally analogous chemical substances, EPA has also identified
concerns for systemic effects (i.e., neurotoxicity and cardiotoxicity)
and aquatic toxicity. Based on a residual which is present in the
substance, EPA has also identified concerns for irritation/corrosion to
the skin and eyes, skin sensitization, systemic effects, and
developmental effects. The Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the
absence of sufficient information to permit a reasoned evaluation, the
substance may present an unreasonable risk of injury to human health.
The Order was also issued under TSCA sections 5(a)(3)(B)(ii)(II) and
5(e)(1)(A)(ii)(II), based on a finding that the substance is expected
to be produced in substantial quantities, and that there may be
significant or substantial human exposure to the substance, and that
the substance may enter the environment in substantial quantities. To
protect against these risks, the Order requires:
No manufacture, processing, or use of the PMN substance in
a manner that results in inhalation exposure;
No use of the PMN substance in a consumer product;
No release of the PMN substance resulting in surface water
concentrations that exceed 75 ppb.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of aquatic
toxicity testing may be potentially useful to characterize the
environmental effects of the PMN substance. Although the Order does not
require these tests, the Order's restrictions remain in effect until
the Order is modified or revoked by EPA based on submission of this or
other relevant information.
CFR Citation: 40 CFR 721.11602.
MCAN Number: J-16-26
Microorganism name: Trichoderma reesei modified (generic).
CAS number: Not applicable.
Effective Date of TSCA Order: April 10, 2017.
Basis for TSCA Order: The MCAN states that the generic (non-
confidential) use of the microorganism will be for enzyme production.
EPA determined that certain fermentation conditions, other than the
typical submerged standard industrial fermentation process
[[Page 31250]]
for enzyme production, could result in increased exposures.
Specifically, EPA is concerned that where growth on plant material or
on solid substrates occurs, T. reesei has been shown to produce a
secondary metabolite known as paracelsin, which is associated with a
variety of toxic effects to mammalian and bacterial cells. 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 microorganism may present an
unreasonable risk of injury to human health or the environment. To
protect against these risks, the Order requires:
No manufacture, processing, or use of the microorganism
other than in a fermentation system that meets all of the following
conditions:
(A) Enzyme production occurs by submerged fermentation (i.e., for
enzyme production, growth of the microorganism occurs beneath the
surface of the liquid growth medium); and
(B) Any fermentation of solid plant material or insoluble
substrate, to which Trichoderma reesei fermentation broth is added
after the standard industrial fermentation is completed, is initiated
only after the inactivation of the microorganism as delineated in 40
CFR 725.422(d).
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that the results
of the following studies would help characterize any potential human
health and environmental effects of the MCAN substance if a
manufacturer or processor is considering submitting a SNUN for a
significant new use that would be designated by this SNUR:
Investigation of whether paracelsin will be produced, and
at what levels if the genetically-modified T. reesei is grown on
various plant biomass materials for different durations under various
fermentation conditions in cellulosic biomass facilities.
If paracelsin is produced, a study of whether paracelsin
would be denatured/inactivated during production and processing.
If paracelsin is released from the facility, a study of
whether paracelsin would be degraded/inactivated during wastewater
treatment.
If released to the environment, studies on the
persistence, stability, dissemination, accumulation, and the potential
resulting biological activity of paracelsin with exposure to aquatic
and terrestrial organisms in the environment.
Studies to determine the ability of the MCAN microorganism
to survive in the environment relative to the survival of the
unmodified parent or recipient strain, and to assess its
competitiveness with other fungi in the environment. This study may
require some supplementation with one or more carbon sources and the
use of various soil types.
A study to determine survival of the fungus during an
anaerobic fermentation for production of ethanol by an ethanologen, and
survival of the fungus during ethanol distillation or at the
distillation temperature for ethanol.
Although the Order does not require these tests, the Order's
restrictions remain in effect until the Order is modified or revoked by
EPA based on submission of this or other relevant information.
CFR citation: 40 CFR 725.1081.
V. Rationale and Objectives of the Proposed Rule
A. Rationale
During review of the PMNs and MCAN submitted for the chemical
substances that are the subject to these proposed SNURs, EPA concluded
that regulation was warranted under TSCA section 5(e), pending the
development of information sufficient to make reasoned evaluations of
the health or environmental effects of the chemical substances. The
basis for such findings is outlined in Unit IV. Based on these
findings, TSCA section 5(e) Orders requiring the use of appropriate
exposure controls were negotiated with the PMN and MCAN submitters. As
a general matter, EPA believes it is necessary to follow the TSCA
Orders with a SNUR that identifies the absence of those protective
measures as significant new uses to ensure that all manufacturers and
processors--not just the original submitter--are held to the same
standard.
B. Objectives
EPA is proposing these SNURs for specific chemical substances which
have undergone premanufacture review because the Agency wants:
To identify as significant new uses any manufacturing,
processing, use, distribution in commerce, or disposal that does not
conform to the restrictions imposed by the underlying TSCA Orders,
consistent with TSCA section 5(f)(4).
To have an opportunity to review and evaluate data
submitted in a SNUN before the notice submitter begins manufacturing or
processing a listed chemical substance for the described significant
new use.
To be able to either determine that the prospective
manufacture or processing is not likely to present an unreasonable
risk, or to take necessary regulatory action associated with any other
determination, before the described significant new use of the chemical
substance occurs.
VI. Applicability of the Proposed Significant New Use Designation
To establish a significant new use, EPA must determine that the use
is not ongoing. The chemical substances subject to this proposed rule
have undergone premanufacture review. In cases where EPA has not
received a 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 (or MCAN, as applicable).
Therefore, for chemical substances for which an NOC has not been
submitted EPA concludes that the designated significant new uses are
not ongoing.
When chemical substances identified in this proposed rule are added
to the TSCA Inventory, EPA recognizes that, before the rule is
effective, other persons might engage in a use that has been identified
as a significant new use. However, TSCA Orders have been issued for
these chemical substances and the PMN and MCAN submitters are
prohibited by the TSCA Orders from undertaking activities which would
be designated as significant new uses. The identities of many of the
chemical substances subject to this proposed rule have been claimed as
confidential per 40 CFR 720.85 or 40 CFR 725.85 (for the
microorganism). 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 June 11, 2021 as the cutoff date for
determining whether the new use is ongoing. The objective of EPA's
approach is to ensure that a person cannot defeat a SNUR by initiating
a significant new use before the effective date of the final rule.
In the unlikely event that a person began commercial manufacture or
processing of the chemical substances for a significant new use
identified as of 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
[[Page 31251]]
notice, made an appropriate determination on the notice, and has taken
such actions as are required with that determination.
Issuance of a SNUR for a chemical substance does not signify that
the chemical substance is listed on the TSCA Chemical Substance
Inventory (TSCA Inventory). Guidance on how to determine if a chemical
substance is on the TSCA Inventory is available on the internet at
https://www.epa.gov/tsca-inventory.
VII. Development and Submission of Information
EPA recognizes that TSCA section 5 does not require developing any
particular new information (e.g., generating test data) before
submission of a SNUN. There is an exception: If a person is required to
submit information for a chemical substance pursuant to a rule, TSCA
Order or consent agreement under TSCA section 4, then TSCA section
5(b)(1)(A) requires such information to be submitted to EPA at the time
of submission of the SNUN.
In the absence of a rule, TSCA Order, or consent agreement under
TSCA section 4 covering the chemical substance, persons are required
only to submit information in their possession or control and to
describe any other information known or reasonably ascertainable (see
40 CFR 720.50 or 40 CFR 725.160 [for the microorganism]). However, upon
review of PMNs and SNUNs, the Agency has the authority to require
appropriate testing. Unit IV. lists potentially useful information for
the SNURs listed in this document. Descriptions of this information is
provided for informational purposes. The potentially useful information
identified in Unit IV. will be useful to EPA's evaluation in the event
that someone submits a SNUN for the significant new use.
EPA strongly encourages persons, before performing any testing, to
consult with the Agency. Furthermore, pursuant to TSCA section 4(h),
which pertains to reduction of testing in vertebrate animals, EPA
encourages consultation with the Agency on the use of alternative test
methods and strategies (also called New Approach Methodologies, or
NAMs), if available, to generate the recommended test data. EPA
encourages dialog with Agency representatives to help determine how
best the submitter can meet both the data needs and the objective of
TSCA section 4(h). For more information on alternative test methods and
strategies to reduce vertebrate animal testing, visit https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/alternative-test-methods-and-strategies-reduce.
In some of the TSCA Orders for the chemical substances identified
in this rule, EPA has established time limits in view of the lack of
data on the potential health and environmental risks that may be posed
by the significant new uses or increased exposure to the chemical
substances. These limits cannot be exceeded unless the PMN submitter
first submits the results of specified tests that would permit a
reasoned evaluation of the potential risks posed by these chemical
substances. The SNURs contain the same time limits as the TSCA Orders.
Exceeding these production limits is defined as a significant new use.
Persons who intend to exceed the time limit must notify the Agency by
submitting a SNUN at least 90 days in advance of commencement of non-
exempt commercial manufacture or processing.
Any request by EPA for the triggered and pended testing described
in the TSCA Orders was made based on EPA's consideration of available
screening-level data, if any, as well as other available information on
appropriate testing for the PMN substances. Further, any such testing
request on the part of EPA that includes testing on vertebrates was
made after consideration of available toxicity information,
computational toxicology and bioinformatics, and high-throughput
screening methods and their prediction models.
The potentially useful information listed in Unit IV. may not be
the only means of addressing the potential risks of the chemical
substance. However, submitting a SNUN without any test data or other
information may increase the likelihood that EPA will take action under
TSCA section 5(e) or 5(f). EPA recommends that potential SNUN
submitters contact EPA early enough so that they will be able to
conduct the appropriate tests.
SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs which provide detailed information on the following:
Human exposure and environmental release that may result
from the significant new use of the chemical substances.
Information on risks posed by the chemical substances
compared to risks posed by potential substitutes.
VIII. SNUN Submissions
According to 40 CFR 721.1(c), persons submitting a SNUN must comply
with the same notification requirements and EPA regulatory procedures
as persons submitting a PMN, including submission of test data on
health and environmental effects as described in 40 CFR 720.50. SNUNs
must be submitted on EPA Form No. 7710-25, generated using e-PMN
software, and submitted to the Agency in accordance with the procedures
set forth in 40 CFR 720.40. According to 40 CFR 725.900, persons
submitting an MCAN for a significant new use of a microorganism must
comply with the same notification requirements and EPA regulatory
procedures as persons submitting an MCAN for a new microorganism,
including submission of test data on health and environmental effects
as described in 40 CFR 725.160. E-PMN software is available
electronically at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.
IX. Economic Analysis
EPA has evaluated the potential costs of establishing SNUN
requirements for potential manufacturers and processors of the chemical
substances subject to this proposed rule. EPA's complete economic
analysis is available in the docket for this rulemaking.
X. Statutory and Executive Order Reviews
Additional information about these statutes and Executive orders
can be found at https://www.epa.gov/laws-regulations-and-executive-orders.
A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulations and Regulatory Review
This action proposes to establish SNURs for several new chemical
substances that were the subject of PMNs and an MCAN. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Orders 12866 (58 FR 51735, October 4, 1993) and
13563 (76 FR 3821, January 21, 2011).
B. Paperwork Reduction Act (PRA)
According to the PRA (44 U.S.C. 3501 et seq.), an agency may not
conduct or sponsor, and a person is not required to respond to a
collection of information that requires OMB approval under PRA, unless
it has been approved by OMB and displays a currently valid OMB control
number. The OMB control numbers for EPA's regulations in title 40 of
the CFR, after appearing in the Federal Register, are listed in 40 CFR
part 9, and included on the related collection instrument or form, if
applicable.
The information collection activities associated with SNURs have
already
[[Page 31252]]
been approved by OMB under the PRA and assigned OMB control number
2070-0012 (EPA ICR No. 574). This proposed rule does not contain any
burden requiring additional OMB approval. If an entity were to submit a
SNUN to the Agency, the annual burden is estimated to average between
30 and 170 hours per response. This burden estimate includes the time
needed to review instructions, search existing data sources, gather and
maintain the data needed, and complete, review, and submit the required
SNUN.
Send any comments about the accuracy of the burden estimate, and
any suggested methods for minimizing respondent burden, including using
automated collection techniques, to the Director, Regulatory Support
Division, Office of Mission Support (2822T), Environmental Protection
Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001. Please
remember to include the OMB control number in any correspondence, but
do not submit any completed forms to this address.
C. Regulatory Flexibility Act (RFA)
Pursuant to the RFA section 605(b) (5 U.S.C. 601 et seq.), the
Agency hereby certifies that promulgation of these SNURs would not have
a significant adverse economic impact on a substantial number of small
entities. The requirement to submit a SNUN applies to any person
(including small or large entities) who intends to engage in any
activity described in the final rule as a ``significant new use.''
Because these uses are ``new,'' based on all information currently
available to EPA, it appears that no small or large entities presently
engage in such activities. A SNUR requires that any person who intends
to engage in such activity in the future must first notify EPA by
submitting a SNUN. EPA's experience to date is that, in response to the
promulgation of SNURs covering over 1,000 chemicals, the Agency
receives only a small number of notices per year. For example, the
number of SNUNs received was seven in Federal fiscal year (FY) 2013, 13
in FY2014, six in FY2015, 10 in FY2016, 14 in FY2017, and 18 in FY2018
and only a fraction of these were from small businesses. In addition,
the Agency currently offers relief to qualifying small businesses by
reducing the SNUN submission fee from $16,000 to $2,800. This lower fee
reduces the total reporting and recordkeeping of cost of submitting a
SNUN to about $10,116 for qualifying small firms. Therefore, the
potential economic impacts of complying with this proposed SNUR are not
expected to be significant or adversely impact a substantial number of
small entities. In a SNUR that published in the Federal Register of
June 2, 1997 (62 FR 29684) (FRL-5597-1), the Agency presented its
general determination that final SNURs are not expected to have a
significant economic impact on a substantial number of small entities,
which was provided to the Chief Counsel for Advocacy of the Small
Business Administration.
D. Unfunded Mandates Reform Act (UMRA)
Based on EPA's experience with proposing and finalizing SNURs,
State, local, and Tribal governments have not been impacted by these
rulemakings, and EPA does not have any reasons to believe that any
State, local, or Tribal government will be impacted by this action. As
such, EPA has determined that this proposed rule would not impose any
enforceable duty, contain any unfunded mandate, or otherwise have any
effect on small governments subject to the requirements of UMRA
sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.).
E. Executive Order 13132: Federalism
This action would not have a substantial direct effect on States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government, as specified in Executive Order 13132 (64 FR
43255, August 10, 1999).
F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action would not have Tribal implications because it is not
expected to have substantial direct effects on Indian Tribes. This
action would not significantly nor uniquely affect the communities of
Indian Tribal governments, nor would it involve or impose any
requirements that affect Indian Tribes. Accordingly, the requirements
of Executive Order 13175 (65 FR 67249, November 9, 2000), do not apply
to this action.
G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
This action is not subject to Executive Order 13045 (62 FR 19885,
April 23, 1997), because this is not an economically significant
regulatory action as defined by Executive Order 12866, and this action
does not address environmental health or safety risks
disproportionately affecting children.
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
This action is not subject to Executive Order 13211 (66 FR 28355,
May 22, 2001), because this proposed rule is not expected to affect
energy supply, distribution, or use.
I. National Technology Transfer and Advancement Act (NTTAA)
This action does not involve any technical standards subject to
NTTAA section 12(d) (15 U.S.C. 272 note).
J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations
This action does not entail special considerations of environmental
justice related issues as delineated by Executive Order 12898 (59 FR
7629, February 16, 1994).
List of Subjects in 40 CFR Parts 721 and 725
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: June 4, 2021.
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. 721.11571 through 721.11603 to subpart E to read as
follows:
Subpart E--Significant New Uses for Specific Chemical Substances
* * * * *
Sec.
* * * * *
721.11571 Hindered amine alkyl ester compounds (generic).
721.11572 N-alkyl-dialkyl piperidine (generic).
721.11573 Tetraalkylpiperidinium halide (generic).
721.11574 Tetraalkylpiperidinium hydroxide (generic).
721.11575 Amidoamino quaternary ammonium salt (generic).
721.11576 Tri alkyl, mono alkoxy, fatty acid ester, ammonium salt
(generic).
721.11577 Halogenated aromatic amine (generic).
[[Page 31253]]
721.11578 1,4-Benzenedicarboxylic acid, 1,4-dipentyl ester, branched
and linear.
721.11579 Dialkyltin dialkylcarboxylate (generic).
721.11580 Alkyltin dodecylthioester (generic).
721.11581 Alkyltin tetradecylthioester (generic).
721.11582 Undecanol, branched.
721.11583 Hydroxy alkanoic acid, compds. with aminoalkoxyalcohol-
epoxy polymer-alkanolamine reaction products (generic).
721.11584 1,3-Propanediol, 2-ethyl-2-(hydroxymethyl)-, polymer with
ethyleneamine, 2-(chloromethyl)oxirane, 2-[[4-(1,1-
dimethylethyl)phenoxy]methyl]oxirane, 2,2'-[1,6-
hexanediylbis(oxymethylene)]bis[oxirane], 4,4'-(1-
methylethylidene)bis[phenol], alkyl ether amine, and 2-[(2-
methylphenoxymethyl]oxirane (generic).
721.11585 Benzenepropanoic acid, 3-(2H-benzotriazol-2-yl)-5-(1,1-
dimethylethyl)-4-hydroxy-2,2-bis(hydroxymethyl)butyl ester.
721.11586 1-Octadecanaminium, N,N-dimethyl-N- [3-
(triethoxysilyl)propyl]-, chloride (1:1).
721.11587 2-Propenoic acid, 2-methyl-, 3-methyl-3-buten-1-yl ester.
721.11588 Mixed metal oxide (generic).
721.11589 Amines, polyethylenepoly-, triethylenetetramine fraction,
polymers with guanidine hydrochloride (1:1).
721.11590 Phenol, 4,4'-(1-methylethylidene)bis-, polymer with
3,6,9,12-tetraoxatetradeca-1, 13-diene, glycidyl ether.
721.11591 1,4-Benzenedicarboxylic acid, 1,4-bis(2-phenoxyethyl)
ester.
721.11592 Poly(oxy-1,2-ethanediyl), .alpha.-nonyl-.omega.-hydroxy-,
branched and linear.
721.11593 1-Butanamine, N-butyl-N-[(triethoxysilyl)methyl]-.
721.11594 Alkenylamide (generic).
721.11595 Isoalkylaminium, N-isoalkyl, -N, N-dimethyl chloride
(generic).
721.11596 Aldehyde, polymer with mixed alkane polyamines, 2,2'-[1,4-
alkanediylbis(oxyalkylene)]bis[oxirane], 2-(alkoxyalkyloxirane,
4,4'-(1-alkylidene)bis[phenol], 2,2'-[(1-alkylidene)bis(4,1-
alkyleneoxyalkylene)]bis[oxirane] and 2-(aryloxyalkyl)oxirane,
acetate (salt) (generic).
721.11597 Alkanedioic acid, compds. with substituted arylalkylamine-
arylalcohol disubstituted alkane-the diglycidyl ether of a
arylalcohol disubstituted alkane-epichlorohydrin-aldehyde-2,2'(1-
alkylidene)bis[4,1-aryleneoxy(alkyl-2,1-
alkanediyl)oxyalkylene]]bis[oxirane]-alkanepolyamine polymer-1-[[2-
[(2-aminoalkyl)amino]alkyl]amino]-3-aryloxy-2-alcohol reaction
products (generic).
721.11598 Polyazaalkane with oxirane and methyloxirane, haloalkane
(generic).
721.11599 Dibromoalkyl ether tetrabromobisphenol A (generic).
721.11600 Octonal, 7(or 8)-formyl-.
721.11601 Sulfonium, trisaryl-, 7,7-dialkyl-2-heteropolycyclic-1-
alkanesulfonate (1:1) (generic).
721.11602 Alkenoic acid, polymer with (alkyl alkenyl) polyether
(generic).
* * * * *
Sec. 721.11571 Hindered amine alkyl ester compounds (generic).
(a) Chemical substance and significant new uses subject to
reporting. The chemical substance generically identified as hindered
amine alkyl ester compounds (PMN P-16-167) 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), (a)(2)(i) through (iv), (a)(3) through (6), 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 of confinement of the operation, general and
local ventilation) or administrative control measures (e.g., workplace
policies and procedures) shall be considered and implemented to prevent
exposure, where feasible). For purposes of Sec. 721.63(a)(5),
respirators must provide a National Institute for Occupational Safety
and Health (NIOSH) assigned protection factor (APF) of at least 50. For
purposes of Sec. 721.63(a)(6), the airborne form(s) of the substance
include particulate (including solids or liquid droplets), gas/vapor
(all substances in gas form), and combination gas/vapor and particulate
(gas and liquid/solid physical states are present).
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(2)(i) through (v), (g)(3)(i)
and (ii), (g)(4)(i) through (iii), and (g)(5). For purposes of Sec.
721.72(g)(1), this substance may cause: Skin irritation; respiratory
complications; central nervous system effects; blood effects.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
(iii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4) and (c)(4), where N=1.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (h), and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain modification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11572 N-alkyl-dialkyl piperidine (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as N-
alkyl-dialkyl piperidine (PMN P-16-419) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section. The requirements of this section do not apply to
quantities of the substance after they have been completely reacted
(cured).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) through (iii), (a)(3) through (6), (b), and
(c). When determining which persons are 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 gas/vapor (all substances in the gas form). For purposes of
Sec. 721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (v), (g)(3)(ii),
(g)(4), and (g)(5). For purposes of Sec. 721.72(e), the concentration
is set at 1.0%. For purposes of Sec. 721.72(g)(1), this substance may
cause: Skin corrosion; serious eye damage; acute toxicity; specific
target organ toxicity. For purposes of Sec. 721.72(g)(4), notice to
users: Water release restrictions apply. 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(h).
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4) and (c)(4), where N=286.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i), and (k) are
[[Page 31254]]
applicable to manufacturers and processors of this substance.
(2) Limitation or revocation of certain modification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11573 Tetraalkylpiperidinium halide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
tetraalkylpiperidinium halide (PMN P-16-423) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section. The requirements of this section do not apply
to quantities of the substance after they have been completely reacted
(cured).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (a)(3), (b), and (c). When determining which
persons are likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general, and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. For purposes of
Sec. 721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii) and (v),
(g)(3)(ii), (g)(4), and (g)(5). For purposes of Sec. 721.72(e), the
concentration is set at 1.0%. For purposes of Sec. 721.72(g)(1), the
substance may cause: Acute toxicity; specific target organ toxicity;
reproductive toxicity. For purposes of Sec. 721.72(g)(4), notice to
users: Water release restrictions apply. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(g).
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4) and (c)(4), where N=20.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i), and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain modification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11574 Tetraalkylpiperidinium hydroxide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
tetraalkylpiperidinium hydroxide (PMN P-16-424) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section. The requirements of this section do not apply
to quantities of the substance after they have been completely reacted
(cured).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) through (iii), (a)(3), (b), and (c). When
determining which persons are likely to be exposed as required for
Sec. 721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general, and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. For purposes of Sec. 721.63(b), the concentration is
set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (v), (g)(3)(ii),
(g)(4), and (g)(5). For purposes of Sec. 721.72(e), the concentration
is set at 1.0%. For purposes of Sec. 721.72(g)(1), this substance may
cause: Skin corrosion; serious eye damage; acute toxicity; specific
target organ toxicity; reproductive toxicity. For purposes of Sec.
721.72(g)(4), notice to users: Water release restrictions apply.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k).
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4) and (c)(4), where N=20.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i), and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain 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).
Sec. 721.11575 Amidoamino quaternary ammonium salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
amidoamino quaternary ammonium salt (PMN P-17-235) 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) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k).
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4) and (c)(4), where N=44.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i), and (k) are applicable to manufacturers
and processors of this substance.
(2) Limitation or revocation of certain 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)(i) of
this section.
Sec. 721.11576 Tri alkyl, mono alkoxy, fatty acid ester, ammonium
salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as tri
alkyl, mono alkoxy, fatty acid ester, ammonium salt (PMN P-18-226) 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(k).
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4) and (c)(4), where N=44.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i), and (k) are applicable to manufacturers
and processors of this substance.
[[Page 31255]]
(2) Limitation 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)(i) of
this section.
Sec. 721.11577 Halogenated aromatic amine (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
halogenated aromatic amine (PMN P-17-259) 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
(cured).
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4) and (c)(4), where N=1.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain modification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11578 1,4-Benzenedicarboxylic acid, 1,4-dipentyl ester,
branched and linear.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1,4-
benzenedicarboxylic acid, 1,4-dipentyl ester, branched and linear (PMN
P-18-43; CAS No. 2097734-13-7) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section. The requirements of this section do not apply to
quantities of the PMN substance after they have been completely reacted
(cured).
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4) and (c)(4), where N=2.
(ii) [Reserved]
(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 (k) are applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain modification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11579 Dialkyltin dialkylcarboxylate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
dialkyltin dialkylcarboxylate (PMN P-18-178) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section. The requirements of this section do not apply
to quantities of the substance after they have been completely reacted
(cured).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3) through (6), and (c). When determining which
persons are 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
(including solids or liquid droplets).
(ii) Industrial, commercial, and consumer activities. It is a
significant new use to use the substance other than as a stabilizer for
PVC compounds.
(iii) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (e), (i), and (k) are applicable to manufacturers
and processors of this substance.
(2) Limitation or revocation of certain modification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11580 Alkyltin dodecylthioester (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
alkyltin dodecylthioester (PMN P-18-217) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section. The requirements of this section do not apply to
quantities of the substance after they have been completely reacted
(cured).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3), and (c). When determining which persons are
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) Industrial, commercial, and consumer activities. It is a
significant new use to use the substance other than as a stabilizer for
PVC compounds.
(iii) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (e), (i), and (k) are applicable to manufacturers
and processors of this substance.
(2) Limitation or revocation of certain modification requirements.
The provisions of Sec. 721.185 apply to this section
Sec. 721.11581 Alkyltin tetradecylthioester (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
alkyltin tetradecylthioester (PMN P-18-218) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section. The requirements of this section do not apply
to quantities of the substance after they have been completely reacted
(cured).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3), and (c). When determining which persons are
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
[[Page 31256]]
considered and implemented to prevent exposure, where feasible.
(ii) Industrial, commercial, and consumer activities. It is a
significant new use to use the substance other than as a stabilizer for
PVC compounds.
(iii) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (e), (i), and (k) are applicable to manufacturers
and processors of this substance.
(2) Limitation or revocation of certain modification requirements.
The provisions of Sec. 721.185 apply to this section
Sec. 721.11582 Undecanol, branched.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as undecanol, branched
(PMN P-18-256) 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 PMN
substance after they have been completely reacted (cured).
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(g).
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4) and (c)(4), where N=4.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i), and (k) are applicable to manufacturers
and processors of this substance.
(2) Limitation or revocation of certain modification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11583 Hydroxy alkanoic acid, compds. with
aminoalkoxyalcohol-epoxy polymer-alkanolamine reaction products
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as hydroxy
alkanoic acid, compds. with aminoalkoxyalcohol-epoxy polymer-
alkanolamine reaction products (PMN P-18-283) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) through (iii), (a)(3), (b), and (c). When
determining which persons are reasonably likely to be exposed as
required for Sec. 721.63(a)(1), engineering control measures (e.g.,
enclosure or confinement of the operation, general and local
ventilation) or administrative control measures (e.g., workplace
policies and procedures) shall be considered and implemented to prevent
exposure, where feasible. For purposes of Sec. 721.63(b), the
concentration is set at 1%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72 (a) through (f), (g)(1), (g)(2)(i) and (v), (g)(3)(ii),
(g)(4)(iii), and (g)(5). For purposes of Sec. 721.72(e), the
concentration is set at 1%. For purposes of Sec. 721.72(g)(1), this
substance may cause: Skin irritation; skin sensitization; eye
irritation; specific target organ toxicity; reproductive toxicity.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
(iii) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (h), and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain modification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11584 1,3-Propanediol, 2-ethyl-2-(hydroxymethyl)-, polymer
with ethyleneamine, 2-(chloromethyl)oxirane, 2-[[4-(1,1-
dimethylethyl)phenoxy]methyl]oxirane, 2,2'-[1,6-
hexanediylbis(oxymethylene)]bis[oxirane], 4,4'-(1-
methylethylidene)bis[phenol], alkyl ether amine, and 2-[(2-
methylphenoxymethyl]oxirane (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as 1,3-
propanediol, 2-ethyl-2-(hydroxymethyl)-, polymer with ethyleneamine, 2-
(chloromethyl)oxirane, 2-[[4-(1,1-dimethylethyl)phenoxy]methyl]oxirane,
2,2'-[1,6-hexanediylbis(oxymethylene)]bis[oxirane], 4,4'-(1-
methylethylidene)bis[phenol], alkyl ether amine, and 2-[(2-
methylphenoxymethyl]oxirane (PMN P-18-298) 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 (cured).
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture, process, or use the PMN substance for an application
method that results in inhalation exposure.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4) and (c)(4), where N=50.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i), and (k) are applicable to manufacturers
and processors of this substance.
(2) Limitation or revocation of certain modification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11585 Benzenepropanoic acid, 3-(2H-benzotriazol-2-yl)-5-
(1,1-dimethylethyl)-4-hydroxy-2,2-bis(hydroxymethyl)butyl ester.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as benzenepropanoic
acid, 3-(2H-benzotriazol-2-yl)-5-(1,1-dimethylethyl)-4-hydroxy-2,2-
bis(hydroxymethyl)butyl ester (PMN P-18-310; CAS No. 2101609-93-0) 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 PMN substance after they have
been completely reacted (cured).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) through (iii), (a)(3) through (6), 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
[[Page 31257]]
(APF) of at least 1,000. For purposes of Sec. 721.63(a)(6), the
airborne form(s) of the substance include gas/vapor and particulate.
(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 0.16
mg/m\3\ as an 8-hour time-weighted average. Persons who wish to pursue
NCELs as an alternative to Sec. 721.63 respirator requirements may
request to do so under Sec. 721.30. Persons whose Sec. 721.30
requests to use the NCELs approach are approved by EPA will be required
to follow NCELs provisions comparable to those contained in the
corresponding TSCA section 5(e) consent order.
(B) [Reserved]
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(3)(ii), and (g)(5). For purposes of
Sec. 721.72(e), the concentration is set at 1.0%. For purposes of
Sec. 721.72(g)(1), this substance may cause: Specific target organ
toxicity; reproductive toxicity. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4) and (c)(4), where N=1.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (h), and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain modification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11586 1-Octadecanaminium, N,N-dimethyl-N- [3-
(triethoxysilyl)propyl]-, chloride (1:1).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1-octadecanaminium,
N,N-dimethyl-N- [3-(triethoxysilyl)propyl]-, chloride (1:1) (PMN P-18-
318; CAS No. 62117-57-1) is subject to reporting under this section for
the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(3)(ii), and (g)(5). For purposes of
Sec. 721.72(g)(1), this substance may cause: Skin irritation; eye
irritation; specific target organ toxicity. For purposes of Sec.
721.72(e), the concentration is set at 1.0%. Alternative hazard and
warning statements that meet the criteria of the Globally Harmonized
System and OSHA Hazard Communication Standard may be used.
(ii) Industrial, commercial, and consumer activities. It is a
significant new use to use the substance other than as a surface
treatment for added lubricity and anti-static properties. It is a
significant new use to use the substance in an application method that
results in inhalation exposure to workers.
(iii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4) and (c)(4), where N=1.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (f) through (i), and (k) are applicable to
manufacturers and processors of this substance.
(2) Limitation or revocation of certain modification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11587 2-Propenoic acid, 2-methyl-, 3-methyl-3-buten-1-yl
ester.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2-propenoic acid,
2-methyl-, 3-methyl-3-buten-1-yl ester (PMN P-18-323; CAS No. 156291-
88-2) is subject to reporting under this section for the significant
new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the PMN
substance after they have been completely reacted (cured).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) through (iii), (a)(3) through (6), and (c).
When determining which persons are reasonably likely to be exposed as
required for Sec. 721.63(a)(1) and (a)(4), engineering control
measures (e.g., enclosure or confinement of the operation, general and
local ventilation) or administrative control measures (e.g., workplace
policies and procedures) shall be considered and implemented to prevent
exposure, where feasible. For purposes of Sec. 721.63(a)(5),
respirators must provide a National Institute for Occupational Safety
and Health (NIOSH) assigned protection factor (APF) of at least 50. For
purposes of Sec. 721.63(a)(6), the airborne form(s) of the substance
include particulate (including solids or liquid droplets) and gas/vapor
(all substances in the gas form).
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(2)(i) through (v), (g)(3)(i)
and (ii), (g)(4)(i) through (iii), and (g)(5). For purposes of Sec.
721.72(g)(1), this substance may cause: skin irritation; developmental
effects; systemic effects; respiratory effects; skin sensitization;
respiratory sensitization. Alternative hazard and warning statements
that meet the criteria of the Globally Harmonized System and Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer use. Requirements as
specified in Sec. 721.80(k).
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4) and (c)(4), where N=98.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i), and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.
Sec. 721.11588 Mixed metal oxide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as mixed
metal oxide (PMN P-18-327) is subject to reporting under this section
for the significant new uses described in paragraph (a)(2) of this
section. The requirements of this section do not apply to quantities of
the substance after they have been completely reacted (cured).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3) through (6), 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
[[Page 31258]]
must provide a National Institute for Occupational Safety and Health
(NIOSH) assigned protection factor (APF) of at least 1,000. For
purposes of Sec. 721.63(a)(6), the airborne form(s) of the substance
include particulate (including solids or liquid droplets).
(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 0.1 mg/
m\3\ as an 8-hour time-weighted average. Persons who wish to pursue
NCELs as an alternative to Sec. 721.63 respirator requirements may
request to do so under Sec. 721.30. Persons whose Sec. 721.30
requests to use NCELs approach 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 (d), (f), (g)(1), (g)(2), and (g)(5). For purposes of
Sec. 721.72(g)(1), this substance may cause: cancer; skin
sensitization; respiratory sensitization; specific target organ
toxicity. Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used. For purposes of Sec. 721.72(g)(2),
when using this substance: avoid skin contact, avoid breathing
substance, avoid ingestion, use respiratory protection or maintain
workplace airborne concentrations at or below an 8-hour time-weighted
average of 0.1 mg/m\3\, and use skin protection.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (h) are applicable to manufacturers and processors
of this substance.
(2) Limitation or revocation of certain modification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11589 Amines, polyethylenepoly-, triethylenetetramine
fraction, polymers with guanidine hydrochloride (1:1).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as amines,
polyethylenepoly-, triethylenetetramine fraction, polymers with
guanidine hydrochloride (1:1) (PMN P-18-347; CAS No. 1902936-67-7) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3), (b), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. For purposes of
Sec. 721.63(b), the concentration is set at 1%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) and (v), (g)(3)(i) and (ii),
(g)(4)(i), and (g)(5). For purposes of Sec. 721.72(e), the
concentration is set at 1%. For purposes of Sec. 721.72(g)(1), this
substance may cause: acute toxicity; skin sensitization; specific
target organ toxicity. Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4) and (c)(4), where N=2.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (h), and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11590 Phenol, 4,4'-(1-methylethylidene)bis-, polymer with
3,6,9,12-tetraoxatetradeca-1, 13-diene, glycidyl ether.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as phenol, 4,4'-(1-
methylethylidene)bis-, polymer with 3,6,9,12-tetraoxatetradeca-1, 13-
diene, glycidyl ether (PMN P-18-405; CAS No. 647028-24-8) 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 (cured).
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture, process, or use the PMN substance in a manner that results
in inhalation exposure.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4) and (c)(4), where N=1.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain modification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11591 1,4-Benzenedicarboxylic acid, 1,4-bis(2-phenoxyethyl)
ester.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1,4-
benzenedicarboxylic acid, 1,4-bis(2-phenoxyethyl) ester (PMN P-19-36;
CAS No. 25900-07-6) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the PMN
substance after they have been completely reacted (cured).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (a)(3) through (6), 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
of 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 1,000. For purposes of
Sec. 721.63(a)(6), the airborne form(s) of the substance include
particulate (including solids or liquid droplets).
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4) and (c)(4), where N=3.
(b) Specific requirements. The provisions of subpart A of this part
may apply to this section except as modified by this paragraph (b).
[[Page 31259]]
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (e) and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain modification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11592 Poly(oxy-1,2-ethanediyl), .alpha.-nonyl-.omega.-
hydroxy-, branched and linear.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as poly(oxy-1,2-
ethanediyl), .alpha.-nonyl-.omega.-hydroxy-, branched and linear (PMN
P-19-52; CAS No. 2242406-13-7) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) through (iii), (a)(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 1,000.
For purposes of Sec. 721.63(a)(6), the airborne form(s) of the
substance include particulate (including solids or liquid droplets).
For purposes of Sec. 721.63(b), the concentration is set at 1%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (v), (g)(3)(i) and
(ii), and (g)(5). For purposes of Sec. 721.72(e), the concentration is
set at 1%. For purposes of Sec. 721.72(g)(1), this substance may
cause: Skin irritation; respiratory complications; internal organ
effects; eye corrosion. Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer use. It is a significant
new use to use the substance where the concentration of the substance
in the product formulation intended for distribution in commerce
exceeds 1% by weight.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4) and (c)(4), where N=34.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i), and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain modification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11593 1-Butanamine, N-butyl-N-[(triethoxysilyl)methyl]-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1-Butanamine, N-
butyl-N-[(triethoxysilyl)methyl]- (PMN P-19-53; CAS No. 35501-23-6) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the substance after they have
been completely reacted (cured).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general, and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f) and (o). It is a significant new use to
process and use the substance other than in a liquid formulation.
(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 (e), and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain modification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11594 Alkenylamide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
alkenylamide (PMN P-19-77) 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(k).
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4) and (c)(4), where N=4.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i), and (k) are applicable to manufacturers
and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The 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. 721.11595 Isoalkylaminium, N-isoalkyl, -N, N-dimethyl chloride
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
isoalkylaminium, N-isoalkyl, -N, N-dimethyl chloride (PMN P-19-131) 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) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(3)(ii), and (g)(5). For purposes of
Sec. 721.72(e), the concentration is set at 1%. For purposes of Sec.
721.72(g)(1), this substance may cause: Skin irritation; eye
irritation; specific target organ toxicity. Alternative hazard and
warning statements that meet the criteria of the Globally Harmonized
System and OSHA Hazard Communication Standard may be used.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is significant new use to
manufacture, process, or use the PMN substance in a manner that results
in inhalation exposure.
(iii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4) and (c)(4), where N=1.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
[[Page 31260]]
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (f) through (i), and (k) are applicable to
manufacturers and processors of this substance.
(2) Limitation or revocation of certain modification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11596 Aldehyde, polymer with mixed alkane polyamines, 2,2'-
[1,4-alkanediylbis(oxyalkylene)]bis[oxirane], 2-(alkoxyalkyloxirane,
4,4'-(1-alkylidene)bis[phenol], 2,2'-[(1-alkylidene)bis(4,1-
alkyleneoxyalkylene)]bis[oxirane] and 2-(aryloxyalkyl)oxirane, acetate
(salt) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
aldehyde, polymer with mixed alkane polyamines, 2,2'-[1,4-
alkanediylbis(oxyalkylene)]bis[oxirane], 2-(alkoxyalkyloxirane, 4,4'-
(1-alkylidene)bis[phenol], 2,2'-[(1-alkylidene)bis(4,1-
alkyleneoxyalkylene)]bis[oxirane] and 2-(aryloxyalkyl)oxirane, acetate
(salt) (PMN P-19-143) 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 (cured) or destroyed.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture, process, or use the PMN substance in a manner that results
in inhalation exposure to either the PMN substance or to formaldehyde.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4) and (c)(4), where N=1.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i), and (k) are applicable to manufacturers
and processors of this substance.
(2) Limitation or revocation of certain modification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11597 Alkanedioic acid, compds. with substituted
arylalkylamine-arylalcohol disubstituted alkane-the diglycidyl ether of
a arylalcohol disubstituted alkane-epichlorohydrin-aldehyde-2,2'[(1-
alkylidene)bis[4,1-aryleneoxy(alkyl-2,1-
alkanediyl)oxyalkylene]]bis[oxirane]-alkanepolyamine polymer-1-[[2-[(2-
aminoalkyl)amino]alkyl]amino]-3-aryloxy-2-alcohol reaction products
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
alkanedioic acid, compds. with substituted arylalkylamine-arylalcohol
disubstituted alkane-the diglycidyl ether of a arylalcohol
disubstituted alkane-epichlorohydrin-aldehyde-2,2'[(1-
alkylidene)bis[4,1-aryleneoxy(alkyl-2,1-
alkanediyl)oxyalkylene]]bis[oxirane]-alkanepolyamine polymer-1-[[2-[(2-
aminoalkyl)amino]alkyl]amino]-3-aryloxy-2-alcohol reaction products
(PMN P-19-144) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substance after they have been completely reacted (cured) or destroyed.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture, process, or use the PMN substance in a manner that results
in inhalation exposure to either the PMN substance or to formaldehyde.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4) and (c)(4), where N=1.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i), and (k) are applicable to manufacturers
and processors of this substance.
(2) Limitation or revocation of certain modification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11598 Polyazaalkane with oxirane and methyloxirane,
haloalkane (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
polyazaalkane with oxirane and methyloxirane, haloalkane (PMN P-19-145)
is subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the substance after they have
been completely reacted (cured).
(2) The significant new uses are:
(i) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), and (g)(5). For purposes of Sec.
721.72(e), the concentration is set at 1%. For purposes of Sec.
721.72(g)(1), this substance may cause: reproductive toxicity; specific
target organ toxicity. Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(ii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the PMN substance
in a manner that results in inhalation exposure.
(iii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4) and (c)(4), where N=26.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (f) through (h), (i) and (k) are applicable to
manufacturers and processors of this substance.
(2) Limitation or revocation of certain modification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11599 Dibromoalkyl ether tetrabromobisphenol A (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
dibromoalkyl ether tetrabromobisphenol A (PMN P-19-153) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) and (iii), (a)(3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(3)(ii), and (g)(5). For purposes of
Sec. 721.72(e), the concentration is set at 1%. For purposes of Sec.
721.72(g)(1), this substance may cause: eye irritation;
carcinogenicity;
[[Page 31261]]
reproductive toxicity; specific target organ toxicity. Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (h), and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain modification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11600 Octonal, 7(or 8)-formyl-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as Octonal, 7(or 8)-
formyl- (PMN P-20-29; CAS No. 1607842-40-9) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4) and (c)(4), where N=17.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain modification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11601 Sulfonium, trisaryl-, 7,7-dialkyl-2-heteropolycyclic-
1-alkanesulfonate (1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
sulfonium, trisaryl-, 7,7-dialkyl-2-heteropolycyclic-1-alkanesulfonate
(1:1) (PMN P-20-42) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substance after they have been completely reacted or adhered (during
the photolithographic process) onto a semiconductor wafer surface or
similar manufactured article used in the production of semiconductor
technologies.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) and (iii), (a)(3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e), (g)(1), (g)(2)(i) through (v), (g)(3)(i) and
(ii), and (g)(5). For purposes of Sec. 721.72(e), the concentration is
set at 1%. For purposes of Sec. 721.72(g)(1), this substance may
cause: Skin irritation; acute toxicity; skin sensitization; serious eye
damage; specific target organ toxicity; neurotoxicity; genetic
toxicity; reproductive toxicity. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (k), and (t). It is a significant new
use to import the 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 provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers and processors
of this substance.
(2) Limitation or revocation of certain 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. 721.11602 Alkenoic acid, polymer with (alkyl alkenyl) polyether
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
alkenoic acid, polymer with (alkyl alkenyl) polyether (PMN P-20-104) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the substance after they have
been completely reacted (cured).
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture, process, or use the substance in a manner that results in
inhalation exposure.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4) and (c)(4), where N=75.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i), and (k) are applicable to manufacturers
and processors of this substance.
(2) Limitation or revocation of certain modification requirements.
The provisions of Sec. 721.185 apply to this section.
* * * * *
PART 725-- REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR
MICROORGANISMS
0
3. The authority citation for part 725 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, 2613, and 2625.
0
4. Add Sec. 725.1081 to read as follows:
Sec. 725.1081 Trichoderma reesei (generic).
(a) Microorganism and significant new uses subject to reporting.
(1) The genetically-modified microorganism generically identified as
Trichoderma reesei modified (MCAN J-16-26) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2)(i) It is a significant new use to manufacture, process, or use
the microorganism other than in a fermentation system that meets all of
the following conditions:
(A) Enzyme production occurs by submerged fermentation (i.e., for
enzyme production, growth of the microorganism occurs beneath the
surface of the liquid growth medium); and
(B) Any fermentation of solid plant material or insoluble substrate
to which Trichoderma reesei fermentation broth is added after the
standard industrial fermentation is completed is initiated only after
the inactivation of the
[[Page 31262]]
microorganism as delineated in Sec. 725.422(d).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart L of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
725.950(b)(2) through (4) are applicable to manufacturers and
processors of this microorganism.
(2) Modification or revocation of certain notification
requirements. The provisions of Sec. 725.984 apply to this section.
* * * * *
[FR Doc. 2021-12147 Filed 6-10-21; 8:45 am]
BILLING CODE 6560-50-P
