[Federal Register Volume 87, Number 178 (Thursday, September 15, 2022)]
[Proposed Rules]
[Pages 56610-56619]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-19023]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2020-0690; FRL-9864-01-OCSPP]
RIN 2070-AB27
Modification of Significant New Uses of Certain Chemical
Substances (21-1.M)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA is proposing to amend the significant new use rules
(SNURs) for certain chemical substances identified herein, which were
the subject of one or more premanufacture notices (PMNs) and in some
cases significant new use notices (SNUNs). This action would amend the
SNURs to allow certain new uses reported in the SNUNs or PMNs without
additional notification requirements and modify the significant new use
notification requirements based on the actions and determinations for
the SNUN or PMN submissions or based on the examination of new test
data or other information. EPA is proposing these amendments based on
our review of new and existing data for the chemical substances.
DATES: Comments must be received on or before October 17, 2022.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2020-0302, through the Federal eRulemaking
Portal at https://www.regulations.gov. Follow the online instructions
for submitting comments. Do not submit electronically any information
you consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Additional
instructions on commenting and visiting the docket, along with more
information about dockets generally, is available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: William Wysong, New Chemicals
Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001;
[[Page 56611]]
telephone number: (202) 564-4163; email address:
[email protected].
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you manufacture,
process, or use the chemical substances contained in this proposed
rule. The following list of North American Industrial Classification
System (NAICS) codes is not intended to be exhaustive, but rather
provides a guide to help readers determine whether this document
applies to them. Potentially affected entities may include:
Manufacturers or processors of the chemical substance
(NAICS codes 325 and 324110), e.g., chemical manufacturing and
petroleum refineries.
This proposed rule may affect certain entities through pre-existing
import certification and export notification rules under the Toxic
Substances Control Act (TSCA). Chemical importers are subject to the
TSCA section 13 (15 U.S.C. 2612) import certification requirements
promulgated at 19 CFR 12.118 through 12.127 and 19 CFR 127.28 and must
certify that the shipment of the chemical substance complies with all
applicable rules and orders under TSCA. Importers of chemicals subject
to a SNUR must certify their compliance with the SNUR requirements. Any
person who exports or intends to export the chemical substance that is
the subject of a final rule are subject to the export notification
provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) and 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 CBI information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.
II. Background
A. What action is the Agency taking?
EPA is proposing amendments to the SNURs for certain chemical
substances in 40 CFR part 721, subpart E. A SNUR for a chemical
substance designates certain activities as a significant new use.
Persons who intend to manufacture or process the chemical substance for
the significant new use must notify EPA at least 90 days before
commencing that activity. The required notification (i.e., a SNUN)
initiates EPA's evaluation of the intended use. Manufacture and
processing for the significant new use may not commence until EPA has
conducted a review of the notice, made an appropriate determination on
the notice, and taken such actions as are required in association with
that determination.
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 and may issue or modify a TSCA section 5(e) order and/
or amend the SNUR promulgated under TSCA section 5(a)(2). Procedures
and criteria for modifying or revoking SNUR requirements appear at 40
CFR 721.185.
III. Significant New Use Determination
TSCA section 5(a)(2) states that EPA's determination that a use of
a chemical substance is a significant new use must be made after
consideration of all relevant factors, including:
The projected volume of manufacturing and processing of a
chemical substance.
The extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical substance.
The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance.
The reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of a
chemical substance.
In determining whether and how to modify the significant new uses
for the chemical substances that are the subject of these SNURs, EPA
considered relevant information about the toxicity of the chemical
substance, likely human exposures and environmental releases associated
with possible uses, and the four TSCA section 5(a)(2) factors listed in
this unit.
IV. Substances Subject to Proposed Significant New Use Rule Amendments
and Proposed Changes
In this unit, EPA provides the following information for each
chemical substance subject to the proposed amendments presented in this
document:
CFR citation for the existing SNUR that EPA is proposing
to amend.
PMN and SNUN number(s), as applicable.
Chemical name (generic name, if the specific name is
claimed as CBI).
Chemical Abstracts Service (CAS) number (if assigned for
non-confidential chemical identities).
Final rule citation (Federal Register citation for the
final SNUR previously issued).
Basis for the proposed amendment.
Potentially Useful Information. This is information
identified by EPA that would help characterize the potential health
and/or environmental effects of the chemical substance in support of a
request by the PMN submitter to modify the TSCA 5(e) order, or if a
manufacturer or processor is considering submitting a SNUN for a
significant new use designated as such by the SNUR.
CFR citation: 40 CFR 721.5185.
PMN and SNUN numbers: P-95-169, S-08-7, S-14-1, S-17-10, and S-19-
0006.
Chemical name: 2-Propen-1-one, 1-(4-morpholinyl)-.
CAS number: 5117-12-4.
Final rule citations: 65 FR 354, January 5, 2000 (FRL-6055-2),
amended at 76 FR 27910, May 13, 2011 (FRL-8871-5), 80 FR 37161, June
30, 2015 (FRL-9928-93), and 85 FR 67996, October 27, 2020 (FRL-10013-
53).
Basis for the modified significant new use rule: P-95-169 describes
the intended use as a diluent for ultraviolet and electron beam curable
resins for coatings, inks, and curable adhesives, S-08-7 is for use in
energy production, S-14-1 is for use as a monomer in ultraviolet ink
jet applications, and S-17-10 is for use as a monomer for use in
stereolithography. On February 6, 2018, EPA issued an Order for S-17-10
[[Page 56612]]
under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a
determination that the use may present an unreasonable risk of injury
to human health and the environment. EPA identified concerns based on
acute toxicity, neurotoxicity, eye irritation, sensitization, liver
toxicity, and aquatic toxicity test data for the chemical substance. In
addition to the dermal protection, hazard communication, use, and water
release notification requirements under the previously published SNUR,
the Order for S-17-10 required respirators to prevent inhalation
exposure during the use of the chemical substance as a monomer in
stereolithography. The SNUR for this chemical substance was then
amended to remove the use described in SNUN S-17-10 from the scope of
the significant new use, except where that use does not include the
protective measures described in the Order for S-17-10.
On September 20, 2019, EPA received SNUN S-19-6 for the generic
(non-confidential) significant new use as a component for 3D printing
formulations. Based on available data on the chemical substance and
data on analogous chemicals, EPA identified the following human health
hazards: acute toxicity, skin and eye irritation, skin sensitization,
genotoxicity, carcinogenicity, and specific target organ toxicity.
Based on the activities described in the SNUN, EPA determined in
accordance with TSCA section 5(a)(3)(C) that the significant new use is
not likely to present an unreasonable risk of injury to health or the
environment under the conditions of use.
Pursuant to 40 CFR 721.185(a)(3), EPA determined that there is no
need to require additional notice from persons who propose to engage in
activities identical to those described in SNUN S-19-6. Accordingly,
the proposed amendment to the SNUR would remove use as a component for
3D printing formulations from the scope of the significant new use,
except where that use does not include the protective measures
described in the SNUR.
Potentially Useful Information: Certain information may be
potentially useful to characterize the health and environmental effects
of the chemical substance in support of a request to modify the Order,
or if a manufacturer or processor is considering submitting a SNUN for
a significant new use that would be designated by this proposed SNUR.
The results of specific organ toxicity, carcinogenicity, and aquatic
toxicity testing would help characterize the potential health and
environmental effects of the chemical substance.
CFR citation: 40 CFR 721.5192.
PMN and SNUN numbers: P-87-1036, S-06-5, and S-16-6.
Chemical name: Oxirane, 2,2'-[1,6-
naphthalenediylbis(oxymethylene)]bis-.
CAS number: 27610-48-6.
Final rule citation: 60 FR 45072, August 30, 1995 (FRL-4926-2).
Basis for the modified significant new use rule: P-87-1036
describes the generic intended use as a component for preparing polymer
composites, S-06-5 is for use as an adhesive additive, and S-16-6 is
for use as a resin. The Order for P-87-1036 was issued under sections
5(e)(1)(A)(i), (ii)(I) and (ii)(II) of TSCA based on a finding that the
chemical substance may present an unreasonable risk of injury to human
health and the environment and that the chemical substance will be
produced in substantial quantities and that it may reasonably be
anticipated to enter the environment in substantial quantities or there
may be significant or substantial human exposure. EPA issued a SNUR
designating significant new uses based on and consistent with the Order
requirements.
On March 24, 2006, EPA received SNUN S-06-05 for the generic (non-
confidential) significant new use as an adhesive additive. Based on the
activities described in the SNUN, EPA took no action and allowed the
significant new use. On December 9, 2015, EPA received SNUN S-16-6 for
the generic (non-confidential) significant new use as a resin and to
exceed the confidential aggregate production volume limit. Based on the
SNUN submitter's amendment to S-16-6 confirming its intention to abide
by the workplace protection, hazard communication, no domestic
manufacture, disposal by incineration or landfill, and release to water
restrictions in the SNUR, EPA did not determine the manufacturing,
processing, use, or disposal of this substance in the manner described
in S-16-6 may present an unreasonable risk to human health or the
environment. The decision not to regulate the SNUN substance was based
on limiting human exposure through the use of appropriate personal
protective equipment by exposed workers, hazard communication warnings,
import of the SNUN substance (i.e., no domestic manufacture), and
because the use described in the SNUN is not in consumer products. EPA
continues to have concerns for toxicity to human health where workers
are reasonably likely to be exposed. EPA also confirms that once the
SNUN substance is completely polymerized it will have been completely
reacted to form a different chemical substance and the SNUR does not
apply to that chemical substance.
Pursuant to 40 CFR 721.185(a)(3), EPA determined that there is no
need to require additional notice from persons who propose to engage in
activities identical to those described in S-06-05 and S-16-6.
Accordingly, the proposed amendment to the SNUR would remove the uses
described in both SNUNs from the scope of the significant new uses and
remove the aggregate production volume limit. It would also exempt SNUR
requirements when the substance has been completely reacted or cured.
The chemical substance which is the subject of this SNUR is now on the
public TSCA Inventory. Because of that EPA is proposing to amend the
SNUR to include the specific chemical name and CAS number.
Potentially Useful Information: Certain information may be
potentially useful to characterize the health and environmental effects
of the chemical substances if a manufacturer or processor is
considering submitting a SNUN for a significant new use that would be
designated as such by this proposed SNUR. The results of specific
target organ toxicity, carcinogenicity, and aquatic toxicity testing
would help characterize the potential health and environmental effects
of the chemical substance.
CFR citation: 40 CFR 721.7280.
PMN number: P-89-632.
Chemical name: 1,3-Propanediamine, N,N'-1,2-ethanediylbis-, polymer
with 2,4,6-trichloro-1,3,5-triazine, reaction products with N-butyl-
2,2,6,6-tetramethyl-4-piperidinamine.
CAS number: 136504-96-6.
Final rule citation: 55 FR 33296, August 15, 1990 (FRL-3741-8).
Basis for the modified significant new use rule: P-89-632 states
that the generic (non-confidential) intended use of the substance is as
light stabilizer for thermoplastics. Based on submitted test data, EPA
has concerns for immunotoxicity, effects on the liver, blood and
gastrointestinal tract, and reproductive toxicity and aquatic toxicity.
An Order was issued under TSCA sections 5(e)(1)(A)(i) and (ii)(I),
based on a finding that the substance may present an unreasonable risk
of injury to human health and the environment. EPA issued a SNUR
designating significant new uses based on and consistent with the Order
requirements.
EPA received a request from the PMN submitter to amend the Order
when the substance is completely bound in the polymer matrix. EPA
agreed that when
[[Page 56613]]
the PMN substance is completely bound in the polymer matrix, exposures
and risks are adequately mitigated. On January 27, 2010, EPA modified
the Order to add the exemption that the requirements of the Order do
not apply to quantities of the PMN substance after they have been
completely incorporated into the polymer matrix. For consistency with
the modified Order, the proposed amendment to the SNUR would similarly
exempt from the requirements of the SNUR quantities of the substance
after they have been completely incorporated into a polymer matrix. EPA
also received a request from the PMN submitter to revise the de minimus
concentration for exempt mixtures from 0.1% to 1% in worker protection
requirements in the SNUR to make it consistent with the Order. EPA is
proposing that change to the SNUR to be consistent with the terms of
the original Order. EPA is also proposing to add a de minimus
concentration exemption of 1% to the hazard communication requirements
in the SNUR to be consistent with the original Order.
Potentially Useful Information: Certain information may be
potentially useful to characterize the health and environmental effects
of the chemical substance if a manufacturer or processor is considering
submitting a SNUN for a significant new use that would be designated as
such by this proposed SNUR. The results of specific target organ
toxicity, reproductive toxicity, and aquatic toxicity testing would
help characterize the potential health and environmental effects of the
chemical substance.
CFR citation: 40 CFR 721.9502.
PMN and SNUN numbers: P-00-1132, S-03-15, and S-11-5.
Chemical name: Siloxanes and silicones, aminoalkyl, fluorooctyl,
hydroxy-terminated salt (generic).
CAS number: Not Available.
Final rule citations: 68 FR 15088, March 28, 2003 (FRL-6758-7),
amended at 80 FR 37165, June 30, 2015 (FRL-9924-10).
Basis for the modified significant new use rule: P-00-1132
describes the intended use of the chemical substance as use in anti-
graffiti systems; S-11-5 is for use as a surface treatment and additive
for coatings, adhesives, sealants, paste, insulation and textiles for
porous, non- porous, ceramic, metal, glass, plastic, wood and leather
surfaces; and a surface treatment agent for inorganic filler particles;
and S-03-15 is for use in anti-graffiti systems, and in surface
treatment of fabrics and porous mineral surfaces. The original SNUR for
P-00-1132 was issued based on meeting the concern criteria at 40 CFR
721.170(b)(3)(ii). The original SNUR required notification for use
other than as described in the PMN (graffiti systems) and for use
involving an application method that generates a vapor, mist, or
aerosol. On January 5, 2011, EPA received a SNUN, S-11-5, for the
chemical substance describing uses different than those in the PMN. EPA
also reviewed a 90-day inhalation study that was submitted for the
substance in the SNUN. The results of the study demonstrated a Lowest
Observed Adverse Effect Level (LOAEL) of 30 milligram/cubic meter (mg/
m3) for lung effects. The 90-day review period for the SNUN expired
with the Agency not taking action on the significant new uses described
in the SNUN. Because EPA continued to find that significant worker
exposure was unlikely when used as described in the PMN and SNUN, EPA
did not determine that the proposed manufacturing, processing, and use
of the substance may present an unreasonable risk. EPA did determine
that other uses of the substance or applications that generate a vapor,
mist, or aerosol could result in exposures which may cause serious
health effects. Based on this information the substance continued to
meet the concern criteria at 40 CFR 721(b)(3)(ii) and EPA modified the
SNUR on June 30, 2015, to remove the new uses identified in S-11-5 from
the scope of the significant new use but continued to require
notification for uses other than identified in P-00-1132 or S-11-5 and
for applications that generate a vapor, mist, or aerosol.
On June 30, 2003, EPA received SNUN S-03-15 for the chemical
substance describing uses different than those in the PMN including
uses that generate a vapor, mist, or aerosol. After review of this SNUN
was completed on August 30, 2017, EPA determined according to TSCA
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I) that the new uses may
present an unreasonable risk to human health and that an Order was
required to protect against those risks. The Order requires that the
substance is used only for anti-graffiti systems and surface treatment
of mineral porous systems, requires use of a NIOSH-approved respirator
with an APF of 100 for workers who are exposed by inhalation, allows as
an alternative to the respirators maintaining a New Chemicals Exposure
Limit (NCEL) of 0.03 mg/m\3\ as described in the Order, requires import
only (no manufacture in the United States), limits residuals and
impurities < 0.1%, does not allow consumer use, and requires hazard
communication for labels and SDSs. Based on the review of S-03-15 and
the provisions included in the Order, EPA is proposing a SNUR
modification to remove the notification requirement for use in
applications generating a vapor, mist, or aerosol, and to instead
designate as significant new uses the absence of protections required
in the Order for S-03-15 when use of the chemical substance may
generate a vapor, mist, aerosol.
Potentially Useful Information: Certain information may be
potentially useful to characterize the exposure and environmental fate
of the chemical substance if a manufacturer or processor is considering
submitting a SNUN for a significant new use that would be designated as
such by this proposed SNUR. The results of worker monitoring,
composition analysis, and decomposition testing would help characterize
the potential effects of the chemical substance.
CFR citation: 40 CFR 721.10395.
PMN numbers: P-10-458 and P-18-67.
Chemical name: Fatty acids, C14-18 and C16-18-unsatd., polymers
with adipic acid and triethanolamine, di-Me sulfate-quaternized.
CAS number: 1211825-32-9.
Final rule citation: 77 FR 25236, April 27, 2012 (FRL-9343-4).
Basis for the modified significant new use rule: On July 20, 2010,
EPA received P-10-458 describing the generic (non-confidential)
intended use of the substance as an adjuvant agent. Based on test data
on the PMN substance and EcoSAR analysis of test data on analogous
polycationic polymers, EPA predicted toxicity to aquatic organisms may
occur at concentrations that exceed 5 ppb of the PMN substance in
surface waters. As described in the PMN, releases of the substance are
not expected to result in surface water concentrations that exceed 5
ppb. Therefore, EPA did not determine that the proposed manufacturing,
processing, or use of the substance may present an unreasonable risk.
EPA determined that any use of the substance resulting in surface water
concentrations exceeding 5 ppb may cause significant adverse
environmental effects. Based on this information, EPA determined that
the PMN substance met the concern criteria at 40 CFR 721.170(b)(4)(i)
and (b)(4)(ii), and issued a SNUR requiring notification for release to
water from manufacturing, processing, or use resulting in a surface
water concentration exceeding 5 ppb.
On December 18, 2017, before a Notice of Commencement was submitted
that would add the substance to the TSCA Inventory, EPA received
[[Page 56614]]
PMN P-18-67 which identified the generic (non-confidential) intended
use of the substance as an adjuvant agent. Based on available data on
the new chemical substance and data on analogous chemicals, EPA
identified concerns for systemic and developmental effects. Based on
the activities described in the PMN, EPA determined in accordance with
TSCA section 5(a)(3)(C) that the PMN substance is not likely to present
an unreasonable risk of injury to health or the environment under the
conditions of use. The PMN submitter sent to EPA six ecotoxicity
studies to address the environmental toxicity concerns identified for
the SNUR. EPA evaluated the studies and determined that toxicity to
aquatic organisms may occur at concentrations that exceed 575 ppb
(i.e., acute concentration of concern) and 67 ppb (i.e., chronic
concentration of concern). The proposed amendment to the SNUR would
change the surface water concentration trigger for the significant new
uses from 5 ppb to 67 ppb based on the new concentrations of concern
determined by EPA.
Potentially Useful Information: EPA has determined that certain
information about the human health and environmental effects of the
SNUN substance may be potentially useful if a manufacturer or processor
is considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of skin
irritation, eye irritation, and specific target organ toxicity and
aquatic toxicity testing may be potentially useful to characterize the
human health and environmental effects of the SNUN substance.
CFR citation: 40 CFR 721.10996.
PMN numbers: P-15-310 and P-19-46.
Chemical name: 1,2,4-Benzenetricarboxylic acid, mixed decyl and
octyl triesters.
CAS number: 90218-76-1.
Final rule citation: 82 FR 48637, October 19, 2017 (FRL-9964-42).
Basis for the modified significant new use rule: PMN P-15-310
describes the intended use of the chemical substance as a lubricating
agent. The Order for P-15-310 was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I) based on a finding that the
chemical substance may present an unreasonable risk of injury to human
health and the environment. Based on test data, EPA identified concerns
for blood and adrenal gland effects to unprotected workers from
repeated dermal exposures. The Order requires the submitter of P-15-310
to not exceed the 2,440,000 kilograms aggregate production volume limit
without performing an Extended One-Generation Reproductive Toxicity
Study (OECD Test Guideline 443), worker dermal protection, hazard
communication requirements, not exceed an annual production volume of
150,000 kg, and refrain from using the chemical substance other than as
lubricant in chain oils for conveyor belts. EPA issued a SNUR
designating significant new uses based on and consistent with the Order
requirements.
On January 31, 2019, before a Notice of Commencement was submitted
that would add the substance to the TSCA Inventory, EPA received PMN P-
19-46 for the new chemical substance describing its intended use as a
lubricating agent. Based on submitted data on the new chemical
substance and data on analogous chemicals, EPA identified concerns for
blood, liver, maternal, and developmental toxicity. Based on the
activities described in the PMN, EPA determined in accordance with TSCA
section 5(a)(3)(C) that the PMN substance is not likely to present an
unreasonable risk of injury to health or the environment under the
conditions of use.
The proposed amendment to the SNUR would revise and replace certain
significant new uses to better tailor the SNUR to current risk concerns
following EPA's review and determination for P-19-46. The proposed
amendment would remove the significant new uses of annual production
volume greater than 150,000 kilograms and use other than as a lubricant
in chain oils for conveyor belts. EPA is proposing to remove these new
uses from the SNUR as these uses are no longer expected to result in
changes to human exposures or environmental releases that could result
in risk. In lieu of the removed uses, the proposed amendments would add
the significant new uses of release to water above 20,000 ppb and any
manufacture, processing, or use resulting in inhalation exposure. EPA
is proposing to designate these uses as significant new uses because
these uses could result in significant changes to human exposures or
environmental releases that could result in health risk.
Recommended Testing: EPA has determined that the results of certain
human health toxicity testing would help characterize the effects of
the PMN substance. The submitter of PMN P-15-310 has agreed not to
exceed the aggregate production volume limit without performing an
Extended One-Generation Reproductive Toxicity Study (OECD Test
Guideline 443).
CFR citation: 40 CFR 721.11005.
PMN numbers: P-16-309 and P-16-310.
Chemical name: 12-Hydroxystearic acid, reaction products with
alkylene diamine and alkanoic acid (generic).
CAS number: Not Available.
Final Rule citation: 82 FR 48637, October 19, 2017 (FRL-9964-42).
Basis for the modified significant new use rule: P-16-309 and P-16-
310 state that the generic (non-confidential) intended use of the
substances is as rheological or thixotropic agents used in the
production of solvent based industrial coatings, high solid aromatic
paints, adhesives, sealants, and other types of paints and topcoats.
Based on submitted test data, EPA predicted blood and hematology
effects. Further, based on SAR analysis of test data on analogous
amides, EPA predicted toxicity to aquatic organisms may occur at
concentrations that exceed 2 parts per billion (ppb) of the PMN
substances in surface waters. An Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that the
substances may present an unreasonable risk of injury to human health
and the environment. The submitter of P-16-309 and P-16-310 is subject
to the following Order requirements: no domestic manufacturing, no
manufacture beyond the confidential annual production volume limit, use
of the PMN substances only for the use specified in the Order,
compliance with the release to water provisions, and submission of
certain aquatic toxicity tests before exceeding a certain production
volume. EPA issued a SNUR designating significant new uses based on and
consistent with the Order requirements.
On September 28, 2018, the PMN submitter sent to EPA seven
ecotoxicity studies pursuant to the requirements of the Order. EPA
evaluated the studies and determined that toxicity to aquatic organisms
may occur at concentrations that exceed 13 ppb (i.e., acute
concentration of concern) and 4 ppb (i.e., chronic concentration of
concern). The PMN submitter also submitted an OECD 422 test guideline
combined repeated dose toxicity study with reproduction/developmental
toxicity screening test for P-16-310. EPA evaluated that study and
determined that the LOAEL of 100 mg/kg-bw/day is considered a low
hazard benchmark and the updated risk assessment for the PMN substances
did not demonstrate potential health risks. Based on the results of the
studies, EPA modified the Order to remove the annual production volume
limitation and change the water release limitation from 2 ppb to 4 ppb.
Consistent with the modification to the
[[Page 56615]]
Order, the proposed amendment to the SNUR would modify the significant
new use notification requirement to require notification for
manufacturing, processing, or use resulting in releases into surface
waters that exceed 4 ppb, instead of 2 ppb as provided in the original
SNUR. Because the company has submitted the required aquatic toxicity
studies and there will continue to be a release to water restriction
(i.e., water trigger), the proposed amendment to the SNUR would also
remove the significant new use notification requirement for exceeding
the aggregate and annual production volume limits, consistent with the
modification to the Order. Finally, EPA is proposing a clerical
amendment to the SNUR to remove an unnecessary cross-reference to the
procedures for determining whether a specific use is subject to the
SNUR; those procedures are not relevant to this SNUR because the
significant new uses described in the SNUR do not involve confidential
business information.
Potentially Useful Information: None.
CFR citation: 40 CFR 721.11227.
PMN numbers: P-16-271, P-16-450, and P-20-111.
Chemical name: 1,2,4-Benzenetricarboxylic acid, 1,2,4-trinonyl
ester.
CAS number: 35415-27-1.
Final Rule citation: 84 FR 66599, December 5, 2019 (FRL-10002-30).
Basis for the modified significant new use rule: The intended use
of the chemical substance described in P-16-271 and P-16-450 is as a
plasticizer in wire and cable insulation. EPA issued Orders for P-16-
271 and P-16-450 under sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I)
of TSCA based on a finding that the chemical substance may present an
unreasonable risk of injury to human health and the environment, and
sections 5(a)(3)(B)(ii)(II) and 5(e)(1)(A)(ii)(II) of TSCA based on a
finding that the chemical substance will be produced in substantial
quantities and that it may reasonably be anticipated to enter the
environment in substantial quantities or there may be significant or
substantial human exposure. Based on test data on other trimellitate
esters, EPA identified concerns for developmental and reproductive
toxicity. The Orders required the PMN submitters to submit to EPA
certain toxicity testing (Tier I testing) before manufacturing
(including import) a total of 1,750,000 kilograms of the PMN substance,
submit to EPA additional toxicity testing which will be determined upon
EPA review of the Tier I testing results, have workers wear dermal
protection, implement a hazard communication program, refrain from
manufacturing the PMN substance in the United States (i.e., import
only), and refrain from using the PMN substance other than as a
plasticizer in wire and cable insulation. EPA issued a SNUR designating
significant new uses based on and consistent with the Order
requirements.
On June 9, 2020, before a Notice of Commencement was submitted that
would add the substance to the TSCA Inventory, EPA received PMN P-20-
111 describing the generic (non-confidential) intended use as a
component in flexible automotive interior parts. Based on available
data on the new chemical substance and data on analogous chemicals, EPA
identified concerns for systemic and developmental effects. Based on
the activities described in PMN P-20-111, EPA determined in accordance
with TSCA section 5(a)(3)(C) that the PMN substance is not likely to
present an unreasonable risk of injury to health or the environment
under the conditions of use.
Based on EPA's review and determination for PMN P-20-111, the
proposed amendment would remove use as a component in flexible
automotive interior parts from the scope of the significant new use.
Based on the PMN submitter for P-20-111 identifying use of a NIOSH
certified respirator with an assigned protection factor of 10 and
hazard communication that includes hazards for eye irritation and
specific target organ toxicity, the proposed amendment would add
significant new uses for use without worker personal protective
equipment of a NIOSH certified respirator with an assigned protection
factor of 10 and hazard communication that does not include eye
irritation and specific target organ toxicity. The proposed significant
new use for specific target organ toxicity hazard communication would
replace the existing significant new use for internal organ effects
hazard communication to better harmonize the hazard communication
language with the Globally Harmonized System and OSHA Hazard
Communication Standard. EPA also proposes to remove the significant new
use requirement specified in 40 CFR 721.63(a)(2) as that was a
typographical error in the original SNUR.
Potentially Useful Information: Certain information may be
potentially useful to characterize the health effects of the chemical
substances if a manufacturer or processor is considering submitting a
SNUN for a significant new use that would be designated as such by this
proposed SNUR. The results of reproductive effects and specific target
organ toxicity testing would help characterize the potential health
effects of the chemical substance.
V. Rationale for the Proposed Rule
In those instances where EPA expanded the scope of the significant
new use, the Agency identified concerns, as discussed in Unit IV.,
associated with certain potential new uses. In addition to considering
the factors discussed in Unit IV., EPA determined that those uses could
result in changes in the type or form of exposure to the chemical
substance, increased exposures to the chemical substance, and/or
changes in the reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of
the chemical substance.
In those instances where EPA narrowed the scope of a significant
new use, EPA has (1) received significant new use or premanufacture
notices for some of the activities designated as significant new uses
of the substance and, after reviewing such notices, concluded that
there is no need to require additional notice from persons who propose
to engage in identical or similar activities; or (2) received test data
or other information that led the Agency to conclude that certain
activities designated as significant new uses are not likely to present
an unreasonable risk of injury to health or the environment. For the
SNUR for P-89-632 EPA is proposing changes to be consistent with the
Order (as modified) for that chemical substance.
VI. Applicability of the Proposed Rule to Uses Occurring Before
Effective Date of the Final Rule
To establish a significant new use, EPA must determine that the use
is not ongoing. EPA solicits comments on whether any of the uses that
are not currently a significant new use under the SNURs addressed in
this proposed rule, but which would be regulated as a ``significant new
use'' if this proposed rule is finalized, are ongoing. These specific
new uses are the additional requirements if a vapor, mist, or aerosol
is generated for the SNUR at 40 CFR 721.9502, use without worker
personal protective equipment of a NIOSH certified respirator with an
assigned protection factor of 10 and hazard communication that does not
include eye irritation and specific target organ toxicity for the SNUR
at 40 CFR 721.11227, and any manufacture, processing, or use that
results in inhalation exposure or water release
[[Page 56616]]
exceeding the surface water concentration limit for the SNUR at 40 CFR
721.10996.
EPA designates September 15, 2022, as the cutoff date for
determining whether the use is ongoing. EPA has decided that the intent
of TSCA section 5(a)(1)(B) is best served by designating a use as a
significant new use as of the date of public release of the proposed
SNUR rather than as of the effective date of the final rule. If uses
begun after public release were considered ongoing rather than new, it
would be difficult for EPA to establish SNUR notice requirements,
because a person could defeat the SNUR by initiating the proposed
significant new use before the rule became effective, and then argue
that the use was ongoing as of the effective date of the final rule.
Thus, any persons who begin commercial manufacture or processing
activities with the chemical substance that are not currently a
significant new use under the current rule but which would be regulated
as a ``significant new use'' if this proposed rule is finalized, must
cease any such activity as of the effective date of the rule if and
when finalized. To resume their activities, these persons would have to
comply with all applicable SNUR notice requirements and wait until the
notice review period, including all extensions, expires.
VII. Development and Submission of Information
TSCA section 5 generally 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, order, or
consent agreement under TSCA section 4 (15 U.S.C. 2603), then TSCA
section 5(b)(1)(A) (15 U.S.C. 2604(b)(1)(A)) requires such information
to be submitted to EPA at the time of submission of the SNUN.
In the absence of a rule, order, or consent agreement under TSCA
section 4 covering the chemical substance, persons are required only to
submit information in their possession or control and to describe any
other information known or reasonably ascertainable (40 CFR 720.50).
Unit IV. of this document lists potentially useful information for all
SNURs addressed in this proposed rule. Descriptions of this information
are provided for informational purposes. The potentially useful
information identified in Unit IV. will be useful to EPA's evaluation
of a chemical substance in the event that someone submits a SNUN for a
significant new use pursuant to the SNURs address in this proposed
rule. Companies who are considering submitting a SNUN are encouraged,
but are not required, to develop the potentially useful information on
the substance, which may assist with EPA's analysis of the SNUN.
EPA strongly encourages persons, before performing any testing, to
consult with the Agency. Furthermore, pursuant to TSCA section 4(h),
which pertains to reduction of testing on vertebrate animals, EPA
encourages dialogue 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 dialogue with Agency representatives to help determine how
best the submitter can meet both the data needs and the objective of
TSCA section 4(h).
The potentially useful information listed in Unit IV. may not be
the only means of providing information to evaluate the chemical
substance. EPA recommends that potential SNUN submitters contact EPA
early enough so that they will be able to conduct the appropriate
tests.
SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs which provide detailed information on the following:
human exposure and environmental release that may result from the
significant new use of the chemical substances; and 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 under 40 CFR part 720, 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 721.25 and 40 CFR 720.40. E-PMN
software is available electronically at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/filing-pre-manufacture-notice-epa.
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 rule. EPA's complete economic analysis is
available in the docket for this rulemaking.
X. Statutory and Executive Order Reviews
Additional information about these statutes and Executive Orders
can be found at https://www.epa.gov/laws-regulations-and-executive-orders.
A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulations and Regulatory Review
This action proposes to modify SNURs for chemical substances that
were the subject of PMNs and SNUNs. 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)
This action does not impose any new information collection burden
under the PRA (44 U.S.C. 3501 et seq.). Burden is defined in 5 CFR
1320.3(b). OMB has previously approved the information collection
activities contained in the existing regulations and has assigned OMB
control number 2070-0012 (EPA ICR No. 0574). This action does not
impose 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.
According to the PRA, 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.
C. Regulatory Flexibility Act (RFA)
I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA (5
U.S.C. 601 et seq.). The small entities subject to the requirements of
this action are small entities that would engage in the potential
manufacture and/or processing of the chemical substances for the
[[Page 56617]]
designated significant new uses covered by the proposed rule. The
requirement to submit a SNUN applies to any person (including small or
large entities) who intends to engage in any activity described in the
final rule as a ``significant new use.'' Because these uses are
``new,'' based on all information currently available to EPA, it
appears that no small or large entities presently engage in such
activities. A SNUR requires that any person who intends to engage in
such activity in the future must first notify EPA by submitting a SNUN.
EPA's experience to date is that, in response to the promulgation
of SNURs covering over 1,000 chemicals, the Agency receives only a
small number of notices per year. For example, the number of SNUNs
received was seven in Federal fiscal year (FY) 2013, 13 in FY2014, six
in FY2015, 10 in FY2016, 14 in FY2017, and 18 in FY2018 and only a
fraction of these were from small businesses. In addition, the Agency
currently offers relief to qualifying small businesses by reducing the
SNUN submission fee from $19,020 to $3,330. This lower fee reduces the
total reporting and recordkeeping of cost of submitting a SNUN to about
$11,164 for qualifying small firms. Therefore, the potential economic
impacts of complying with this proposed SNUR are not expected to be
significant or adversely impact a substantial number of small entities.
In a SNUR that published in the Federal Register of June 2, 1997 (62 FR
29684) (FRL-5597-1), the Agency presented its general determination
that 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)
This action does not contain any unfunded mandate as described in
UMRA (2 U.S.C. 1531-1538) and does not significantly or uniquely affect
small governments. The action imposes no enforceable duty on any state,
local or tribal governments. 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 rulemaking.
E. Executive Order 13132: Federalism
This action does not have federalism implications, as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999). It will not have
substantial direct effects on the 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.
F. Executive Order 13175: Consultation and Coordination With Indian
Tribe Governments
This action does not have tribal implications as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000). This action is
not expected to have substantial direct effects on Indian Tribes,
significantly nor uniquely affect the communities of Indian Tribal
governments and does not involve or impose any requirements that affect
Indian Tribes. Accordingly, the requirements of Executive Order 13175
do not apply to this proposed rule.
G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997),
as applying only to those regulatory actions that concern environmental
health or safety risks that the EPA has reason to believe may
disproportionately affect children, per the definition of ``covered
regulatory action'' in section 2-202 of the Executive Order. This
action is not subject to Executive Order 13045 because it does not
concern an environmental health risk or safety risk.
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
This action is not subject to Executive Order 13211 (66 FR 28355,
May 22, 2001), because this action is not expected to affect energy
supply, distribution, or use and because this action has not otherwise
been designated as a significant energy action by the Administrator of
the Office of Information and Regulatory Affairs.
I. National Technology Transfer and Advancement Act (NTTAA)
This action does not involve technical standards. As such, NTTAA
section 12(d), 15 U.S.C. 272 note, does not apply to this action.
J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations and
Executive Order 14008: Tackling the Climate Crisis at Home and Abroad
EPA believes that this action is not subject to Executive Order
12898 (59 FR 7629, February 16, 1994) and Executive Order 14008 (86 FR
7619, January 27, 2021) because it does not establish an environmental
health or safety standard.
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: August 29, 2022.
Tala Henry,
Deputy Director, Office of Pollution Prevention and Toxics.
Therefore, for the reasons set forth in the preamble, EPA proposes
to amend 40 CFR part 721 as follows:
PART 721--SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES
0
1. The authority citation for part 721 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
0
2. Amend Sec. 721.5185 by revising paragraphs (a)(1) and (a)(2)(i)(B)
and (iii) to read as follows:
Sec. 721.5185 2-Propen-1-one, 1-(4-morpholinyl)-.
(a) * * * (1) The chemical substance identified as 2-propen-1-one,
1-(4-morpholinyl)- (PMN P-95-169; SNUN S-08-7; SNUN S-14-1; SNUN S-17-
10; and SNUN S-19-6; CAS No. 5117-12-4) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section. The requirements of this rule do not apply to
quantities of the chemical substance after it has been completely
reacted (cured) because 2-propen-1-one, 1-(4-morpholinyl)- will no
longer exist.
(2) * * *
(i) * * *
(A) * * *
(B) Additional requirements for use as a monomer for
stereolithography and 3D printing: Requirements as specified in Sec.
721.63(a)(4) and (5), (a)(6)(v), 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
[[Page 56618]]
of Sec. 721.63(a)(5), respirators must provide a National Institute
for Occupational Safety and Health assigned protection factor of at
least 50.
* * * * *
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(y)(1). It is a significant new use to use
the chemical substance for any use other than as a monomer for use in
ultraviolet ink jet applications, stereolithography, or 3D printing,
unless the chemical substance is processed and used in an enclosed
process.
* * * * *
0
3. Amend Sec. 721.5192 by revising the section heading and paragraphs
(a)(1) and (a)(2)(iii) to read as follows:
Sec. 721.5192 Oxirane, 2,2'-[1,6-
naphthalenediylbis(oxymethylene)]bis-.
(a) * * * (1) The chemical substance identified as oxirane, 2,2'-
[1,6-naphthalenediylbis(oxymethylene)]bis- (PMN P-87-1036, SNUN S-06-5,
and SNUN S-16-6; CAS No. 27610-48-6) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section. The requirements of this rule do not apply to quantities
of the chemical substance after it has been completely reacted (cured).
* * * * *
(2) * * *
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f). It is a significant new use to use the
chemical substance other than for the confidential uses allowed in the
TSCA section 5(e) consent order for PMN P-87-1036 or the confidential
uses described in SNUNs S-06-5 and S-16-6.
* * * * *
0
4. Amend Sec. 721.7280 by revising paragraphs (a)(1) and (a)(2)(i) and
(ii) to read as follows:
Sec. 721.7280 1,3-Propanediamine, N,N'-1,2-ethanediylbis-, polymer
with 2,4,6-trichloro-1,3,5-triazine, reaction products with N-butyl-
2,2,6,6-tetramethyl-4-piperidinamine.
(a) * * * (1) The chemical substance identified as 1,3-
propanediamine, N,N'-1,2-ethanediylbis-, polymer with 2,4,6-trichloro-
1,3,5-triazine, reaction products with N-butyl-2,2,6,6-tetramethyl-4-
piperidinamine (PMN P-89-632; CAS No. 136504-96-6) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section. The requirements of this section do
not apply to quantities of the substance after they have been
completely incorporated into a polymer matrix.
(2) * * *
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(iii), (a)(3), (a)(4), (a)(5)(i), (a)(5)(ii),
(a)(5)(iv), (a)(5)(v), (a)(6)(i), (a)(6)(ii), (b), and (c). For
purposes of Sec. 721.63(b) the concentration is set at 1.0%.
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72(a) through (f), (g)(1)(iv), (g)(1)(viii), (g)(2)(i)
through (v), and (g)(5). For purposes of Sec. 721.72(e) the
concentration is set at 1.0%.
* * * * *
0
5. Amend Sec. 721.9502 by revising paragraphs (a)(1). (a)(2)(i) and
(ii), and (b)(1) to read as follows:
Sec. 721.9502 Siloxanes and silicones, aminoalkyl, fluorooctyl,
hydroxy-terminated salt (generic).
(a) * * * (1) The chemical substance identified generically as
siloxanes and silicones, aminoalkyl, fluorooctyl, hydroxy-terminated
salt (PMN P-00-1132, SNUN S-03-15, and SNUN S-11-5) is subject to
reporting under this section for the significant new use described in
paragraph (a)(2) of this section.
(2) * * *
(i) Industrial, commercial, and consumer activities. A significant
new use is any use of the chemical substance other than in graffiti
systems, as surface treatment and additive for coatings, adhesives,
sealants, paste, insulation and textiles for porous, non-porous,
ceramic, metal, glass, plastic, wood and leather surfaces, surface
treatment of fabrics and porous mineral surfaces, or a surface
treatment agent for inorganic filler particles.
(ii) Requirements if a vapor, mist or aerosol is generated. (A)
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 assigned protection factor of at least
1000. For purposes of Sec. 721.63(a)(6), the form is particulate. As
an alternative to the respiratory requirements listed here, a
manufacturer, importer, or processor may choose to follow the New
Chemical Exposure Limit (NCEL) provisions listed in the TSCA section
5(e) Order for these substances. The NCEL is 0.03 mg/m3 as an 8-hour
time weighted average verified by actual monitoring data. Persons who
wish to pursue NCELs as an alternative to Sec. 721.63 respirator
requirements may request to do so under Sec. 721.30. Persons whose
Sec. 721.30 requests to use the NCELs approach are approved by EPA
will be required to follow NCELs provisions comparable to those
contained in the corresponding TSCA section 5(e) Order.
(B) Hazard communication program. Requirements as specified in
Sec. 721.72(a) through (f), (g)(1)(ii), (g)(2)(ii), and (g)(5). For
purposes of Sec. 721.72(e) concentration is set at 1 percent.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
(C) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f) and (o). It is a significant new use to
manufacture the chemical substance if residuals or impurities are
greater than 0.1%.
(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.
* * * * *
0
6. Amend Sec. 721.10395 by revising paragraphs (a)(1) and (a)(2)(i) to
read as follows:
Sec. 721.10395 Fatty acids, C14-18 and C16-18-unsatd., polymers with
adipic acid and triethanolamine, di-Me sulfate-quaternized.
(a) * * * (1) The chemical substance identified as fatty acids,
C14-18 and C16-18-unsatd., polymers with adipic acid and
triethanolamine, di-Me sulfate-quaternized (PMNs P-10-458 and P-18-67;
CAS No. 1211825-32-9) is subject to reporting under this section for
the significant new use described in paragraph (a)(2) of this section.
(2) * * *
(i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=67.
* * * * *
0
7. Amend Sec. 721.10996 by revising paragraphs (a)(1), (a)(2)(ii), and
(b)(1), and adding paragraph (a)(2)(iv) to read as follows:
Sec. 721.10996 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl
triesters.
(a) * * * (1) The chemical substance identified as 1,2,4-
Benzenetricarboxylic acid, mixed decyl and octyl triesters (PMNs P-15-
310 and P-19-46; CAS No. 90218-76-1) is subject to reporting under this
section for the significant
[[Page 56619]]
new uses described in paragraph (a)(2) of this section.
(2) * * *
(ii) Industrial commercial, and consumer activities. Requirements
as specified in Sec. 721.80(p) (2,440,000 kilograms). It is a
significant new use to manufacture, process, or use the PMN substance
in any manner that results in inhalation exposure.
* * * * *
(iv) Releases to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N = 20,000 ppb.
(b) * * *
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (f), (i), and (k) are applicable to manufacturers
and processors of this substance.
* * * * *
0
8. Amend Sec. 721.11005 by revising paragraphs (a)(2)(i) and (ii) and
removing paragraph (b)(3) to read as follows:
Sec. 721.11005 12-Hydroxystearic acid, reaction products with
alkylene diamine and alkanoic acid (generic).
(a) * * * (1) The chemical substances identified as 12-
Hydroxystearic acid, reaction products with alkylene diamine and
alkanoic acid (generic) (PMNs P-16-309 and P-16-310) are subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) * * *
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f). It is a significant new use to use the
PMN substance other than as a rheological or thixotropic agent used in
the production of solvent based industrial coatings, high solid
aromatic paints, adhesives, sealants, and other types of paints and
topcoats.
(ii) Releases to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N = 4 ppb.
* * * * *
0
9. Amend Sec. 721.11227 by revising paragraphs (a)(1) and (2)(i)
through (iii) to read as follows:
Sec. 721.11227 1,2,4-Benzenetricarboxylic acid, 1,2,4-trinonyl ester.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1,2,4-
Benzenetricarboxylic acid, 1,2,4-trinonyl ester (PMNs P-16-271, P-16-
450, and P-20-111; CAS No. 35415-27-1) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section. The requirements of this section do not apply to
quantities of the substance after they have been incorporated into a
polymer matrix.
(2) * * *
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (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 (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 exposures,
where feasible. For purposes of Sec. 721.63(a)(5), respirators must
provide a National Institute for Occupational Safety and Health
assigned protection factor of at least 10. For purposes of Sec.
721.63(a)(6) the form is particulate. 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)(i), (vi) and (ix), (2)(i) and (v), and
(4)(i) through (iii) and (v). Alternative hazard and warning statements
that meet the criteria of the Globally Harmonized System and OSHA
Hazard Communication Standard may be used. For purposes of Sec.
721.72(e) the concentration is set at 1.0%. For purposes of Sec.
721.72(g)(1) this substance may cause eye irritation and specific
target organ toxicity.
(iii) Industrial commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f) and (p) (1,750,000 kilograms). It is a
significant new use to use the substance other than as a plasticizer in
wire and cable insulation and as a component in flexible automotive
interior parts.
* * * * *
[FR Doc. 2022-19023 Filed 9-14-22; 8:45 am]
BILLING CODE 6560-50-P