Proposed Rule2022-13360
Significant New Use Rules on Certain Chemical Substances (21-3.5e)
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 24, 2022
Issuing agencies
Environmental Protection Agency
Abstract
EPA is proposing significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for chemical substances that were the subject of premanufacture notices (PMNs) and are also subject to Orders issued by EPA pursuant to TSCA. The SNURs require persons who intend to manufacture (defined by statute to include import) or process any of these chemical substances for an activity that is proposed as a significant new use by this rule to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA's evaluation of the use, under the conditions of use for that chemical substance, within the applicable review period. Persons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required by that determination.
Full Text
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<title>Federal Register, Volume 87 Issue 121 (Friday, June 24, 2022)</title>
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[Federal Register Volume 87, Number 121 (Friday, June 24, 2022)]
[Proposed Rules]
[Pages 37783-37807]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-13360]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2021-0568; FRL-9779-01-OCSPP]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances (21-
3.5e)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA is proposing significant new use rules (SNURs) under the
Toxic Substances Control Act (TSCA) for chemical substances that were
the subject of premanufacture notices (PMNs) and are also subject to
Orders issued by EPA pursuant to TSCA. The SNURs require persons who
intend to manufacture (defined by statute to include import) or process
any of these chemical substances for an activity that is proposed as a
significant new use by this rule to notify EPA at least 90 days before
commencing that activity. The required notification initiates EPA's
evaluation of the use, under the conditions of use for that chemical
substance, within the applicable review period. Persons may not
commence manufacture or processing for the significant new use until
EPA has conducted a review of the notice, made an appropriate
determination on the notice, and has taken such actions as are required
by that determination.
DATES: Comments must be received on or before July 25, 2022.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2021-0568, through the Federal eRulemaking
Portal at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Follow the online instructions
for submitting comments. Do not submit electronically any information
you consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at <a href="http://www.epa.gov/dockets">http://www.epa.gov/dockets</a>.
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:
<a href="/cdn-cgi/l/email-protection#1e69676d7170793069777272777f735e7b6e7f30797168"><span class="__cf_email__" data-cfemail="addad4dec2c3ca83dac4c1c1c4ccc0edc8ddcc83cac2db">[email protected]</span></a>.
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: <a href="/cdn-cgi/l/email-protection#590d0a1a187411362d3530373c193c2938773e362f"><span class="__cf_email__" data-cfemail="e4b0b7a7a5c9ac8b90888d8a81a4819485ca838b92">[email protected]</span></a>.
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:
<bullet> Manufacturers or processors of one or more subject
chemical substances (NAICS codes 325 and 324110), e.g., chemical
manufacturing and petroleum refineries.
This action may also affect certain entities through pre-existing
import certification and export notification rules under TSCA. Chemical
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import
provisions promulgated at 19 CFR 12.118 through 12.127 and 19 CFR
127.28. Chemical importers must certify that the shipment of the
chemical substance complies with all applicable rules and Orders under
TSCA, which would include the SNUR requirements should these proposed
rules be finalized. The EPA policy in support of import certification
appears at 40 CFR part 707, subpart B. In addition, pursuant to 40 CFR
721.20, any persons who export or intend to export a chemical substance
that is the subject of this proposed rule on or after July 25, 2022 are
subject to the export notification provisions of TSCA section 12(b) (15
U.S.C. 2611(b)) (see 40 CFR 721.20), and must comply with the export
notification requirements in 40 CFR part 707, subpart D.
B. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
<a href="http://regulations.gov">regulations.gov</a> 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 <a href="https://www.epa.gov/dockets/commenting-epa-dockets">https://www.epa.gov/dockets/commenting-epa-dockets</a>.
II. Background
A. What action is the Agency taking?
EPA is proposing these SNURs under TSCA section 5(a)(2) (15 U.S.C.
2604(a)(2)) for certain chemical substances that were the subject of
PMNs. These proposed SNURs would require persons to notify EPA at least
90 days before commencing the manufacture or processing of any of these
chemical substances for an activity proposed as a significant new use.
Receipt of such notices would allow EPA to assess risks and, if
[[Page 37784]]
appropriate, to regulate the significant new use before it may occur.
The docket for these proposed SNURs, identified as docket ID number
EPA-HQ-OPPT-2021-0568, includes information considered by the Agency in
developing these proposed SNURs.
B. What is the Agency's authority for taking this action?
TSCA section 5(a)(2) (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' EPA must make this determination by rule after considering all
relevant factors, including the four TSCA section 5(a)(2) factors
listed in Unit III.
C. Applicability of General Provisions
General provisions for SNURs appear in 40 CFR part 721, subpart A.
These provisions describe persons subject to the rule, recordkeeping
requirements, exemptions to reporting requirements, and applicability
of the rule to uses occurring before the effective date of the rule.
Provisions relating to user fees appear at 40 CFR part 700. Pursuant to
40 CFR 721.1(c), persons subject to these SNURs must comply with the
same significant new use notice (SNUN) requirements and EPA regulatory
procedures as submitters of PMNs under TSCA section 5(a)(1)(A). These
requirements include the information submission requirements of TSCA
sections 5(b) and 5(d)(1), the exemptions authorized by TSCA sections
5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part
720. Once EPA receives a SNUN and before the manufacture or processing
for the significant new use can commence, EPA must either determine
that the use is not likely to present an unreasonable risk of injury
under the conditions of use for the chemical substance or take such
regulatory action as is associated with an alternative determination.
If EPA determines that the use is not likely to present an unreasonable
risk, EPA is required under TSCA section 5(g) to make public, and
submit for publication in the Federal Register, a statement of EPA's
findings.
III. Significant New Use Determination
TSCA section 5(a)(2) states that EPA's determination that a use of
a chemical substance is a significant new use must be made after
consideration of all relevant factors, including:
<bullet> The projected volume of manufacturing and processing of a
chemical substance.
<bullet> The extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical substance.
<bullet> The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance.
<bullet> The reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of a
chemical substance.
In determining what would constitute a significant new use for the
chemical substances that are the subject of these SNURs, EPA considered
relevant information about the toxicity of the chemical substances,
potential human exposures and environmental releases that may be
associated with possible uses of these chemical substances, in the
context of the four TSCA section 5(a)(2) factors listed in this unit.
The proposed rules include PMN substances that are subject to
Orders issued under TSCA section 5(e)(1)(A), as required by the
determinations made under TSCA section 5(a)(3)(B). The TSCA Orders
require protective measures to limit exposures or otherwise mitigate
the potential unreasonable risk. The proposed SNURs identify
significant new uses as any manufacturing, processing, use,
distribution in commerce, or disposal that does not conform to the
restrictions imposed by the underlying TSCA Orders, consistent with
TSCA section 5(f)(4).
Where EPA determined that the PMN substance may present an
unreasonable risk of injury to human health via inhalation exposure to
workers, 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 are approved by EPA will be required to
comply with NCELs provisions that are comparable to those contained in
the corresponding TSCA Order for the same chemical substance.
IV. Substances Subject to This Proposed Rule
EPA is proposing significant new use and recordkeeping requirements
for certain chemical substances in 40 CFR part 721, subpart E. In this
unit, EPA provides the following information for each chemical
substance that is identified in this unit as subject to this proposed
rule:
<bullet> PMN number.
<bullet> Chemical name (generic name, if the specific name is
claimed as CBI).
<bullet> Chemical Abstracts Service (CAS) Registry number (if
assigned for non-confidential chemical identities).
<bullet> Effective date of and basis for the TSCA Order.
<bullet> Potentially Useful Information.
<bullet> 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-18-143
Chemical Name: Fatty acids, tall-oil polymers with aminoalkyl,
dialkyl alkane diamine, polyalkylene polyamine alkanepolyamine
fraction, and tris-[(alkylamino) alkyl] phenol (generic).
CAS Number: Not available.
Effective Date of TSCA Order: April 27, 2021.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the substance will be as an anti-corrosive primer
for outdoor industrial applications. Based on available data on an
analogue, EPA has identified concerns for systemic effects and
reproduction/developmental toxicity. Based on analogue data for the low
molecular weight fraction and information in the Safety Data Sheet, EPA
has also identified concerns for corrosion to all tissues and skin
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:
<bullet> No release of the PMN substance resulting in surface water
concentrations that exceed 1 ppb; and
<bullet> 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.
[[Page 37785]]
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 721.11687.
PMN Number: P-18-154
Chemical Name: Isocyanic acid, polyalkylenepolycycloalkylene ester,
2-alkoxy alkanol and 1-alkoxy alkanol and alkylene diol blocked
(generic).
CAS Number: Not available.
Effective Date of TSCA Order: August 2, 2021.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a crosslinking agent for coatings. Based
on the expected function of the PMN substance as a crosslinking agent
that can crosslink proteins and bind to DNA, EPA has identified
concerns for skin sensitization, respiratory sensitization, and
genotoxicity. Based on comparison to analogous carbamate esters, 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:
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> No use of the PMN substance in a consumer product;
<bullet> No manufacture, processing, or use of the PMN substance in
any manner that results in inhalation exposure;
<bullet> Establishment of a hazard communication program, including
human health and environmental precautionary statements on each label
and in the SDS; and
<bullet> 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 genetic
toxicity, skin sensitization, 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 721.11688.
PMN Number: P-18-273
Chemical Name: 1,4-Cyclohexanedicarboxylic acid, 1,4-bis(2-
ethylhexyl) ester.
CAS Number: 84731-70-4.
Effective Date of TSCA Order: June 9, 2021.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the substance will be for polymer manufacturing.
Based on test data on the PMN substance, EPA has identified concerns
for thyroid 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.
To protect against these risks, the Order requires:
<bullet> No use of the PMN substance other than the confidential
use allowed in the Order;
<bullet> No domestic manufacture of the PMN substance (i.e., import
only);
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure; and
<bullet> 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
toxicokinetics testing may be potentially useful to characterize the
health effects of the PMN substance. Although the Order does not
require these tests, the Order's restrictions remain in effect until
the Order is modified or revoked by EPA based on submission of this or
other relevant information.
CFR Citation: 40 CFR 721.11689.
PMN Number: P-18-290
Chemical Name: Carbomonocylic-oxazolidine (generic).
CAS Number: Not available.
Effective Date of TSCA Order: August 19, 2021.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the substance will be for gas scrubbing and
wastewater deodorizing. Based on the potential release of a hydrolysis
product of the PMN substance, EPA has identified concerns for systemic
effects. Based on comparison to analogous chemical substances, EPA has
identified concerns for eye and respiratory tract irritation. Based on
test data on the PMN substance, EPA predicts that toxicity to aquatic
organisms may occur at concentrations that exceed 285 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:
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> Use of a NIOSH-certified respirator with an APF of at
least 10 where there is a potential for inhalation exposure;
<bullet> Establishment of a hazard communication program, including
human health and environmental precautionary statements on each label
and in the SDS; and
<bullet> No release of the PMN substance resulting in surface water
concentrations that exceed 285 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 eye
irritation, specific target organ toxicity, and chronic aquatic
toxicity testing may be potentially useful to characterize the health
and environmental effects of the PMN substance. Although the Order does
not require these tests, the Order's
[[Page 37786]]
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 721.11690.
PMN Number: P-19-73
Chemical Name: Propoxylated, ethoxylated alkoxyalkyl ether
(generic).
CAS Number: Not available.
Effective Date of TSCA Order: April 22, 2021.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the substance will be as a polymer coatings
additive--low foaming wetting agent. Based on the surfactant properties
and submitted test data on the PMN substance, EPA has identified
concerns for irritation to the eyes, skin, lungs, and mucous membranes;
skin sensitization; and lung effects. Based on comparison to
structurally analogous chemical substances, EPA has also identified
concerns for systemic toxicity. Based on submitted test data on the PMN
substance and comparison to analogous nonionic surfactants, EPA
predicts that toxicity to aquatic organisms may occur at concentrations
that exceed 24 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:
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> Use of a NIOSH-certified respirator with an APF of at
least 1,000 where there is a potential for inhalation exposure;
<bullet> No processing of the PMN substance for use in consumer
products unless the concentration in consumer formulations is less than
1%;
<bullet> Establishment of a hazard communication program, including
human health and environmental precautionary statements on each label
and in the SDS; and
<bullet> No release of the PMN substance resulting in surface water
concentrations that exceed 24 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 effects, eye damage, and specific target organ toxicity
testing may be potentially useful to characterize the health effects of
the PMN substance. Although the Order does not require these tests, the
Order's restrictions remain in effect until the Order is modified or
revoked by EPA based on submission of this or other relevant
information.
CFR Citation: 40 CFR 721.11691.
PMN Number: P-19-98
Chemical Name: Phosphoric acid, polymer with (hydroxyalkyl)-
alkanediol and alkanediol (generic).
CAS Number: Not available.
Effective Date of TSCA Order: May 28, 2021.
Basis for TSCA Order: The PMN states that use of the substance will
be as a flame retardant additive for intumescent coatings. Based on
available data on a residual substance, EPA has identified concerns for
neurotoxicity, developmental effects, and systemic effects. Based on
phosphate esters, EPA has also identified concerns for reproductive
toxicity, neurotoxicity, and systemic effects. Based on phosphoric acid
residual, EPA has also identified concerns for corrosion to the skin,
eyes, and respiratory tract. 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:
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> Use of a NIOSH-certified respirator with an APF of at
least 50 where there is a potential for inhalation exposure;
<bullet> Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS;
<bullet> Use of the PMN substance only as a flame retardant
additive for intumescent coatings;
<bullet> No use of the PMN substance in a consumer product; and
<bullet> No release of the PMN substance resulting in surface water
concentrations that exceed 500 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, skin corrosion, eye corrosion, reproductive toxicity,
and specific target organ toxicity testing may be potentially useful to
characterize the health effects of the PMN substance. Although the
Order does not require these tests, the Order's restrictions remain in
effect until the Order is modified or revoked by EPA based on
submission of this or other relevant information.
CFR Citation: 40 CFR 721.11692.
PMN Numbers: P-19-122 and P-20-83
Chemical Names: 2-Propenoic acid, 2-(hydrogenated animal-based
nitrogen-substituted)ethyl ester (generic) (P-19-122) and 2-propenoic
acid, nitrogen-substituted alkyl, N-C16-18-acyl derivs. (generic) (P-
20-83).
CAS Number: Not available.
Effective Date of TSCA Order: March 17, 2021.
Basis for TSCA Order: The PMNs state that the generic (non-
confidential) uses of the substances will be as reactant monomers in a
polymer for industrial use. Based on the waterproofing properties of
the PMN substances, EPA has identified concerns for lung effects. Based
on comparison to structurally analogous chemical substances, EPA has
also identified concerns for dermal irritation/sensitization, systemic
toxicity, skin/eye corrosion, systemic effects, developmental toxicity,
and male reproductive effects. Based on comparison to analogous
acrylates, 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 substances may present an unreasonable risk of injury
to human health or the environment. To protect against these risks, the
Order requires:
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> Use of a NIOSH-certified respirator with an APF of at
least 50 where there is a potential for inhalation exposure;
<bullet> No domestic manufacture (i.e., import only);
<bullet> No use of the PMN substances in consumer applications;
<bullet> Establishment of a hazard communication program, including
human health and environmental precautionary statements on each label
and in the SDS; and
[[Page 37787]]
<bullet> 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.
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 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 721.11693 (P-19-122) and 40 CFR 721.11694 (P-
20-83).
PMN Number: P-20-5
Chemical Name: Modified graphene (generic).
CAS Number: Not available.
Effective Date of TSCA Order: August 13, 2021.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the substance will be as an additive for plastics
and resins. Based on analogue data, EPA has identified concerns for
lung effects, immunotoxicity, and eye irritation. EPA was unable to
estimate the environmental hazard of this new chemical substance. The
Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient
information to permit a reasoned evaluation, the substance may present
an unreasonable risk of injury to human health or the environment. To
protect against these risks, the Order requires:
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> Use of a NIOSH-certified particulate respirator with an
APF of at least 50 where there is a potential for inhalation exposure;
<bullet> Implementation of dust controls that demonstrate an
exposure reduction of at least 90% where workers are reasonably
expected to be exposed by inhalation to dust from the substance;
<bullet> No processing or use of the PMN substance other than for
the confidential use allowed in the Order;
<bullet> No domestic manufacture of the PMN substance (i.e., import
only);
<bullet> No use of the PMN substance in an application method that
results in inhalation exposure to workers;
<bullet> No direct release of the PMN substance to air;
<bullet> Disposal of the PMN substance only by incineration or
landfill; and
<bullet> No release of the PMN substance to water.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of eye
irritation, pulmonary effects, specific target organ toxicity,
carcinogenicity (lung), 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 721.11695.
PMN Number: P-20-58
Chemical Name: Polysaccharide, polymer with unsaturated carboxylic
acid and methacryloxyethyltrimethyl ammonium chloride, sodium salt,
acid salt initiated (generic).
CAS Number: Not available.
Effective Date of TSCA Order: September 9, 2021.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the substance will be as an additive for automatic
dishwashing and hard surface cleaners. Based on comparison to analogous
chemical substances, EPA has identified concerns for systemic effects.
Based on comparison to analogous chemical substances, EPA predicts that
toxicity to aquatic organisms may occur at concentrations that exceed
102 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:
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> Establishment of a hazard communication program, including
human health and environmental precautionary statements on each label
and in the SDS; and
<bullet> No release of the PMN substance resulting in surface water
concentrations that exceed 102 ppb.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
specific target organ toxicity 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 721.11696.
PMN Numbers: P-20-112, P-20-113, P-20-114, P-20-115, P-20-116, and P-
20-117
Chemical Names: Ashes (residues), reactions products with
dicarboxylic acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-
(trialkoxysilyl)alkoxy]methyl]oxirane (generic) (P-20-112), Ashes
(residues), reactions products with substituted tricarboxylic acid,
silicic acid (H4SiO4) tetra-Et ester and 2-[[3-
(trialkoxysilyl)alkoxy]methyl]oxirane (generic) (P-20-113), Ashes
(residues), reactions products with dicarboxylic acid, silicic acid
(H4SiO4) tetra-Et ester and 2-[[3-(trialkoxysilyl)alkoxy]methyl]oxirane
(generic) (P-20-114), Ashes (residues), reactions products with
substituted tricarboxylic acid, silicic acid (H4SiO4) tetra-Et ester
and 2-[[3- (trialkoxysilyl)alkoxy]methyl]oxirane (generic) (P-20-115),
Ashes (residues), reactions products with dicarboxylic acid, silicic
acid (H4SiO4) tetra-Et ester and 2-[[3-
(trialkoxysilyl)alkoxy]methyl]oxirane (generic) (P-20-116), and Ashes
(residues), reactions products with dicarboxylic acid, silicic acid
(H4SiO4) tetra-Et ester and 2-[[3-(trialkoxysilyl)alkoxy]methyl]oxirane
(generic) (P-20-117).
CAS Numbers: Not available.
Effective Date of TSCA Order: June 15, 2021.
[[Page 37788]]
Basis for TSCA Order: The PMNs state that the use of the substances
will be as additives for polymers (e.g., rubber, plastics, adhesives,
coatings and sealants). Based on the metal content of the PMN
substances, EPA has identified concerns for lung toxicity, acute
toxicity, lung effects, systemic effects, developmental effects,
carcinogenicity, and mutagenicity. Based on silica and metal components
(nickel and vanadium), acid groups, and information in the SDS, EPA has
identified concerns for irritation and sensitization. The Order was
issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I),
based on a finding that in the absence of sufficient information to
permit a reasoned evaluation, the substances may present an
unreasonable risk of injury to human health. To protect against these
risks, the Order requires:
<bullet> Submittal to EPA of metals content analysis of the
confidential immediate precursor used to manufacture the PMN
substances;
<bullet> Use of a NIOSH-certified respirator with an APF of at
least 50 where there is a potential for inhalation exposure or
compliance with a NCEL of 0.05 mg/m\3\ as an 8-hour time-weighted
average to prevent inhalation exposure;
<bullet> No manufacture, processing, or use of the PMN substances
other than at facilities equipped with pollution controls, such as a
bag house, that remove particulates from the air at 99% or greater
efficiency and ensure all air releases from each facility, including
fugitive releases, are filtered through these pollution controls;
<bullet> Use of the PMN substances only for the uses described in
the PMNs; and
<bullet> 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. The submitter has agreed not to exceed the
time limits in the Order without sampling and analyzing the
confidential immediate precursor used to manufacture the PMN substances
via EPA Method 6010B for the following elements: arsenic, barium,
beryllium, cadmium, chromium, cobalt, copper, lead, manganese, mercury,
nickel, selenium, silver, vanadium, and zinc.
CFR Citations: 40 CFR 721.11697 (P-20-112), 40 CFR 721.11698 (P-20-
113), 40 CFR 721.11699 (P-20-114), 40 CFR 721.11700 (P-20-115), 40 CFR
721.11701 (P-20-116), and 40 CFR 721.11702 (P-20-117).
PMN Number: P-20-173
Chemical Name: Silsesquioxanes, alkyl, alkoxy- and hydroxy-
terminated (generic).
CAS Number: Not available.
Effective Date of TSCA Order: June 10, 2021.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the substance will be as a coating additive. Based
on the reactivity of the PMN substance and a structural alert for
alkoxysilanes and siloxanes, EPA has identified concerns for irritation
to the skin, eyes, and respiratory tract and potential lung effects.
Based on comparison to analogous neutral organics and alkoxysilanes,
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:
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> Use of a NIOSH-certified respirator with an APF of at
least 10 where there is a potential for inhalation exposure;
<bullet> Establishment of a hazard communication program, including
human health and environmental precautionary statements on each label
and in the SDS; and
<bullet> 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
specific target organ toxicity, pulmonary 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 721.11703.
PMN Number: P-21-10
Chemical Name: 1,3-Benzenedicarboxylic acid, polymer with 2,2-
dimethyl-1,3-propanediol, 1,2-ethanediol, 2-ethyl-2- (hydroxymethyl)-
1,3-propanediol, hexanedioic acid, 1,6-hexanediol and 1,3-
isobenzofurandione, N-[[1,3,3-trimethyl-5-[[[2-[(1-oxo-2- propen-1-
yl)oxy]ethoxy]carbonyl]amino]cyclohexyl]methyl]carbamate N-[3,3,5-
trimethyl-5-[[[[2-[(1-oxo-2-propen-1-
yl)oxy]ethoxy]carbonyl]amino]methyl]cyclohexyl]carbamate
CAS Number: 2460376-09-2.
Effective Date of TSCA Order: July 1, 2021.
Basis for TSCA Order: The PMN states that the use of the substance
will be in 3D printing. Based on structural alerts for acrylates, EPA
has identified concerns for irritation to the skin, eyes, and
respiratory tract; and skin sensitization. Based on structural alerts
for bifunctional acrylates, EPA has identified a concern for
respiratory sensitization for the low molecular weight species. 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:
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> No manufacture, processing, or use of the PMN substance in
any manner that results in inhalation exposure;
<bullet> No use of the PMN substance in a consumer product; and
<bullet> Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
metabolism/pharmacokinetics, pulmonary effects, skin irritation, eye
irritation, and skin sensitization testing may be potentially useful to
characterize
[[Page 37789]]
the health effects of the PMN substance. Although the Order does not
require these tests, the Order's restrictions remain in effect until
the Order is modified or revoked by EPA based on submission of this or
other relevant information.
CFR Citation: 40 CFR 721.11704.
PMN Number: P-21-13
Chemical Name: Methyl phenylethyl cyclopropanemethanol (generic).
CAS Number: Not available.
Effective Date of TSCA Order: May 20, 2021.
Basis for TSCA Order: The PMN states that use of the substance will
be as a fragrance in fine fragrances; shampoos and body washes;
household products such as laundry detergents and air fresheners; and
deodorants and cosmetics. Based on submitted test data and comparison
to analogous chemical substances, EPA has identified concerns for skin
sensitization and irritation to the eyes and respiratory tract. Based
on comparison to analogous neutral organic chemicals, 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:
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> Use of a NIOSH-certified respirator with an APF of at
least 50 where there is a potential for inhalation exposure;
<bullet> Establishment of a hazard communication program, including
human health and environmental precautionary statements on each label
and in the SDS;
<bullet> Use of the PMN substance in a consumer product only if the
concentration of the PMN substance is less than 1%; and
<bullet> 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 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 721.11705.
PMN Number: P-21-17
Chemical Name: [(Substituted-carbomonocyclic)amino] oxoalkenoic
acid, inorganic salt (generic).
CAS Number: Not available.
Effective Date of TSCA Order: June 16, 2021.
Basis for TSCA Order: The PMN states that the use of the substance
will be to improve physical properties in rubber products. Based on
submitted test data, EPA has identified concerns for systemic effects
and skin sensitization. Based on submitted test data, EPA predicts that
toxicity to aquatic organisms may occur at concentrations that exceed
590 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:
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> Use of a NIOSH-certified particulate respirator with an
APF of at least 50 where there is a potential for inhalation exposure;
<bullet> No domestic manufacture of the PMN substance (i.e., import
only);
<bullet> No use of the PMN substance other than as an additive to
improve physical properties in rubber products; and
<bullet> Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
specific target organ toxicity and skin sensitization testing may be
potentially useful to characterize the health effects of the PMN
substance. Although the Order does not require these tests, the Order's
restrictions remain in effect until the Order is modified or revoked by
EPA based on submission of this or other relevant information.
CFR Citation: 40 CFR 721.11706.
PMN Number: P-21-18
Chemical Name: Sulfonium, triphenyl-, heterocyclic compound-
carboxylate (1:1) (generic).
CAS Number: Not available.
Effective Date of TSCA Order: March 24, 2021.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the substance will be for contained use for
microlithography for electronic device manufacturing. Based on the
physical/chemical properties of the PMN substance (as described in the
New Chemical Program's PBT category at 64 FR 60194; November 1999) and
test data on structurally similar substances, the PMN substance is a
potentially persistent, bioaccumulative, and toxic (PBT) chemical. EPA
estimates that the PMN substance will persist in the environment for
more than 2 months and estimates a bioaccumulation factor of greater
than or equal to 1,000. Based on the photoreactivity of the PMN
substance, EPA has identified concerns for photosensitization. Based on
comparison to analogous substances, EPA has identified concerns for eye
corrosion, irritation, acute toxicity, liver toxicity, neurotoxicity,
and reproductive (developmental) toxicity. The Order was issued under
TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a
finding that in the absence of sufficient information to permit a
reasoned evaluation, the substance may present an unreasonable risk of
injury to human health or the environment. To protect against these
risks, the Order requires:
<bullet> 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;
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> Establishment of a hazard communication program, including
human health and environmental precautionary statements on each label
and in the SDS;
<bullet> No modification of the processing or use of the PMN
substance in any way that generates a vapor, dust, mist, or aerosol in
a non-enclosed process;
<bullet> Use of the PMN substance only as described in the PMN;
[[Page 37790]]
<bullet> No domestic manufacture of the PMN substance (i.e., import
only);
<bullet> Import of the PMN substance only in solution, or in any
form in sealed containers weighing 5 kilograms or less; and
<bullet> 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 721.11707.
PMN Numbers: P-21-23 and P-21-64
Chemical Names: Sulfonium, carbocyclic-, salt with 1-(alkyl) 2-[4-
[polyhydro-2-carbomonocyclic-5-(polyfluoro-2-sulfoalkyl)-4,7-methano-
1,3-benzodioxol-2-yl]carbomonocyclic oxy]acetate (1:1) (generic) (P-21-
23) and sulfonium, triphenyl-, polyfluoro-polyhydrospiro[9H-
carbopolycyclic-9,2'-[4,7]methano[1,3]benzodioxole]-5'-alkenesulfonic
acid (1:1) (generic) (P-21-64).
CAS Numbers: Not available.
Effective Date of TSCA Order: April 20, 2021.
Basis for TSCA Order: The PMNs state that the generic (non-
confidential) use of the substances will be for photolithography. Based
on the physical/chemical properties of the PMN substances (as described
in the New Chemical Program's PBT category at 64 FR 60194; November
1999) and test data on structurally similar substances, the PMN
substances are potentially persistent, bioaccumulative, and toxic (PBT)
chemicals. EPA estimates that the PMN substances will persist in the
environment for more than 2 months and estimates a bioaccumulation
factor of greater than or equal to 1,000. Based on the photoreactivity
of the PMN substances, EPA has identified concerns for
photosensitization. Based on comparison to analogous substances, EPA
has identified concerns for eye corrosion, irritation, acute toxicity,
liver toxicity, and neurotoxicity. Based on positive mutagenicity and
the perfluoro anion analogue, EPA has identified concerns for
reproductive (developmental) toxicity. The Order was issued under TSCA
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding
that in the absence of sufficient information to permit a reasoned
evaluation, the substances may present an unreasonable risk of injury
to human health or the environment. To protect against these risks, the
Order requires:
<bullet> No manufacture of the PMN substances 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;
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> Establishment of a hazard communication program, including
human health and environmental precautionary statements on each label
and in the SDS;
<bullet> No modification of the processing or use of the PMN
substances in any way that generates a vapor, dust, mist, or aerosol in
a non-enclosed process;
<bullet> Use of the PMN substances only as described in the PMNs;
<bullet> No domestic manufacture of the PMN substances (i.e.,
import only);
<bullet> Import of the PMN substances only in solution, or in any
form in sealed containers weighing 5 kilograms or less; and
<bullet> No exceedance of the confidential annual importation
volumes listed the Order.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information about the physical/chemical properties, fate,
bioaccumulation, environmental hazard, and human health effects of the
PMN substances may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. The submitter has agreed not to exceed the
time limits specified in the Order without performing the required Tier
I and Tier II testing outlined in the Testing section of the Order.
CFR Citations: 40 CFR 721.11708 (P-21-23) and 40 CFR 721.11709 (P-
21-64).
PMN Number: P-21-27
Chemical Name: Heteropolycyclic, trihaloalkyl carbomonocycle-,
hydroxy carbomonocyclic salt (generic).
CAS Number: Not available.
Effective Date of TSCA Order: April 20, 2021.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the substance will be as an ingredient used in the
manufacture of photoresists. Based on the physical/chemical properties
of the PMN substance (as described in the New Chemical Program's PBT
category at 64 FR 60194; November 1999) and test data on structurally
similar substances, the PMN substance is a potentially persistent,
bioaccumulative, and toxic (PBT) chemical. EPA estimates that the PMN
substance will persist in the environment for more than 2 months and
estimates a bioaccumulation factor of greater than or equal to 1,000.
Based on the photoreactivity of the PMN substance, EPA has identified
concerns for photosensitization. Based on comparison to analogous
substances, EPA has identified concerns for eye corrosion, irritation,
acute toxicity, liver toxicity, neurotoxicity, and reproductive
(developmental) toxicity. The Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the
absence of sufficient information to permit a reasoned evaluation, the
substance may present an unreasonable risk of injury to human health or
the environment. To protect against these risks, the Order requires:
<bullet> 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;
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> Establishment of a hazard communication program, including
human health and environmental precautionary statements on each label
and in the SDS;
<bullet> No modification of the processing or use of the PMN
substance in any way that generates a vapor, dust, mist, or aerosol in
a non-enclosed process;
<bullet> Use of the PMN substance only as described in the PMN;
<bullet> No domestic manufacture of the PMN substance (i.e., import
only);
<bullet> Import of the PMN substance only in solution, or in any
form in sealed containers weighing 5 kilograms or less; and
[[Page 37791]]
<bullet> 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 721.11710.
PMN Number: P-21-42
Chemical Name: Sulfonium, tricarbocyclic-, 2-heteroatom-
substituted-4-(alkyl)carbomonocyclic carboxylate (1:1) (generic).
CAS Number: Not available.
Effective Date of TSCA Order: April 1, 2021.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the substance will be for photolithography. Based
on the physical/chemical properties of the PMN substance (as described
in the New Chemical Program's PBT category at 64 FR 60194; November
1999) and test data on structurally similar substances, the PMN
substance is a potentially persistent, bioaccumulative, and toxic (PBT)
chemical. EPA estimates that the PMN substance will persist in the
environment for more than 2 months and estimates a bioaccumulation
factor of greater than or equal to 1,000. Based on the photoreactivity
of the PMN substance, EPA has identified concerns for
photosensitization. Based on comparison to analogous substances, EPA
has identified concerns for eye corrosion, irritation, acute toxicity,
liver toxicity, neurotoxicity, and reproductive (developmental)
toxicity. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I)
and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of
sufficient information to permit a reasoned evaluation, the substance
may present an unreasonable risk of injury to human health or the
environment. To protect against these risks, the Order requires:
<bullet> 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;
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> Establishment of a hazard communication program, including
human health and environmental precautionary statements on each label
and in the SDS;
<bullet> No modification of the processing or use of the PMN
substance in any way that generates a vapor, dust, mist, or aerosol in
a non-enclosed process;
<bullet> Use of the PMN substance only as described in the PMN;
<bullet> No domestic manufacture of the PMN substance (i.e., import
only);
<bullet> Import of the PMN substance only in solution, or in any
form in sealed containers weighing 5 kilograms or less; and
<bullet> 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 721.11711.
PMN Number: P-21-54
Chemical Name: 2-Propenoic acid, 2-methyl-, aminoalkyl ester,
polymer with hydroxyalkyl alkenoate and octadecyl alkenoate, acetate
(salts) (generic).
CAS Number: Not available.
Effective Date of TSCA Order: July 23, 2021.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the substance will be as a carpet treatment
additive. Based on structure alerts, EPA has identified concerns for
lung waterproofing and irritation to the skin, eyes, and respiratory
tract. Based on comparison to analogous polycationic polymers, EPA
predicts that toxicity to aquatic organisms may occur at concentrations
that exceed 52 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:
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> No use of the PMN substance in a product that is applied
by a consumer;
<bullet> No manufacture or processing of the PMN substance in any
manner that results in inhalation exposure;
<bullet> No use of the PMN substance in an application method that
results in inhalation exposure;
<bullet> Establishment of a hazard communication program, including
human health and environmental precautionary statements on each label
and in the SDS; and
<bullet> No release of the PMN substance resulting in surface water
concentrations that exceed 52 ppb.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
specific target organ toxicity, skin irritation, eye irritation, 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 721.11712.
PMN Number: P-21-63
Chemical Name: Heterocyclic-polycarboxylic acid, polyhaloaryl-
polyhydro-alkyl-polyalkyl ester (generic).
CAS Number: Not available.
Effective Date of TSCA Order: August 10, 2021.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the substance will be as a component in
herbicides. Based on test data on the PMN substance, EPA has identified
concerns for acute toxicity, phototoxicity (skin irritation),
reproductive effects, and developmental effects. Based on test data on
the PMN substance, EPA predicts that toxicity to
[[Page 37792]]
aquatic organisms may occur at concentrations that exceed 18 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:
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> No use of the PMN substance in a consumer product;
<bullet> Establishment of a hazard communication program, including
human health and environmental precautionary statements on each label
and in the SDS; and
<bullet> No release of the PMN substance to water.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of 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 721.11713.
PMN Number: P-21-65
Chemical Name: Alkenoic acid, reaction products with alkylamine-
alkanediyl diacrylate polymer and [oxybis(alkylene)]bis[alkyl-
alkanediol] (generic).
CAS Number: Not available.
Effective Date of TSCA Order: June 21, 2021.
Basis for TSCA Order: The PMN states that the use of the substance
will be to improve the reactivity of ink formulation when cured under
LED UV light. Based on structural alerts for cationic binding and for
acrylates, EPA has identified concerns for lung effects and skin and
eye irritation. 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.
To protect against these risks, the Order requires:
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> Use of a NIOSH-certified particulate respirator with an
APF of at least 1,000 where there is a potential for inhalation
exposure;
<bullet> No use of the PMN substance in a spray application;
<bullet> No use of the PMN substance in a consumer product; and
<bullet> Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
specific target organ toxicity, pulmonary effects, skin irritation, eye
damage, and skin sensitization testing may be potentially useful to
characterize the health effects of the PMN substance. Although the
Order does not require these tests, the Order's restrictions remain in
effect until the Order is modified or revoked by EPA based on
submission of this or other relevant information.
CFR Citation: 40 CFR 721.11714.
PMN Number: P-21-125
Chemical Name: Nonane, branched.
CAS Number: 85408-10-2.
Effective Date of TSCA Order: September 17, 2021.
Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the substance will be for contained use for
microlithography for electronic device manufacturing. Based on the
physical/chemical properties of an analogue, isooctane, EPA has
identified concerns for aspiration. Based on test data for an analogue
of a potential metabolite, EPA has identified concerns for skin
irritation, eye irritation, and systemic, reproductive, and
developmental effects. Based on comparison to analogous neutral organic
substances, EPA predicts that toxicity to aquatic organisms may occur
at concentrations that exceed 5 ppb. The Order was issued under TSCA
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding
that in the absence of sufficient information to permit a reasoned
evaluation, the substance may present an unreasonable risk of injury to
human health or the environment. To protect against these risks, the
Order requires:
<bullet> Use of personal protective equipment where there is a
potential for dermal exposure;
<bullet> Use of a NIOSH-certified particulate respirator with an
APF of at least 50 where there is a potential for inhalation exposure
or compliance with a NCEL of 0.72 mg/m3 as an 8-hour time-weighted
average to prevent inhalation exposure;
<bullet> No use of the PMN substance other than for the
confidential use allowed in the Order;
<bullet> Establishment of a hazard communication program, including
human health and environmental precautionary statements on each label
and in the SDS; and
<bullet> No release of the PMN substance to water.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of eye
damage, reproductive toxicity, skin irritation, specific target organ
toxicity, and aquatic toxicity testing may be potentially useful to
characterize the health and environmental effects of the PMN substance.
Although the Order does not require these tests, the Order's
restrictions remain in effect until the Order is modified or revoked by
EPA based on submission of this or other relevant information.
CFR Citation: 40 CFR 721.11715.
V. Rationale and Objectives of the Proposed Rule
A. Rationale
During review of the PMNs submitted for the chemical substances
that are the subject to these proposed SNURs, EPA concluded that
regulation was warranted under TSCA section 5(e), pending the
development of information sufficient to make reasoned evaluations of
the health or environmental effects of the chemical substances. The
basis for such findings is outlined in Unit IV. Based on these
findings, TSCA section 5(e) Orders requiring the use of appropriate
exposure controls were negotiated with the PMN submitters. As a general
matter, EPA believes it is necessary to follow the TSCA Orders with a
SNUR that identifies the absence of those protective measures as
[[Page 37793]]
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:
<bullet> 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).
<bullet> 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.
<bullet> To be able to either determine that the prospective
manufacture or processing is not likely to present an unreasonable
risk, or to take necessary regulatory action associated with any other
determination, before the described significant new use of the chemical
substance occurs.
VI. Applicability of the Proposed Significant New Use Designation
To establish a significant new use, EPA must determine that the use
is not ongoing. The chemical substances subject to this proposed rule
have undergone premanufacture review. In cases where EPA has not
received a notice of commencement (NOC) and the chemical substance has
not been added to the TSCA Inventory, no person may commence such
activities without first submitting a PMN. Therefore, for chemical
substances for which an NOC has not been submitted EPA concludes that
the designated significant new uses are not ongoing.
When chemical substances identified in this proposed rule are added
to the TSCA Inventory, EPA recognizes that, before the rule is
effective, other persons might engage in a use that has been identified
as a significant new use. However, TSCA Orders have been issued for
these chemical substances, and the PMN submitters are prohibited by the
TSCA Orders from undertaking activities which would be designated as
significant new uses. The identities of many of the chemical substances
subject to this proposed rule have been claimed as confidential per 40
CFR 720.85. Based on this, the Agency believes that it is highly
unlikely that any of the significant new uses described in the
regulatory text of this proposed rule are ongoing.
Therefore, EPA designates June 24, 2022 as the cutoff date for
determining whether the new use is ongoing. The objective of EPA's
approach is to ensure that a person cannot defeat a SNUR by initiating
a significant new use before the effective date of the final rule.
In the unlikely event that a person began commercial manufacture or
processing of the chemical substances for a significant new use
identified as of that cutoff date, they would have to cease any such
activity upon the effective date of the final rule. To resume their
activities, these persons would have to first comply with all
applicable SNUR notification requirements and wait until EPA has
conducted a review of the notice, made an appropriate determination on
the notice, and has taken such actions as are required with that
determination.
Issuance of a SNUR for a chemical substance does not signify that
the chemical substance is listed on the TSCA Chemical Substance
Inventory (TSCA Inventory). Guidance on how to determine if a chemical
substance is on the TSCA Inventory is available on the internet at
<a href="https://www.epa.gov/tsca-inventory">https://www.epa.gov/tsca-inventory</a>.
VII. Development and Submission of Information
EPA recognizes that TSCA section 5 does not require developing any
particular new information (e.g., generating test data) before
submission of a SNUN. There is an exception: If a person is required to
submit information for a chemical substance pursuant to a rule, TSCA
Order or consent agreement under TSCA section 4, then TSCA section
5(b)(1)(A) requires such information to be submitted to EPA at the time
of submission of the SNUN.
In the absence of a rule, TSCA Order, or consent agreement under
TSCA section 4 covering the chemical substance, persons are required
only to submit information in their possession or control and to
describe any other information known or reasonably ascertainable (see
40 CFR 720.50). However, upon review of PMNs and SNUNs, the Agency has
the authority to require appropriate testing. Unit IV. lists
potentially useful information for the SNURs listed in this document.
Descriptions of this information is provided for informational
purposes. The potentially useful information identified in Unit IV.
will be useful to EPA's evaluation in the event that someone submits a
SNUN for the significant new use.
EPA strongly encourages persons, before performing any testing, to
consult with the Agency. Furthermore, pursuant to TSCA section 4(h),
which pertains to reduction of testing in vertebrate animals, EPA
encourages dialog with the Agency on the use of alternative test
methods and strategies (also called New Approach Methodologies, or
NAMs), if available, to generate the recommended test data. EPA
encourages dialog with Agency representatives to help determine how
best the submitter can meet both the data needs and the objective of
TSCA section 4(h). For more information on alternative test methods and
strategies to reduce vertebrate animal testing, visit <a href="https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/alternative-test-methods-and-strategies-reduce">https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/alternative-test-methods-and-strategies-reduce</a>.
In some of the TSCA Orders for the chemical substances identified
in this proposed 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.
[[Page 37794]]
SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs which provide detailed information on the following:
<bullet> Human exposure and environmental release that may result
from the significant new use of the chemical substances.
<bullet> Information on risks posed by the chemical substances
compared to risks posed by potential substitutes.
VIII. SNUN Submissions
According to 40 CFR 721.1(c), persons submitting a SNUN must comply
with the same notification requirements and EPA regulatory procedures
as persons submitting a PMN, including submission of test data on
health and environmental effects as described in 40 CFR 720.50. SNUNs
must be submitted on EPA Form No. 7710-25, generated using e-PMN
software, and submitted to the Agency in accordance with the procedures
set forth in 40 CFR 720.40. E-PMN software is available electronically
at <a href="https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca">https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca</a>.
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 <a href="https://www.epa.gov/laws-regulations-and-executive-orders">https://www.epa.gov/laws-regulations-and-executive-orders</a>.
A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulations and Regulatory Review
This action proposes to establish SNURs for several new chemical
substances that were the subject of PMNs. The Office of Management and
Budget (OMB) has exempted these types of actions from review under
Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR
3821, January 21, 2011).
B. Paperwork Reduction Act (PRA)
According to the PRA (44 U.S.C. 3501 et seq.), an agency may not
conduct or sponsor, and a person is not required to respond to a
collection of information that requires OMB approval under PRA, unless
it has been approved by OMB and displays a currently valid OMB control
number. The OMB control numbers for EPA's regulations in title 40 of
the CFR, after appearing in the Federal Register, are listed in 40 CFR
part 9, and included on the related collection instrument or form, if
applicable.
The information collection activities associated with SNURs have
already been approved by OMB under the PRA and assigned OMB control
number 2070-0012 (EPA ICR No. 574). This proposed rule does not contain
any burden requiring additional OMB approval. If an entity were to
submit a SNUN to the Agency, the annual burden is estimated to average
between 30 and 170 hours per response. This burden estimate includes
the time needed to review instructions, search existing data sources,
gather and maintain the data needed, and complete, review, and submit
the required SNUN.
Send any comments about the accuracy of the burden estimate, and
any suggested methods for minimizing respondent burden, including using
automated collection techniques, to the Director, Regulatory Support
Division, Office of Mission Support (2822T), Environmental Protection
Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001. Please
remember to include the OMB control number in any correspondence, but
do not submit any completed forms to this address.
C. Regulatory Flexibility Act (RFA)
Pursuant to the RFA section 605(b) (5 U.S.C. 601 et seq.), the
Agency hereby certifies that promulgation of these SNURs would not have
a significant adverse economic impact on a substantial number of small
entities. The requirement to submit a SNUN applies to any person
(including small or large entities) who intends to engage in any
activity described in the final rule as a ``significant new use.''
Because these uses are ``new,'' based on all information currently
available to EPA, it appears that no small or large entities presently
engage in such activities. A SNUR requires that any person who intends
to engage in such activity in the future must first notify EPA by
submitting a SNUN. EPA's experience to date is that, in response to the
promulgation of SNURs covering over 1,000 chemicals, the Agency
receives only a small number of notices per year. For example, the
number of SNUNs received was seven in Federal fiscal year (FY) 2013, 13
in FY2014, six in FY2015, 10 in FY2016, 14 in FY2017, and 18 in FY2018
and only a fraction of these were from small businesses. In addition,
the Agency currently offers relief to qualifying small businesses by
reducing the SNUN submission fee from $16,000 to $2,800. This lower fee
reduces the total reporting and recordkeeping of cost of submitting a
SNUN to about $10,116 for qualifying small firms. Therefore, the
potential economic impacts of complying with this proposed SNUR are not
expected to be significant or adversely impact a substantial number of
small entities. In a SNUR that published in the Federal Register of
June 2, 1997 (62 FR 29684) (FRL-5597-1), the Agency presented its
general determination that final SNURs are not expected to have a
significant economic impact on a substantial number of small entities,
which was provided to the Chief Counsel for Advocacy of the Small
Business Administration.
D. Unfunded Mandates Reform Act (UMRA)
Based on EPA's experience with proposing and finalizing SNURs,
State, local, and Tribal governments have not been impacted by these
rulemakings, and EPA does not have any reasons to believe that any
State, local, or Tribal government will be impacted by this action. As
such, EPA has determined that this proposed rule would not impose any
enforceable duty, contain any unfunded mandate, or otherwise have any
effect on small governments subject to the requirements of UMRA
sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.).
E. Executive Order 13132: Federalism
This action would not have a substantial direct effect on States,
on the relationship between the National Government and the States, or
on the distribution of power and responsibilities among the various
levels of government, as specified in Executive Order 13132 (64 FR
43255, August 10, 1999).
F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action would not have Tribal implications because it is not
expected to have substantial direct effects on Indian Tribes. This
action would not significantly nor uniquely affect the communities of
Indian Tribal governments, nor would it involve or impose any
requirements that affect Indian Tribes. Accordingly, the requirements
of Executive Order 13175 (65 FR 67249, November 9, 2000), do not apply
to this action.
[[Page 37795]]
G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
This action is not subject to Executive Order 13045 (62 FR 19885,
April 23, 1997), because this is not an economically significant
regulatory action as defined by Executive Order 12866, and this action
does not address environmental health or safety risks
disproportionately affecting children.
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
This action is not subject to Executive Order 13211 (66 FR 28355,
May 22, 2001), because this proposed rule is not expected to affect
energy supply, distribution, or use.
I. National Technology Transfer and Advancement Act (NTTAA)
This action does not involve any technical standards subject to
NTTAA section 12(d) (15 U.S.C. 272 note).
J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations
This action does not entail special considerations of environmental
justice related issues as delineated by Executive Order 12898 (59 FR
7629, February 16, 1994).
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: June 15, 2022.
Tala Henry,
Deputy Director, Office of Pollution Prevention and Toxics.
Therefore, for the reasons stated in the preamble, EPA proposes to
amend 40 CFR chapter I as set forth below:
PART 721--SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES
0
1. The authority citation for part 721 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
0
2. Add Sec. Sec. 721.11687 through 721.11715 to subpart E to read as
follows:
Subpart E--Significant New Uses for Specific Chemical Substances
Sec.
* * * * *
721.11687 Fatty acids, tall-oil polymers with aminoalkyl, dialkyl
alkane diamine, polyalkylene polyamine alkanepolyamine fraction, and
tris-[(alkylamino) alkyl] phenol (generic).
721.11688 Isocyanic acid, polyalkylenepolycycloalkylene ester, 2-
alkoxy alkanol and 1-alkoxy alkanol and alkylene diol blocked
(generic).
721.11689 1,4-Cyclohexanedicarboxylic acid, 1,4-bis(2-ethylhexyl)
ester.
721.11690 Carbomonocylic-oxazolidine (generic).
721.11691 Propoxylated, ethoxylated alkoxyalkyl ether (generic).
721.11692 Phosphoric acid, polymer with (hydroxyalkyl)-alkanediol
and alkanediol (generic).
721.11693 2-Propenoic acid, 2-(hydrogenated animal-based nitrogen-
substituted)ethyl ester.
721.11694 2-Propenoic acid, nitrogen-substituted alkyl, N-C16-18-
acyl derivs. (generic).
721.11695 Modified graphene (generic).
721.11696 Polysaccharide, polymer with unsaturated carboxylic acid
and methacryloxyethyltrimethyl ammonium chloride, sodium salt, acid
salt initiated (generic).
721.11697 Ashes (residues), reactions products with dicarboxylic
acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-
(trialkoxysilyl)alkoxy]methyl]oxirane (generic) (P-20-112)
721.11698 Ashes (residues), reactions products with substituted
tricarboxylic acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-
(trialkoxysilyl)alkoxy]methyl]oxirane (generic) (P-20-113)
721.11699 Ashes (residues), reactions products with dicarboxylic
acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-
(trialkoxysilyl)alkoxy]methyl]oxirane (generic) (P-20-114)
721.11700 Ashes (residues), reactions products with substituted
tricarboxylic acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-
(trialkoxysilyl)alkoxy]methyl]oxirane (generic) (P-20-115)
721.11701 Ashes (residues), reactions products with dicarboxylic
acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-
(trialkoxysilyl)alkoxy]methyl]oxirane (generic) (P-20-116)
721.11702 Ashes (residues), reactions products with dicarboxylic
acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-
(trialkoxysilyl)alkoxy]methyl]oxirane (generic) (P-20-117)
721.11703 Silsesquioxanes, alkyl, alkoxy- and hydroxy- terminated
(generic).
721.11704 1,3-Benzenedicarboxylic acid, polymer with 2,2-dimethyl-
1,3-propanediol, 1,2-ethanediol, 2-ethyl-2- (hydroxymethyl)- 1,3-
propanediol, hexanedioic acid, 1,6-hexanediol and 1,3-
isobenzofurandione, N-[[1,3,3-trimethyl-5-[[[2-[(1-oxo-2- propen-1-
yl)oxy]ethoxy]carbonyl]amino]cyclohexyl]methyl]carbamate N-[3,3,5-
trimethyl-5-[[[[2-[(1-oxo-2-propen-1-
yl)oxy]ethoxy]carbonyl]amino]methyl]cyclohexyl]carbamate.
721.11705 Methyl phenylethyl cyclopropanemethanol (generic).
721.11706 [(Substituted-carbomonocyclic)amino] oxoalkenoic acid,
inorganic salt (generic).
721.11707 Sulfonium, triphenyl-, heterocyclic compound-carboxylate
(1:1) (generic).
721.11708 Sulfonium, carbocyclic-, salt with 1-(alkyl) 2-[4-
[polyhydro-2-carbomonocyclic-5-(polyfluoro-2-sulfoalkyl)-4,7-
methano-1,3-benzodioxol-2-yl]carbomonocyclic oxy]acetate (1:1)
(generic).
721.11709 Sulfonium, triphenyl-, polyfluoro-polyhydrospiro[9H-
carbopolycyclic-9,2'-[4,7]methano[1,3]benzodioxole]-5'-
alkenesulfonic acid (1:1) (generic).
721.11710 Heteropolycyclic, trihaloalkyl carbomonocycle-, hydroxy
carbomonocyclic salt (generic).
721.11711 Sulfonium, tricarbocyclic-, 2-heteroatom-substituted-4-
(alkyl)carbomonocyclic carboxylate (1:1) (generic).
721.11712 2-Propenoic acid, 2-methyl-, aminoalkyl ester, polymer
with hydroxyalkyl alkenoate and octadecyl alkenoate, acetate (salts)
(generic).
721.11713 Heterocyclic-polycarboxylic acid, polyhaloaryl-polyhydro-
alkyl-polyalkyl ester (generic).
721.11714 Alkenoic acid, reaction products with alkylamine-
alkanediyl diacrylate polymer and [oxybis(alkylene)]bis[alkyl-
alkanediol] salt (generic).
721.11715 Nonane, branched.
Sec. 721.11687 Fatty acids, tall-oil polymers with aminoalkyl,
dialkyl alkane diamine, polyalkylene polyamine alkanepolyamine
fraction, and tris-[(alkylamino) alkyl] phenol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as fatty
acids, tall-oil polymers with aminoalkyl, dialkyl alkane diamine,
polyalkylene polyamine alkanepolyamine fraction, and tris-[(alkylamino)
alkyl] phenol (PMN P-18-143) 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 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).
(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.
[[Page 37796]]
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11688 Isocyanic acid, polyalkylenepolycycloalkylene ester,
2-alkoxy alkanol and 1-alkoxy alkanol and alkylene diol blocked
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
isocyanic acid, polyalkylenepolycycloalkylene ester, 2-alkoxy alkanol
and 1-alkoxy alkanol and alkylene diol blocked (PMN P-18-154) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(3), and (g)(5). For purposes of
Sec. 721.72(g)(1), this substance may cause: skin sensitization;
respiratory sensitization; germ cell mutagenicity. For purposes of
Sec. 721.72(g)(3), this substance may be: toxic to aquatic life.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure.
(iv) 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 (i), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11689 1,4-Cyclohexanedicarboxylic acid, 1,4-bis(2-
ethylhexyl) ester.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1,4-
cyclohexanedicarboxylic acid, 1,4-bis(2-ethylhexyl) ester (PMN P-18-
273; CAS No. 84731-70-4) 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), (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 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), and (g)(5). For purposes of Sec.
721.72(e), the concentration is set at 1.0%. For purposes of Sec.
721.72(g)(1), this substance may cause: specific target organ toxicity.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f) and (k).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(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. 721.11690 Carbomonocylic-oxazolidine (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
carbomonocylic-oxazolidine (PMN P-18-290) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3) through (5), (a)(6)(v) and (vi), (b), and (c).
When determining which persons are reasonably likely to be exposed as
required for Sec. 721.63(a)(1) and (a)(4), engineering control
measures (e.g., enclosure or confinement of the operation, general and
local ventilation) or administrative control measures (e.g., workplace
policies and procedures) shall be considered and implemented to prevent
exposure, where feasible. For purposes of Sec. 721.63(a)(5),
respirators must provide a National Institute for Occupational Safety
and Health (NIOSH) assigned protection factor (APF) of at least 10. For
purposes of Sec. 721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(3), and (g)(5). For purposes of
Sec. 721.72(e), the concentration is set at 1.0%. For purposes of
Sec. 721.72(g)(1), this substance may cause: eye irritation; specific
target organ toxicity. For purposes of Sec. 721.72(g)(3), this
substance may be: toxic to aquatic life. 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=285.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (h), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11691 Propoxylated, ethoxylated alkoxyalkyl ether
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
propoxylated, ethoxylated alkoxyalkyl ether (PMN P-19-73) 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
[[Page 37797]]
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 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) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(3), and (g)(5). For purposes of
Sec. 721.72(g)(1), this substance may cause: skin irritation; serious
eye damage; specific target organ toxicity. For purposes of Sec.
721.72(g)(3), this substance may be: toxic to aquatic life. Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to process the substance for use in a consumer
product where the concentration of the substance is 1% or greater in
the consumer product formulation.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N=24.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11692 Phosphoric acid, polymer with (hydroxyalkyl)-
alkanediol and alkanediol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
phosphoric acid, polymer with (hydroxyalkyl)-alkanediol and alkanediol
(PMN P-19-98) 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), (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 50. For purposes of Sec.
721.63(b), the concentration is set at 1.0%. For purposes of Sec.
721.63(a)(6), the airborne form(s) of the substance include:
particulate (including solids or liquid droplets).
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), and (g)(5). For purposes of Sec.
721.72(e), the concentration is set at 1.0%. For purposes of Sec.
721.72(g)(1), this substance may cause: skin corrosion; severe eye
damage; reproductive toxicity; specific target organ toxicity.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to use the
substance other than as a flame retardant additive for intumescent
coatings.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N=500.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11693 2-Propenoic acid, 2-(hydrogenated animal-based
nitrogen-substituted)ethyl ester.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as 2-
propenoic acid, 2-(hydrogenated animal-based nitrogen-substituted)ethyl
ester (PMN P-19-122) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substance after they have been completely reacted (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 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).
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(3), and (g)(5). For purposes of
Sec. 721.72(g)(1), this substance may cause: skin corrosion; serious
eye damage; skin sensitization; reproductive toxicity; specific target
organ toxicity. For purposes of Sec. 721.72(g)(3), this substance may
be: toxic to aquatic life. Alternative hazard and warning statements
that meet the criteria of the Globally Harmonized System and OSHA
Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f). It is a significant new use to use the
substance in consumer applications.
(iv) 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 (i), and (k) are applicable to manufacturers,
importers, and processors of this substance.
[[Page 37798]]
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11694 2-Propenoic acid, nitrogen-substituted alkyl, N-C16-
18-acyl derivs. (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as 2-
propenoic acid, nitrogen-substituted alkyl, N-C16-18-acyl derivs. (PMN
P-20-83) 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 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).
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(3), and (g)(5). For purposes of
Sec. 721.72(g)(1), this substance may cause: skin corrosion, serious
eye damage, skin sensitization, reproductive toxicity, and specific
target organ toxicity. For purposes of Sec. 721.72(g)(3), this
substance may be: toxic to aquatic life. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f). It is a significant new use to use the
substance in consumer applications.
(iv) 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 (i), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11695 Modified graphene (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
modified graphene (PMN P-20-5) 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), embedded into a thermoset polymer resin as an intermediate
step before curing, or embedded into a permanent solid polymer form
that is not intended to undergo further processing, except mechanical
processing or physical blending.
(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. Where workers are reasonably expected to be exposed by
inhalation to dust from the substance, dust controls shall be
implemented that demonstrate an exposure reduction of at least 90%. 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).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f) and (k). It is a significant new use to
use the substance in an application method that results in inhalation
exposure to workers.
(iii) Disposal. Requirements as specified in Sec. 721.85(a)(1),
(a)(2), (b)(1), (b)(2), (c)(1), and (c)(2). It is a significant new use
to release the substance directly to air.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (e) and (i) through (k) are applicable to
manufacturers, importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.
Sec. 721.11696 Polysaccharide, polymer with unsaturated carboxylic
acid and methacryloxyethyltrimethyl ammonium chloride, sodium salt,
acid salt initiated (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polysaccharide, polymer with unsaturated carboxylic acid and
methacryloxyethyltrimethyl ammonium chloride, sodium salt, acid salt
initiated (PMN P-20-58) 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), (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 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(3), and (g)(5). For purposes of
Sec. 721.72(e), the concentration is set at 1.0%. For purposes of
Sec. 721.72(g)(1), this substance may cause: specific target organ
toxicity. For the purposes of Sec. 721.72(g)(3), this substance may
be: toxic to aquatic life. Alternative hazard and warning statements
that meet the criteria of the Globally Harmonized
[[Page 37799]]
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=102.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (h), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11697 Ashes (residues), reactions products with
dicarboxylic acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-
(trialkoxysilyl)alkoxy]methyl]oxirane (generic) (P-20-112).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as ashes
(residues), reactions products with dicarboxylic acid, silicic acid
(H4SiO4) tetra-Et ester and 2-[[3-(trialkoxysilyl)alkoxy]methyl]oxirane
(PMN P-20-112) 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 incorporated into a polymer
matrix.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(4) through (6), (b), and (c). When determining which persons
are reasonably likely to be exposed as required for Sec. 721.63(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). For purposes of Sec. 721.63(b), the concentration is
set at 0.1%.
(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 Order for this substance. The NCEL is 0.05 mg/m\3\ as an 8-hour
time weighted average. Persons who wish to pursue NCELs as an
alternative to Sec. 721.63 respirator requirements may request to do
so under Sec. 721.30. Persons whose Sec. 721.30 requests to use the
NCEL approach are approved by EPA will be required to follow NCEL
provisions comparable to those contained in the corresponding TSCA
Order.
(B) [Reserved]
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1)(ii) through (ix), (g)(2) and (g)(5). For
purposes of Sec. 721.72(e), the concentration is set at 0.1%. For
purposes of Sec. 721.72(g)(2), 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 0.05 mg/m\3\; use skin protection. Alternative hazard and
warning statements that meet the criteria of the Globally Harmonized
System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k). It is a significant new use to
manufacture the substances without sampling and analyzing the immediate
precursor used to manufacture the substances according to the terms
specified in the TSCA Order for the following elements: arsenic,
barium, beryllium, cadmium, chromium, cobalt, copper, lead, manganese,
mercury, nickel, selenium, silver, vanadium, and zinc. It is a
significant new use to manufacture the substances at facilities other
than those equipped with pollution controls, such as a bag house, that
remove particulates from the air at 99% or greater efficiency. It is a
significant new use to process the substances other than in an enclosed
system that does not allow for the release of particulates or at
facilities equipped with pollution controls, such as a bag house, that
remove particulates from the air at 99% or greater efficiency.
(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 (d) and (f) through (i) are applicable to
manufacturers, importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(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. 721.11698 Ashes (residues), reactions products with substituted
tricarboxylic acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-
(trialkoxysilyl)alkoxy]methyl] oxirane (generic) (P-20-113).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as ashes
(residues), reactions products with substituted tricarboxylic acid,
silicic acid (H4SiO4) tetra-Et ester and 2-[[3-
(trialkoxysilyl)alkoxy]methyl] oxirane (generic) (PMN P-20-113) 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 incorporated into a polymer matrix.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(4) through (6), (b), and (c). When determining which persons
are reasonably likely to be exposed as required for Sec. 721.63(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). For purposes of Sec. 721.63(b), the concentration is
set at 0.1%.
(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 Order for this substance. The NCEL is 0.05 mg/m\3\ as an 8-hour
time weighted average. Persons who wish to pursue NCELs as an
alternative to Sec. 721.63 respirator requirements may request to do
so under Sec. 721.30. Persons whose Sec. 721.30 requests to use the
NCEL approach are approved by EPA will be required to follow NCEL
provisions comparable to those contained in the corresponding TSCA
Order.
(B) [Reserved]
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1)(ii) through (ix), (g)(2) and (g)(5). For
purposes of Sec. 721.72(e),
[[Page 37800]]
the concentration is set at 0.1%. For purposes of Sec. 721.72(g)(2),
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 0.05 mg/m\3\; use skin
protection. Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k). It is a significant new use to
manufacture the substances without sampling and analyzing the immediate
precursor used to manufacture the substances according to the terms
specified in the TSCA Order for the following elements: arsenic,
barium, beryllium, cadmium, chromium, cobalt, copper, lead, manganese,
mercury, nickel, selenium, silver, vanadium, and zinc. It is a
significant new use to manufacture the substances at facilities other
than those equipped with pollution controls, such as a bag house, that
remove particulates from the air at 99% or greater efficiency. It is a
significant new use to process the substances other than in an enclosed
system that does not allow for the release of particulates or at
facilities equipped with pollution controls, such as a bag house, that
remove particulates from the air at 99% or greater efficiency.
(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 (d) and (f) through (i) are applicable to
manufacturers, importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(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. 721.11699 Ashes (residues), reactions products with
dicarboxylic acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-
(trialkoxysilyl)alkoxy]methyl]oxirane (generic) (P-20-114).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as ashes
(residues), reactions products with dicarboxylic acid, silicic acid
(H4SiO4) tetra-Et ester and 2-[[3-(trialkoxysilyl)alkoxy]methyl]oxirane
(generic) (PMN P-20-114) 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 incorporated into a polymer
matrix.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63 (a)(4) 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 50. 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 0.1%.
(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 Order for this substance. The NCEL is 0.05 mg/m\3\ as an 8-hour
time weighted average. Persons who wish to pursue NCELs as an
alternative to Sec. 721.63 respirator requirements may request to do
so under Sec. 721.30. Persons whose Sec. 721.30 requests to use the
NCEL approach are approved by EPA will be required to follow NCEL
provisions comparable to those contained in the corresponding TSCA
Order.
(B) [Reserved]
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1)(ii) through (ix), (g)(2) and (g)(5). For
purposes of Sec. 721.72(e), the concentration is set at 0.1%. For
purposes of Sec. 721.72(g)(2), 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 0.05 mg/m\3\; use skin protection. Alternative hazard and
warning statements that meet the criteria of the Globally Harmonized
System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k). It is a significant new use to
manufacture the substances without sampling and analyzing the immediate
precursor used to manufacture the substances according to the terms
specified in the TSCA Order for the following elements: arsenic,
barium, beryllium, cadmium, chromium, cobalt, copper, lead, manganese,
mercury, nickel, selenium, silver, vanadium, and zinc. It is a
significant new use to manufacture the substances at facilities other
than those equipped with pollution controls, such as a bag house, that
remove particulates from the air at 99% or greater efficiency. It is a
significant new use to process the substances other than in an enclosed
system that does not allow for the release of particulates or at
facilities equipped with pollution controls, such as a bag house, that
remove particulates from the air at 99% or greater efficiency.
(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 (d) and (f) through (i) are applicable to
manufacturers, importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(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. 721.11700 Ashes (residues), reactions products with substituted
tricarboxylic acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-
(trialkoxysilyl)alkoxy]methyl] oxirane (generic) (P-20-115).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as ashes
(residues), reactions products with substituted tricarboxylic acid,
silicic acid (H4SiO4) tetra-Et ester and 2-[[3-
(trialkoxysilyl)alkoxy]methyl] oxirane (generic) (PMN P-20-115) 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 incorporated into a polymer matrix.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(4) through (6), (b), and (c). When determining which persons
are reasonably likely to be exposed as required for Sec. 721.63(a)(4),
engineering control measures (e.g., enclosure or confinement of the
operation, general
[[Page 37801]]
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). For purposes of Sec. 721.63(b), the concentration is
set at 0.1%.
(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 Order for this substance. The NCEL is 0.05 mg/m\3\ as an 8-hour
time weighted average. Persons who wish to pursue NCELs as an
alternative to Sec. 721.63 respirator requirements may request to do
so under Sec. 721.30. Persons whose Sec. 721.30 requests to use the
NCEL approach are approved by EPA will be required to follow NCEL
provisions comparable to those contained in the corresponding TSCA
Order.
(B) [Reserved]
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1)(ii) through (ix), (g)(2) and (g)(5). For
purposes of Sec. 721.72(e), the concentration is set at 0.1%. For
purposes of Sec. 721.72(g)(2), 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 0.05 mg/m\3\; use skin protection. Alternative hazard and
warning statements that meet the criteria of the Globally Harmonized
System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k). It is a significant new use to
manufacture the substances without sampling and analyzing the immediate
precursor used to manufacture the substances according to the terms
specified in the TSCA Order for the following elements: arsenic,
barium, beryllium, cadmium, chromium, cobalt, copper, lead, manganese,
mercury, nickel, selenium, silver, vanadium, and zinc. It is a
significant new use to manufacture the substances at facilities other
than those equipped with pollution controls, such as a bag house, that
remove particulates from the air at 99% or greater efficiency. It is a
significant new use to process the substances other than in an enclosed
system that does not allow for the release of particulates or at
facilities equipped with pollution controls, such as a bag house, that
remove particulates from the air at 99% or greater efficiency.
(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 (d) and (f) through (i) are applicable to
manufacturers, importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(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. 721.11701 Ashes (residues), reactions products with
dicarboxylic acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-
(trialkoxysilyl)alkoxy]methyl]oxirane (generic) (P-20-116).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as ashes
(residues), reactions products with dicarboxylic acid, silicic acid
(H4SiO4) tetra-Et ester and 2-[[3-(trialkoxysilyl)alkoxy]methyl]oxirane
(generic) (PMN P-20-116) 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 incorporated into a polymer
matrix.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(4) through (6), (b), and (c). When determining which persons
are reasonably likely to be exposed as required for Sec. 721.63(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. For purposes of Sec. 721.63(b), the
concentration is set at 0.1%.
(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 Order for this substance. The NCEL is 0.05 mg/m\3\ as an 8-hour
time weighted average. Persons who wish to pursue NCELs as an
alternative to Sec. 721.63 respirator requirements may request to do
so under Sec. 721.30. Persons whose Sec. 721.30 requests to use the
NCEL approach are approved by EPA will be required to follow NCEL
provisions comparable to those contained in the corresponding TSCA
Order.
(B) [Reserved]
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1)(ii) through (ix), (g)(2) and (g)(5). For
purposes of Sec. 721.72(e), the concentration is set at 0.1%. For
purposes of Sec. 721.72(g)(2), 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 0.05 mg/m\3\; use skin protection. Alternative hazard and
warning statements that meet the criteria of the Globally Harmonized
System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k). It is a significant new use to
manufacture the substances without sampling and analyzing the immediate
precursor used to manufacture the substances according to the terms
specified in the TSCA Order for the following elements: arsenic,
barium, beryllium, cadmium, chromium, cobalt, copper, lead, manganese,
mercury, nickel, selenium, silver, vanadium, and zinc. It is a
significant new use to manufacture the substances at facilities other
than those equipped with pollution controls, such as a bag house, that
remove particulates from the air at 99% or greater efficiency. It is a
significant new use to process the substances other than in an enclosed
system that does not allow for the release of particulates or at
facilities equipped with pollution controls, such as a bag house, that
remove particulates from the air at 99% or greater efficiency.
(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 (d) and (f) through (i) are applicable to
manufacturers, importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The
[[Page 37802]]
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. 721.11702 Ashes (residues), reactions products with
dicarboxylic acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-
(trialkoxysilyl)alkoxy]methyl]oxirane (generic) (P-20-117).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as ashes
(residues), reactions products with dicarboxylic acid, silicic acid
(H4SiO4) tetra-Et ester and 2-[[3-(trialkoxysilyl)alkoxy]methyl]oxirane
(generic) (generic) (PMN P-20-117) 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
incorporated into a polymer matrix.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(4) through (6), (b), and (c). When determining which persons
are reasonably likely to be exposed as required for Sec. 721.63(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). For purposes of Sec. 721.63(b), the concentration is
set at 0.1%.
(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 Order for this substance. The NCEL is 0.05 mg/m\3\ as an 8-hour
time weighted average. Persons who wish to pursue NCELs as an
alternative to Sec. 721.63 respirator requirements may request to do
so under Sec. 721.30. Persons whose Sec. 721.30 requests to use the
NCEL approach are approved by EPA will be required to follow NCEL
provisions comparable to those contained in the corresponding TSCA
Order.
(B) [Reserved]
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1)(ii) through (ix), (g)(2) and (g)(5). For
purposes of Sec. 721.72(e), the concentration is set at 0.1%. For
purposes of Sec. 721.72(g)(2), 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 0.05 mg/m\3\; use skin protection. Alternative hazard and
warning statements that meet the criteria of the Globally Harmonized
System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k). It is a significant new use to
manufacture the substances without sampling and analyzing the immediate
precursor used to manufacture the substances according to the terms
specified in the TSCA Order for the following elements: arsenic,
barium, beryllium, cadmium, chromium, cobalt, copper, lead, manganese,
mercury, nickel, selenium, silver, vanadium, and zinc. It is a
significant new use to manufacture the substances at facilities other
than those equipped with pollution controls, such as a bag house, that
remove particulates from the air at 99% or greater efficiency. It is a
significant new use to process the substances other than in an enclosed
system that does not allow for the release of particulates or at
facilities equipped with pollution controls, such as a bag house, that
remove particulates from the air at 99% or greater efficiency.
(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 (d) and (f) through (i) are applicable to
manufacturers, importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(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. 721.11703 Silsesquioxanes, alkyl, alkoxy- and hydroxy-
terminated (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
silsesquioxanes, alkyl, alkoxy- and hydroxy- terminated (PMN P-20-173)
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), (b), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) and (a)(4), engineering control measures (e.g., enclosure
or confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. For purposes of Sec. 721.63(a)(5), respirators must
provide a National Institute for Occupational Safety and Health (NIOSH)
assigned protection factor (APF) of at least 10. For purposes of Sec.
721.63(b), the concentration is set at 1.0%. For purposes of Sec.
721.63(a)(6), the airborne form(s) of the substance include:
particulate (including solids or liquid droplets).
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(3), and (g)(5). For purposes of
Sec. 721.72(e), the concentration is set at 1.0%. For purposes of
Sec. 721.72(g)(1), this substance may cause: skin irritation; eye
irritation; serious eye damage; specific target organ toxicity. For
purposes of Sec. 721.72(g)(3), this substance may cause: aquatic
toxicity. Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) 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,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
[[Page 37803]]
Sec. 721.11704 1,3-Benzenedicarboxylic acid, polymer with 2,2-
dimethyl-1,3-propanediol, 1,2-ethanediol, 2-ethyl-2- (hydroxymethyl)-
1,3-propanediol, hexanedioic acid, 1,6-hexanediol and 1,3-
isobenzofurandione, N-[[1,3,3-trimethyl-5-[[[2-[(1-oxo-2- propen-1-
yl)oxy]ethoxy]carbonyl]amino]cyclohexyl]methyl]carbamate N-[3,3,5-
trimethyl-5-[[[[2-[(1-oxo-2-propen-1-
yl)oxy]ethoxy]carbonyl]amino]methyl]cyclohexyl]carbamate.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1,3-
benzenedicarboxylic acid, polymer with 2,2-dimethyl-1,3-propanediol,
1,2-ethanediol, 2-ethyl-2- (hydroxymethyl)-1,3-propanediol, hexanedioic
acid, 1,6-hexanediol and 1,3-isobenzofurandione, N-[[1,3,3-trimethyl-5-
[[[2-[(1-oxo-2- propen-1-
yl)oxy]ethoxy]carbonyl]amino]cyclohexyl]methyl]carbamate N-[3,3,5-
trimethyl-5-[[[[2-[(1-oxo-2-propen-1-
yl)oxy]ethoxy]carbonyl]amino]methyl]cyclohexyl]carbamate (PMN P-21-10;
CAS No. 2460376-09-2) 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
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
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), and (g)(5). For purposes of Sec.
721.72(g)(1), this substance may cause: skin irritation, eye
irritation, skin sensitization, and respiratory sensitization.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11705 Methyl phenylethyl cyclopropanemethanol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as methyl
phenylethyl cyclopropanemethanol (PMN P-21-13) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3) through (5), (a)(6)(v) and (vi), and (c). When
determining which persons are reasonably likely to be exposed as
required for Sec. 721.63(a)(1) and (a)(4), engineering control
measures (e.g., enclosure or confinement of the operation, general and
local ventilation) or administrative control measures (e.g., workplace
policies and procedures) shall be considered and implemented to prevent
exposure, where feasible. For purposes of Sec. 721.63(a)(5),
respirators must provide a National Institute for Occupational Safety
and Health (NIOSH) assigned protection factor (APF) of at least 50.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(3), and (g)(5). For purposes of
Sec. 721.72(g)(1), this substance may cause: eye irritation; skin
sensitization. For purposes of Sec. 721.72(g)(3), this substance may
be: toxic to aquatic life. Alternative hazard and warning statements
that meet the criteria of the Globally Harmonized System and OSHA
Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to use the substance in consumer products unless
the concentration of the substance is less than 1%.
(iv) 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 (i), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11706 [(Substituted-carbomonocyclic)amino] oxoalkenoic
acid, inorganic salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
[(substituted-carbomonocyclic)amino] oxoalkenoic acid, inorganic salt
(PMN P-21-17) 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 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).
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f) (g)(1), and (g)(5). For purposes of Sec.
721.72(g)(1), this substance may cause: skin 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) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f). It is a significant new use to use the
substance other than as an additive to improve physical properties in
rubber products.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
[[Page 37804]]
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11707 Sulfonium, triphenyl-, heterocyclic compound-
carboxylate (1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonium, triphenyl-, heterocyclic compound-carboxylate (1:1) (PMN P-
21-18) is subject to reporting under this section for the significant
new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substance after they have been completely reacted or adhered (during
photolithographic processes) onto a semiconductor wafer surface or
similar manufactured article used in the production of semiconductor
technologies.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) and (iii), (a)(3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii) and (v),
(g)(3)(i) and (ii), and (g)(5). For purposes of Sec. 721.72(e), the
concentration is set at 1%. For purposes of Sec. 721.72(g)(1), this
substance may cause: skin irritation; acute toxicity; skin
sensitization; serious eye damage; specific target organ toxicity;
neurotoxicity; genetic toxicity; reproductive toxicity. Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (k), and (t). It is a significant new
use to import the substance other than in solution, unless in sealed
containers weighing 5 kilograms or less. It is a significant new use to
process the substance in any way that generates dust, mist, or aerosol
in a non-enclosed process. It is a significant new use to manufacture
the substance longer than 18 months.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, 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. 721.11708 Sulfonium, carbocyclic-, salt with 1-(alkyl) 2-[4-
[polyhydro-2-carbomonocyclic-5-(polyfluoro-2-sulfoalkyl)-4,7-methano-
1,3-benzodioxol-2-yl]carbomonocyclic oxy]acetate (1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonium, carbocyclic-, salt with 1-(alkyl) 2-[4-[polyhydro-2-
carbomonocyclic-5-(polyfluoro-2-sulfoalkyl)-4,7-methano-1,3-
benzodioxol-2-yl]carbomonocyclic oxy]acetate (1:1) (PMN P-21-23) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the substance after they have
been completely reacted or adhered onto a semiconductor wafer surface
or similar manufactured article used in the production of semiconductor
technologies.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) and (iii), (a)(3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii) and (v),
(g)(3)(i) and (ii), and (g)(5). For purposes of Sec. 721.72(e), the
concentration is set at 1%. For purposes of Sec. 721.72(g)(1), this
substance may cause: skin irritation; acute toxicity; skin
sensitization; serious eye damage; specific target organ toxicity;
neurotoxicity; genetic toxicity; reproductive toxicity. Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (k), and (t). It is a significant new
use to import the substance other than in solution, unless in sealed
containers weighing 5 kilograms or less. It is a significant new use to
process the substance in any way that generates dust, mist, or aerosol
in a non-enclosed process. It is a significant new use to manufacture
the substance longer than 18 months.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, 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. 721.11709 Sulfonium, triphenyl-, polyfluoro-polyhydrospiro[9H-
carbopolycyclic-9,2'-[4,7]methano[1,3]benzodioxole]-5'-alkenesulfonic
acid (1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonium, triphenyl-, polyfluoro-polyhydrospiro[9H-carbopolycyclic-
9,2'-[4,7]methano[1,3]benzodioxole]-5'-alkenesulfonic acid (1:1) (PMN
P-21-64) is subject to reporting under this section for the significant
new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substance after they have been completely reacted or adhered onto a
semiconductor wafer surface or similar manufactured article used in the
production of semiconductor technologies.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) and (iii), (a)(3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
[[Page 37805]]
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii) and (v),
(g)(3)(i) and (ii), and (g)(5). For purposes of Sec. 721.72(e), the
concentration is set at 1%. For purposes of Sec. 721.72(g)(1), this
substance may cause: skin irritation; acute toxicity; skin
sensitization; serious eye damage; specific target organ toxicity;
neurotoxicity; genetic toxicity; reproductive toxicity. Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (k), and (t). It is a significant new
use to import the substance other than in solution, unless in sealed
containers weighing 5 kilograms or less. It is a significant new use to
process the substance in any way that generates dust, mist, or aerosol
in a non-enclosed process. It is a significant new use to manufacture
the substance longer than 18 months.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, 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. 721.11710 Heteropolycyclic, trihaloalkyl carbomonocycle-,
hydroxy carbomonocyclic salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
heteropolycyclic, trihaloalkyl carbomonocycle-, hydroxy carbomonocyclic
salt (PMN P-21-27) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substance after they have been completely reacted or adhered (during
photolithographic processes) onto a semiconductor wafer surface or
similar manufactured article used in the production of semiconductor
technologies.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) and (iii), (a)(3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii) and (v),
(g)(3)(i) and (ii), and (g)(5). For purposes of Sec. 721.72(e), the
concentration is set at 1%. For purposes of Sec. 721.72(g)(1), this
substance may cause: skin irritation; acute toxicity; skin
sensitization; serious eye damage; specific target organ toxicity;
neurotoxicity; genetic toxicity; reproductive toxicity. Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (k), and (t). It is a significant new
use to import the substance other than in solution, unless in sealed
containers weighing 5 kilograms or less. It is a significant new use to
process the substance in any way that generates dust, mist, or aerosol
in a non-enclosed process. It is a significant new use to manufacture
the substance longer than 18 months.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, 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. 721.11711 Sulfonium, tricarbocyclic-, 2-heteroatom-substituted-
4-(alkyl)carbomonocyclic carboxylate (1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonium, tricarbocyclic-,2-heteroatom-substituted-4-
(alkyl)carbomonocyclic carboxylate (1:1) (PMN P-21-42) 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 photolithographic processes) onto
a semiconductor wafer surface or similar manufactured article used in
the production of semiconductor technologies.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) and (iii), (a)(3), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii) and (v),
(g)(3)(i) and (ii), and (g)(5). For purposes of Sec. 721.72(e), the
concentration is set at 1%. For purposes of Sec. 721.72(g)(1), this
substance may cause: skin irritation; acute toxicity; skin
sensitization; serious eye damage; specific target organ toxicity;
neurotoxicity; genetic toxicity; reproductive toxicity. Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (k), and (t). It is a significant new
use to import the substance other than in solution, unless in sealed
containers weighing 5 kilograms or less. It is a significant new use to
process the substance in any way that generates dust, mist, or aerosol
in a non-enclosed process. It is a significant new use to manufacture
the substance longer than 18 months.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.
[[Page 37806]]
Sec. 721.11712 2-Propenoic acid, 2-methyl-, aminoalkyl ester,
polymer with hydroxyalkyl alkenoate and octadecyl alkenoate, acetate
(salts) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as 2-
propenoic acid, 2-methyl-, aminoalkyl ester, polymer with hydroxyalkyl
alkenoate and octadecyl alkenoate, acetate (salts) (PMN P-21-54) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the substance after they have
been incorporated into an article as defined at Sec. 720.3(c).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3), (b), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. For purposes of
Sec. 721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(3), and (g)(5). For purposes of
Sec. 721.72(e), the concentration is set at 1.0%. For purposes of
Sec. 721.72(g)(1), this substance may cause: skin irritation; eye
irritation; and specific target organ toxicity. For purposes of Sec.
721.72(g)(3), this substance may be: toxic to aquatic life. Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture or process the substance in any
manner that results in inhalation exposure. It is a significant new use
to use the substance in an application method that results in
inhalation exposure. It is a significant new use to use the substance
in a product that is applied by a consumer.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N=52. Before totaling the
releases of the substance to water from all operations at a site as
described in 40 CFR 721.91(a)(5), you may subtract up to 90 percent for
any releases that will be treated using primary and secondary
wastewater treatment as defined in 40 CFR part 133.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11713 Heterocyclic-polycarboxylic acid, polyhaloaryl-
polyhydro-alkyl-polyalkyl ester (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
heterocyclic-polycarboxylic acid, polyhaloaryl-polyhydro-alkyl-
polyalkyl ester (PMN P-21-63) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3), (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 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(3), and (g)(5). For purposes of
Sec. 721.72(e), the concentration is set at 1.0%. For purposes of
Sec. 721.72(g)(1), this substance may cause: skin irritation; acute
toxicity; reproductive toxicity; specific target organ toxicity. For
purposes of Sec. 721.72(g)(3), this substance may be: toxic to aquatic
life. Alternative hazard and warning statements that meet the criteria
of the Globally Harmonized System and OSHA Hazard Communication
Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o).
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11714 Alkenoic acid, reaction products with alkylamine-
alkanediyl diacrylate polymer and [oxybis(alkylene)]bis[alkyl-
alkanediol] salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkenoic acid, reaction products with alkylamine-alkanediyl diacrylate
polymer and [oxybis(alkylene)]bis[alkyl-alkanediol] (PMN P-21-65) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the substance after they have
been completely reacted (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 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) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), and (g)(5). For purposes of Sec.
721.72(g)(1), this substance may cause: skin irritation; eye
irritation; specific target organ toxicity. Alternative hazard and
warning statements that meet the criteria of the Globally Harmonized
System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to use the
substance in a spray application.
(b) Specific requirements. The provisions of subpart A of this part
[[Page 37807]]
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11715 Nonane, branched.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as nonane, branched
(PMN P-21-125; CAS No. 85408-10-2) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3) through (5), (a)(6)(v) and (vi), (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 50. For
purposes of Sec. 721.63(b), the concentration is set at 1.0%.
(A) As an alternative to the respirator requirements in paragraph
(a)(2)(i) of this section, a manufacturer or processor may choose to
follow the new chemical exposure limit (NCEL) provision listed in the
TSCA Order for this substance. The NCEL is 0.72 mg/m\3\ as an 8-hour
time weighted average. Persons who wish to pursue NCELs as an
alternative to Sec. 721.63 respirator requirements may request to do
so under Sec. 721.30. Persons whose Sec. 721.30 requests to use the
NCELs approach are approved by EPA will be required to follow NCELs
provisions comparable to those contained in the corresponding TSCA
Order.
(B) [Reserved]
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(3), and (g)(5). For purposes of
Sec. 721.72(e), the concentration is set at 1.0%. For purposes of
Sec. 721.72(g)(1), this substance may cause: skin irritation; eye
irritation; reproductive toxicity; specific target organ toxicity;
aspiration hazard. For purposes of Sec. 721.72(g)(3), this substance
may be: toxic to aquatic life. 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)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.
[FR Doc. 2022-13360 Filed 6-23-22; 8:45 am]
BILLING CODE 6560-50-P
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This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.