[Federal Register Volume 85, Number 86 (Monday, May 4, 2020)]
[Proposed Rules]
[Pages 26419-26438]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-08714]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2019-0596; FRL-10007-65]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances (20-
1.5e)
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 subject to Orders
issued by EPA pursuant 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 June 3, 2020.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2019-0596, by one of the following methods:
Federal eRulemaking Portal: http://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.
Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.
[[Page 26420]]
FOR FURTHER INFORMATION CONTACT: For technical information contact:
Kenneth Moss, Chemical Control Division (7405M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(202) 564-9232; email address: [email protected].
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you manufacture,
process, or use the chemical substances contained in this proposed
rule. The following list of North American Industrial Classification
System (NAICS) codes is not intended to be exhaustive, but rather
provides a guide to help readers determine whether this document
applies to them. Potentially affected entities may include:
Manufacturers or processors of one or more subject
chemical substances (NAICS codes 325 and 324110), e.g., chemical
manufacturing and petroleum refineries.
This action may also affect certain entities through pre-existing
import certification and export notification rules under TSCA. Chemical
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import
certification requirements 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. Importers of chemicals subject to final SNURs must certify
compliance with the SNUR requirements. The EPA policy in support of
import certification appears at 40 CFR part 707, subpart B. In
addition, any persons who export or intend to export a chemical
substance that is the subject of this proposed rule on or after June 3,
2020 are subject to the export notification provisions of TSCA section
12(b) (15 U.S.C. 2611(b)) (see 40 CFR 721.20), and must comply with the
export notification requirements in 40 CFR part 707, subpart D.
B. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.
II. Background
A. What action is the agency taking?
EPA is proposing these SNURs under TSCA section 5(a)(2) for
chemical substances that were the subject of PMNs. These proposed SNURs
would require persons to notify EPA at least 90 days before commencing
the manufacture or processing of a chemical substance for any activity
proposed as a significant new use. Receipt of such notices would allow
EPA to assess risks and, if appropriate, to regulate the significant
new use before it may occur. Additional background regarding SNURs is
more fully set out in the preamble to EPA's first direct final SNUR
published in the Federal Register issue of April 24, 1990 (55 FR
17376). Consult that preamble for further general information on the
objectives, rationale, and procedures for SNURs and on the basis for
significant new use designations, including provisions for developing
test data.
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. Once EPA determines that a use of a chemical
substance is a significant new use, TSCA section 5(a)(1)(B) requires
persons to submit a significant new use notice (SNUN) to EPA at least
90 days before they manufacture or process the chemical substance for
that use (15 U.S.C. 2604(a)(1)(B)(i)). TSCA furthermore prohibits such
manufacturing or processing from commencing until EPA has conducted a
review of the notice, made an appropriate determination, and taken such
actions as are required in association with that determination (15
U.S.C. 2604(a)(1)(B) ii)). In the case of a determination other than
not likely to present unreasonable risk, the applicable review period
must also expire before manufacturing or processing for the new use may
commence.
C. Applicability of General Provisions
General provisions for SNURs appear in 40 CFR part 721, subpart A.
These provisions describe persons subject to the proposed 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. According to 40 CFR 721.1(c), persons subject to these SNURs must
comply with the same 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 section 5(b)
and 5(d)(1), the exemptions authorized by TSCA section 5(h)(1), (h)(2),
(h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA
receives a SNUN, 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 before the manufacture or
processing for the significant new use can commence. In the case of a
determination other than not likely to present unreasonable risk, the
applicable review period must also expire before manufacturing or
processing for the new use may commence. If EPA determines that the use
is not likely to present an unreasonable risk, EPA is required under
TSCA section 5(g) to make public, and submit for publication in the
Federal Register, a statement of EPA's findings.
III. Significant New Use Determination
TSCA section 5(a)(2) states that EPA's determination that a use of
a chemical substance is a significant new use must be made after
consideration of all relevant factors, including:
The projected volume of manufacturing and processing of a
chemical substance.
The extent to which a use changes the type or form of
exposure of human
[[Page 26421]]
beings or the environment to a chemical substance.
The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance.
The reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of a
chemical substance.
In determining what would constitute a significant new use for the
chemical substances that are the subject of these SNURs, EPA considered
relevant information about the toxicity of the chemical substances,
likely human exposures and environmental releases associated with
possible uses, and the four TSCA section 5(a)(2) factors listed in this
unit. These 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). Those Orders require
protective measures to limit exposures or otherwise mitigate the
potential unreasonable risk. The proposed SNURs would 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 Orders, consistent with TSCA section 5(f)(4).
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:
PMN number.
Chemical name (generic name, if the specific name is
claimed as CBI).
Chemical Abstracts Service (CAS) Registry number (if
assigned for non-confidential chemical identities).
Effective date of and basis for the TSCA section 5(e)
Order.
Potentially Useful Information.
CFR citation assigned in the regulatory text section of
the proposed rule.
These 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). Those Orders require
protective measures to limit exposures or otherwise mitigate the
potential unreasonable risk. The proposed SNURs would 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 Orders, consistent with TSCA section 5(f)(4).
Where EPA determined that the PMN substance may present an
unreasonable risk of injury to human health via inhalation exposure,
the underlying TSCA section 5(e) 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),
include requirements addressing performance criteria for sampling and
analytical methods, periodic monitoring, respiratory protection, and
recordkeeping. No comparable NCEL provisions currently exist in 40 CFR
part 721, subpart B, for SNURs. Therefore, for these cases, the
individual SNURs in 40 CFR part 721, subpart E, will state that persons
subject to the SNUR who wish to pursue NCELs as an alternative to the
40 CFR 721.63 respirator requirements may request to do so under 40 CFR
721.30. EPA expects that persons whose 40 CFR 721.30 requests to use
the NCELs approach for SNURs that are approved by EPA will be required
to comply with NCELs provisions that are comparable to those contained
in the corresponding TSCA section 5(e) Order for the same chemical
substance.
The chemicals subject to these proposed SNURs are as follows:
PMN Number: P-14-865
Chemical Name: Aromatic amide oxime (generic).
CAS Number: Not available.
Effective date of TSCA section 5(e) Order: September 6, 2018.
Basis for TSCA section 5(e) Order: The PMN states that the generic
(non-confidential) use of the PMN substance will be as an intermediate.
EPA identified concerns for mutagenicity based on analysis of test data
on analogs. EPA also identified concerns for toxicity to fish based on
analysis of test data on the PMN substance. The Order was issued under
TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(I)(A)(ii)(I), based on a
finding that in the absence of sufficient information to permit a
reasoned evaluation the substance may present an unreasonable risk of
injury to human health and the environment. To protect against these
risks, the TSCA Order requires:
Use of personal protective equipment (where there is
potential for dermal exposure);
Use of the PMN substance only as a chemical intermediate;
and
No predictable or purposeful release of a manufacturing,
processing, or use stream associated with any use of the PMN substance
into the waters of the United States exceeding a surface water
concentration of 30 parts per billion (ppb).
The SNUR designates as a ``significant new use'' the absence of
these protective measures.
Potentially useful information: EPA has determined that certain
information may be potentially useful to characterize the effects of
the PMN substance in support of a request by the PMN submitter to
modify the Order, or if a manufacturer or processor is considering
submitting a SNUN for a significant new use that would be designated by
this SNUR. EPA has also determined that the results of specific
reproductive/developmental testing and chronic aquatic toxicity testing
would help characterize the potential human 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 relevant information.
CFR citation: 40 CFR 721.11466.
PMN Number: P-15-54
Chemical Name: Carbon nanotubes (generic).
CAS Number: Not available.
Effective Date of TSCA section 5(e) Order: December 17, 2019.
Basis for TSCA section 5(e) Order: The PMN states that the use of
the PMN substance will be as a chemical intermediate to manufacture
functionalized carbon nanotubes by oxidation with nitric acid; an
additive in rubber polymers to improve mechanical/physical/chemical/
electrical properties; an additive in resin polymers to improve
mechanical/physical/chemical/electrical properties; an additive in
metals to improve electrical/thermal properties; an additive in
ceramics to improve mechanical/electrical/thermal properties; a semi-
conductor, conductive, or resistive element in electronic circuitry and
devices; an electric collector element or electrode in energy devices;
a photoelectric or thermoelectric conversion elements in energy
devices; a catalyst support element or catalytic electrode for use in
energy devices; an additive for transparency and conductivity in
electronic devices; and an electro-mechanical element in actuator,
sensor, or switching devices. Based on carbon nanotube analogues, data
submitted for the PMN substance, and comparison to analogous
respirable, poorly soluble particulates, EPA identified concerns for
[[Page 26422]]
pulmonary toxicity and oncogenicity. A direct final SNUR was issued for
this PMN substance on November 17, 2016 (81 FR 81250), and withdrawn on
January 19, 2017 (82 FR 6277) in response to the PMN submitter's intent
to submit adverse comments, which was a request to modify the original
5(e) Order to add more uses. The Order (as modified) was issued under
TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a
finding that in the absence of sufficient information to permit a
reasoned evaluation the substance may present an unreasonable risk of
injury to human health and the environment. To protect against these
risks, the TSCA Order requires:
Use of personal protective equipment where there is a
potential for dermal exposure;
Use of a National Institute for Occupational Safety and
Health (NIOSH)-certified respirator with an Assigned Protection Factor
(APF) of at least 50 where there is a potential for inhalation
exposure;
Use of the PMN substance other than as allowed in the TSCA
Order;
Waste streams from manufacture, processing, and use must
be disposed of only by incineration or landfill; and
No predictable or purposeful release of a manufacturing,
processing, or use stream associated with any use of the PMN substance
into the waters of the United States.
The proposed SNUR would designate as a ``significant new use'' in
the absence of these protective measures.
Potentially useful information: EPA has determined that certain
information about the environmental effects of the PMN substance may be
potentially useful in support of a request by the PMN submitter to
modify the TSCA Order, or if a manufacturer or processor is considering
submitting a SNUN for a significant new use that would be designated by
this SNUR. EPA has determined that the results of chronic aquatic
toxicity testing, with NOM (natural organic matter) as the dispersant,
may be potentially useful to characterize the environmental effects of
the PMN substance. Although the TSCA Order does not require these
tests, the TSCA Order's restrictions remain in effect until the TSCA
Order is modified or revoked by EPA based on submission of this or
other relevant information.
CFR citation: 40 CFR 721.11467.
PMN Number: P-16-583
Chemical Name: Aromatic hydrocarbon resin (generic).
CAS Number: Not available.
Effective date of TSCA section 5(e) Order: October 17, 2018.
Basis for TSCA section 5(e) Order: The PMN states that the use of
the PMN substance will be as a sealant for head lamps of cars. EPA
identified concern for hydrocarbon pneumonia if the PMN substance is
manufactured with a higher proportion of lower molecular weight species
during heating. The Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(I)(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 TSCA Order requires:
Manufacture of the PMN substance such that the number
average molecular weight is at least 1,000 grams per mole; and
Use of the PMN substance only as a hot-melt sealant for
motor vehicle lamps.
The SNUR designates as a ``significant new use'' the absence of
these protective measures.
Potentially useful information: EPA has determined that certain
information about the health effects of the PMN substance may be
potentially useful in support of a request by the PMN submitter to
modify the TSCA Order, or if a manufacturer or processor is considering
submitting a SNUN for a significant new use that would be designated by
this SNUR. EPA has also determined that the results of specific organ
toxicity testing would help characterize the potential human health
effects of the PMN substance. Although the Order does not require these
tests, the TSCA Order's restrictions remain in effect until the TSCA
Order is modified or revoked by EPA based on submission of this or
relevant information.
CFR citation: 40 CFR 721.11468.
PMN Number: P-17-193
Chemical Names: Pentaerythritol ester of mixed linear and branched
carboxylic acids (generic) (P-17-193, chemical A) and Dipentaerythritol
ester of mixed linear and branched carboxylic acids (generic) (P-17-
193, chemical B).
CAS Numbers: Not available.
Effective Date of TSCA section 5(e) Order: January 8, 2020.
Basis for TSCA section 5(e) Order: The PMN states that the generic
(non-confidential) use of the PMN substances will be as a synthetic
lubricant for contained use and as an industrial lubricant. Based on
analogue data, EPA has identified concerns for reproductive/
developmental effects, systemic toxicity, and kidney effects. Based on
comparison to analogous esters, EPA predicts drinking water toxicity
may occur at concentrations that exceed 330 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 TSCA Order requires:
No predictable or purposeful release of a manufacturing,
processing, or use stream associated with any use of the PMN substances
into the waters of the United States exceeding a surface water
concentration of 330 ppb.
The proposed SNUR would designate as a ``significant new use'' in
the absence this protective measure.
Potentially Useful Information: EPA has determined that certain
information about the human health effects of the PMN substances may be
potentially useful in support of a request by the PMN submitter to
modify the TSCA Order, or if a manufacturer or processor is considering
submitting a SNUN for a significant new use that will be designated by
this SNUR. EPA has determined that the results of in vitro
toxicokinetics/metabolism information, specific target organ toxicity,
and reproductive/development toxicity testing may be potentially useful
to characterize the human health effects of the PMN substances.
Although the TSCA Order does not require these tests, the TSCA Order's
restrictions remain in effect until the TSCA Order is modified or
revoked by EPA based on submission of this or other relevant
information.
CFR citations: 40 CFR 721.11469 (P-17-193, chemical A) and 40 CFR
721.11470 (P-17-193, chemical B).
PMN Number: P-17-221
Chemical name: Alkylheterocyclic amine blocked isocyanate,
alkoxysilane polymer (generic).
CAS number: Not available.
Effective date of TSCA section 5(e) Order: October 17, 2018.
Basis for TSCA section 5(e) Order: The PMN states that the generic
(non-confidential) use of the PMN substance will be as a coating
polymer. Based on analysis of test data on reactivity of the methoxy
and ethoxy silane moieties as well as the release of methanol, EPA
identified concerns for ocular toxicity, irritation to eyes, skin,
lung, and mucous membranes. The TSCA Order was issued under TSCA
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding
that the in the absence of sufficient information to permit a reasoned
evaluation the substance may present an unreasonable risk of injury to
human health and the
[[Page 26423]]
environment. To protect against these risks, the TSCA Order requires:
Use of personal protective equipment including chemically
impervious gloves and eye goggles, (where there is potential for dermal
exposure);
No use of the PMN substance at a concentration greater
than 10% in formulation;
Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the Safety Data Sheet (SDS); and
Use of the PMN substance only for the confidential use
allowed in the TSCA Order.
The 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 health effects of the PMN substance may be
potentially useful in support of a request by the PMN submitter to
modify the TSCA Order, or if a manufacturer or processor is considering
submitting a SNUN for a significant new use that would be designated by
this SNUR. EPA has also determined that the results of specific
irritation and lung effect testing would help characterize the
potential human effects of the PMN substance. Although the TSCA Order
does not require these tests, the TSCA Order's restrictions remain in
effect until the TSCA Order is modified or revoked by EPA based on
submission of this or relevant information.
CFR citation: 40 CFR 721.11471.
PMN Number: P-17-282
Chemical Name: Isocyanic acid, polymethylenepolyphenylene ester,
caprolactam- and phenol-blocked.
CAS Number: 2093945-13-0.
Effective Date of TSCA section 5(e) Order: January 13, 2020.
Basis for TSCA section 5(e) Order: The PMN states that the use of
the PMN substance will be as a blocked crosslinker for electrical
insulation coating used on stators and motors. Based on the release of
phenol, EPA has identified concerns for irritation to membranes, blood
toxicity, and developmental toxicity. Based on the release of
caprolactam, EPA has also identified concerns for eye, skin, and
respiratory irritation, skin and respiratory sensitization, lung
effects, kidney toxicity, and developmental toxicity. Based on
comparison to analogous carbamate esters-phenyl and carbonyl ureas, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 1 ppb. The TSCA Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the
absence of sufficient information to permit a reasoned evaluation the
substance may present an unreasonable risk of injury to human health
and the environment. To protect against these risks, the TSCA Order
requires:
No modification of the manufacture, processing, or use of
the PMN substance in any manner that generates inhalation exposure to
phenol or caprolactam; and
No predictable or purposeful release of a manufacturing,
processing, or use stream associated with any use of the PMN substance
into the waters of the United States exceeding a surface water
concentration of 1 ppb.
The proposed SNUR would designate as a ``significant new use'' in
the absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information about the human health and environmental effects of the PMN
substance may be potentially useful in support of a request by the PMN
submitter to modify the TSCA Order, or if a manufacturer or processor
is considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of aquatic
toxicity, developmental toxicity, pulmonary effects, eye damage, skin
irritation/corrosion, and skin sensitization testing may be potentially
useful to characterize the human health and environmental effects of
the PMN substance. Although the Order does not require these tests, the
TSCA Order's restrictions remain in effect until the TSCA Order is
modified or revoked by EPA based on submission of this or other
relevant information.
CFR citation: 40 CFR 721.11472.
PMN Number: P-17-334
Chemical Name: Benzamide, 2-(trifluoromethyl)-.
CAS Number: 360-64-5.
Effective date of TSCA section 5(e) Order: August 20, 2018.
Basis for TSCA section 5(e) Order: The PMN states that the generic
(non-confidential) use of the PMN substance will be as a chemical
precursor. EPA has identified concerns for neurotoxic effects based on
analog data. There are concerns for oncogenicity based on test data. To
the extent the chemical substance is metabolized, there are concerns
for reproductive, developmental and neurotoxicity, lung, neurotoxicity,
liver, and kidney effects based on analog data for the potential
derivative metabolite. Based on analogous amides, EPA predicts
environmental effects may occur at surface water concentrations that
exceed 39 parts per billion. The TSCA Order was issued under TSCA
sections 5(a)(3)(B)(ii)(I) based on a finding that the substances may
present an unreasonable risk of injury to human health or the
environment. To protect against these risks, the TSCA Order requires:
No domestic manufacture of the PMN substance;
Use of personal protective equipment (where there is
potential for dermal exposure); Establishment and use of a hazard
communication program, including human health precautionary statements
on each label and in the SDS;
Import for processing and use only as a chemical
intermediate, as required by the Order, with no alteration of processes
that result in the generation of a dust, mist or aerosol; and
No predictable or purposeful release of a manufacturing,
processing, or use stream associated with any use of the PMN substance
into the waters of the United States exceeding a surface water
concentration of 39 ppb.
The 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 health and environmental effects of the PMN
substance may be potentially useful in support of a request by the PMN
submitter to modify the TSCA Order, or if a manufacturer or processor
is considering submitting a SNUN for a significant new use that would
be designated by this SNUR. EPA has also determined that the results of
specific absorption and metabolism testing and chronic aquatic toxicity
testing would help characterize the potential human and environmental
effects of the PMN substance. Although the TSCA Order does not require
these tests, the TSCA Order's restrictions remain in effect until the
TSCA Order is modified or revoked by EPA based on submission of this or
relevant information.
CFR citation: 40 CFR 721.11473.
PMN Number: P-17-386
Chemical Name: Cashew, nutshell liq. polymer with formaldehyde,
phenol and resorcinol.
CAS Number: 2044014-81-3.
Effective date of TSCA section 5(e) Order: October 19, 2018.
Basis for TSCA section 5(e) Order: The PMN states that the use of
the substance will be as an additive as a processing aid for automotive
tire stock
[[Page 26424]]
(tackifier for synthetic automotive tire stock). EPA identified
concerns for sensitization based on resorcinol and cashew nutshell oil.
The TSCA Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and
5(e)(I)(A)(ii)(I), based on a finding that in the absence of sufficient
information to permit a reasoned evaluation the substance may present
an unreasonable risk of injury to human health. The TSCA Order was also
issued under TSCA sections 5(a)(3)(B)(ii)(II) and 5(e)(1)(A)(ii)(II),
based on a finding that the substance is or will be produced in
substantial quantities and that the substance either enters or may
reasonably be anticipated to enter the environment in substantial
quantities, or there is or may be significant (or substantial) human
exposure to the substance. To protect against these risks, the TSCA
Order requires:
Submission to EPA of certain toxicity testing within 12
months of submission of a Notice of Commencement or Manufacture or
Import (NOC) for the PMN substance;
Use of personal protective equipment (where there is
potential for dermal exposure);
Use of a NIOSH-certified respirator with an APF of at
least 50 (where there is a potential for inhalation exposure); and
No use of the PMN substance in a consumer product.
The SNUR designates as a ``significant new use'' the absence of
these protective measures.
Potentially useful information: EPA has determined that certain
information about the 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 would be designated by
this SNUR. EPA has also determined that the results of specific
sensitization testing would help characterize the potential human
effects of the PMN substance. The submitter has agreed not to exceed a
certain production volume limit without performing an acute aquatic
toxicity testing. Although the TSCA Order does not require these tests,
the TSCA Order's restrictions remain in effect until the TSCA Order is
modified or revoked by EPA based on submission of this or relevant
information.
CFR citation: 40 CFR 721.11474.
PMN Number: P-18-12
Chemical Name: Polyester polyol (generic).
CAS Number: Not available.
Effective Date of TSCA section 5(e) Order: January 30, 2020.
Basis for TSCA section 5(e) Order: The PMN states that the generic
(non-confidential) use will be as adhesives. Based on the chelation of
calcium to form calculi, EPA has identified concern for bladder
toxicity. Based on comparison to analogous esters, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed 1
ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient
information to permit a reasoned evaluation, the substance may present
an unreasonable risk of injury to human health or the environment. To
protect against these risks, the TSCA Order requires:
No predictable or purposeful release of a manufacturing,
processing, or use stream associated with any use of the PMN substance
into the waters of the United States exceeding a surface water
concentration of 1 ppb.
The proposed SNUR would designate as a ``significant new use'' in
the absence of this protective measure.
Potentially Useful Information: EPA has determined that certain
information about the human health and environmental 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. EPA has determined that the results of acute
ecotoxicity base set, chronic ecotoxicity base set, and specific target
organ toxicity testing may be potentially useful to characterize the
human health and environmental effects of the PMN substance. Although
the TSCA Order does not require these tests, the TSCA Order's
restrictions remain in effect until the TSCA Order is modified or
revoked by EPA based on submission of this or other relevant
information.
CFR citation: 40 CFR 721.11475.
PMN Number: P-18-18
Chemical Name: Fluorinated acrylate, polymer with alkyloxirane
homopolymer monoether with alkanediol mono(2-methyl-2-propenoate),
tert-Bu 2-ethylhexaneperoxoate-initiated (generic).
CAS Number: Not available.
Effective date of TSCA section 5(e) Order: October 3, 2019.
Basis for TSCA section 5(e) Order: The PMN states that the generic
(non-confidential) use of the PMN substance will be as a lubricant.
Based on estimated physical/chemical properties of the PMN substance,
comparison to structurally analogous chemical substances, and
structural alerts for perfluoro compounds, EPA has identified lung
effects and systemic effects. Based on structural alerts for peroxides
and acrylates, EPA has also identified skin 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 specific information to
permit a reasoned evaluation the substance may present an unreasonable
risk of injury to human health or the environment. To protect against
these risks, the TSCA Order requires:
No manufacture (including import) of the PMN substance
beyond the confidential annual production volume;
Refrain from domestic manufacture of the PMN substance
(i.e., import only);
Refrain from manufacturing, processing, distributing in
commerce or using the PMN substance in a manner that would result in
the generation of respirable forms (i.e., mist, vapor, or aerosol); and
No predictable or purposeful release of a manufacturing,
processing, or use stream associated with any use of the PMN substance
into the waters of the United States.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information may be potentially useful to characterize the human health
effects of the PMN substance in support of a request by the PMN
submitter to modify the TSCA Order, or if a manufacturer or processor
is considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of skin
sensitization and specific target organ toxicity testing would help
characterize the potential health effects of the PMN substance.
Although the TSCA Order does not require these tests, the TSCA Order's
restrictions remain in effect until the TSCA Order is modified or
revoked by EPA based on submission of this or relevant information.
CFR citation: 40 CFR 721.11476.
PMN Number: P-18-42
Chemical name: 2,5-Furandione, polymer with 2-ethyl-2-
(hydroxymethyl)-1,3-propanediol, 3a,4,5,6,7,7a-hexahydro-4,7-methano-
1H-inden-5(or 6)-yl ester, ester with 2,3-dihydroxypropyl neodecanoate,
polymer with 5-isocyanato-1-(isocyanatomethyl)-1,3,3-
trimethylcyclohexane, 2-hydroxyethyl
[[Page 26425]]
acrylate- and 2-hydroxyethyl methacrylate-blocked.
CAS number: 2245262-16-0.
Effective date of TSCA section 5(e) Order: September 19, 2018.
Basis for TSCA section 5(e) Order: The PMN states that the generic
(non-confidential) use of the PMN substance will be as an industrial
coating. Based on analysis of test data on analogous acrylates, EPA
identified concerns for mutagenicity, oncogenicity, developmental
toxicity, liver toxicity, kidney toxicity, sensitization, and
irritation. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I)
based on a finding that the substances may present an unreasonable risk
of injury to human health or the environment. To protect against these
risks, the TSCA Order requires:
Use of personal protective equipment (where there is
potential for dermal exposure);
No use of the PMN substance involving an application
method that generates a dust, mist, spray or aerosol;
Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS;
Use of the PMN substance only for the confidential use
allowed in the TSCA Order; and
No use of the PMN substance in a consumer product.
The 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 health effects of the PMN substance may be
potentially useful in support of a request by the PMN submitter to
modify the TSCA Order, or if a manufacturer or processor is considering
submitting a SNUN for a significant new use that would be designated by
this SNUR. EPA has also determined that the results of specific
sensitization and developmental toxicity testing would help
characterize the potential human effects of the PMN substance. Although
the TSCA Order does not require these tests, the TSCA Order's
restrictions remain in effect until the TSCA Order is modified or
revoked by EPA based on submission of this or relevant information.
CFR citation: 40 CFR 721.11477.
PMN Numbers: P-18-52 and P-18-53
Chemical Names: Perfluoroalkyl ethyl- and vinyl-modified
organopolysiloxane (generic).
CAS Numbers: Not available.
Effective date of TSCA section 5(e) Order: January 14, 2020.
Basis for TSCA section 5(e) Order: The PMNs state that the generic
(non-confidential) use of the PMN substances will be as coating agents.
Based on high molecular weight insoluble polymers and polymers with
perfluorinated tails, EPA has identified concern for lung effects (lung
waterproofing and lung overload). Based on analogue data for the low
molecular weight fraction, EPA has also identified concerns for
thyroid, liver, and 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 and the environment. To protect against these
risks, the TSCA Order requires:
Use of personal protective equipment to prevent dermal
exposure where there is a potential for dermal exposure;
Use of a NIOSH-certified respirator with an APF of at
least 1,000 where there is a potential for inhalation exposure or
compliance with a NCEL of 0.0015 mg/m\3\ as an 8-hour time-weighted
average (TWA) to prevent inhalation exposure;
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS;
No domestic manufacture of the PMN substances (i.e.,
import only);
No import of the PMN substances beyond the annual
production volumes of 420 kg for P-18-52 and 336 kg for P-18-53; and
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information about the human health effects of the PMN substances may be
potentially useful in support of a request by the PMN submitter to
modify the TSCA Order, or if a manufacturer or processor is considering
submitting a SNUN for a significant new use that would be designated by
this SNUR. EPA has determined that the results of specific target organ
toxicity, pulmonary effects, and reproductive toxicity testing may be
potentially useful to characterize the human health effects of the PMN
substances. Although the TSCA Order does not require these tests, the
TSCA Order's restrictions remain in effect until the TSCA Order is
modified or revoked by EPA based on submission of this or other
relevant information.
CFR citations: 40 CFR 721.11478 (P-18-52) and 40 CFR 721.11479 (P-
18-53).
PMN Number: P-18-62
Chemical Name: Oxirane, 2,2'-[cyclohexylidenebis(4,1-
phenyleneoxymethylene)]bis-.
CAS Number: 13446-84-9.
Effective Date of TSCA section 5(e) Order: January 29, 2020.
Basis for TSCA section 5(e) Order: The PMN states that the generic
(non-confidential) use will be for open, non-dispersive use in coatings
specifically for the electronics fields. Based on structural alerts for
epoxides, EPA has identified concerns for carcinogenicity and
reproductive effects. Based on submitted test data on the PMN substance
and comparison to structurally analogous chemical substances, EPA has
also identified concerns for mutagenicity and kidney effects. Based on
QSAR predictions for analogous epoxides and neutral organics, EPA also
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 1 ppb. The Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the
absence of sufficient information to permit a reasoned evaluation, the
substance may present an unreasonable risk of injury to human health or
the environment. To protect against these ricks, the TSCA Order
requires:
Use of personal protective equipment to prevent dermal
exposure where there is a potential for dermal exposure;
Use of a NIOSH-certified respirator with an APF of at
least 1,000 where there is a potential for inhalation exposure;
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS;
No manufacture or processing of the PMN substance in any
manner which generates inhalation exposures;
No use of the PMN substance other than as described in the
PMN; and
No predictable or purposeful release of a manufacturing,
processing, or use stream associated with any use of the PMN substance
into the waters of the United States exceeding a surface water
concentration of 1 ppb.
The proposed SNUR would designate as a ``significant new use'' in
the absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information about the human health and environmental effects of the PMN
substance may be potentially useful in support of a request by the PMN
submitter to modify the TSCA Order, or if a manufacturer or processor
is
[[Page 26426]]
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, specific target organ toxicity, reproductive toxicity, and
carcinogenicity testing may be potentially useful to characterize the
human health and environmental effects of the PMN substance. Although
the TSCA Order does not require these tests, the TSCA Order's
restrictions remain in effect until the TSCA Order is modified or
revoked by EPA based on submission of this or other relevant
information.
CFR citation: 40 CFR 721.11480.
PMN Numbers: P-18-74 and P-18-75
Chemical Names: Saturated fatty acid, reaction products with
cadmium zinc selenide sulfide and polymeric amine (generic) (P-18-74)
and Saturated fatty acid, reaction products with cadmium zinc selenide
sulfide, alkylamine and polymeric amine (generic) (P-18-75).
CAS Numbers: Not available.
Effective Date of TSCA section 5(e) Order: January 31, 2020.
Basis for TSCA section 5(e) Order: The PMN for P-18-74 states that
use will be as a chemical intermediate for a quantum dot used as an
optical down-converter (50%), and quantum dot in an optical down-
converter (50%). The PMN for P-18-75 states that use will be as a
quantum dot used in an optical down-converter. Based on the physical/
chemical properties of the PMN substances and comparison to
structurally analogous chemical substances, EPA has identified concerns
for carcinogenicity, immunotoxicity, lung effects, dermal, ocular and
respiratory irritation, and undesignated 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 or the environment. To
protect against these risks, the TSCA Order requires:
No manufacture of the PMN substances with a cadmium
percentage greater than the confidential value stated in the Order;
No use of the PMN substance P-18-74 other than as a
chemical intermediate for a quantum dot used as an optical down-
converter or as a quantum dot in an optical down-converter;
No use of the PMN substance P-18-75 other than as a
quantum dot used in an optical down-converter;
No manufacture, processing, or use of the PMN substances
in any manner which results in inhalation exposure;
Manufacture, process, or use the PMN substances only in
liquid formulation;
Only dispose of the PMN substances by incineration in a
permitted hazardous waste incinerator;
No predictable or purposeful release of a manufacturing,
processing, or use stream associated with any use of the PMN substance
into the waters of the United States;
Use of dermal personal protective equipment where there is
a potential for dermal exposure; and
Establishment and use 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'' in
the absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information about the human health and environmental effects of the PMN
substances may be potentially useful in support of a request by the PMN
submitter to modify the TSCA Order, or if a manufacturer or processor
is considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of eye
damage, skin irritation, skin sensitization, pulmonary toxicity,
specific target organ toxicity, carcinogenicity, and acute and chronic
aquatic toxicity testing may be potentially useful to characterize the
human health and environmental effects of the PMN substances. Although
the TSCA Order does not require these tests, the TSCA Order's
restrictions remain in effect until the TSCA Order is modified or
revoked by EPA based on submission of this or other relevant
information.
CFR citations: 40 CFR 721.11481 (P-18-74) and 40 CFR 721.11482 (P-
18-75).
PMN Number: P-18-160
Chemical name: Heteropolycyclic, halo substituted alkyl
substituted- diaromatic amino substituted carbomonocycle, halo
substituted alkyl substituted heteropolycyclic, tetraaromatic metalloid
salt (1:1) (generic).
CAS number: Not available.
Effective date of TSCA section 5(e) Order: December 10, 2019.
Basis for TSCA section 5(e) Order: The PMN states that the generic
(non-confidential) use of the substance will be as a coating component.
EPA identified concerns for acute toxicity, neurotoxicity, eye
irritation, and photosensitization based on physical/chemical
properties and comparison to analogous chemical substances. EPA has
also identified concerns for aquatic toxicity based on comparison to
analogous cationic dyes. The Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the
absence of sufficient information to permit a reasoned evaluation the
substance may present an unreasonable risk of injury to human health
and the environment. To protect against these risks, the TSCA Order
requires:
Submission to EPA of certain toxicity testing before manufacturing
the chemical for more than 18 months;
Use of personal protective equipment where there is a
potential for dermal exposure;
Use of a NIOSH-certified respirator with an APF of at
least 50 to prevent inhalation exposure where there is a potential for
inhalation exposure;
Establishment of a hazard communication program, including
health precautionary statements on each label and in the SDS;
Refraining from domestic manufacture in the United States
(i.e., import only);
Refraining from manufacturing the PMN substance beyond the
confidential annual manufacture (which includes import) production
volume specified in the TSCA Order;
Refraining from manufacturing the PMN substance in the
form of a powder, liquid or gas (i.e., solid only); and
No predictable or purposeful release of a manufacturing,
processing, or use stream associated with any use of the PMN substance
into the waters of the United States.
The proposed SNUR would designate as a ``significant new use'' the
absence protective measures.
Potentially useful information: EPA has determined that certain
information about the environmental and health effects of the PMN
substance may be potentially useful in support of a request by the PMN
submitter to modify the TSCA Order, or if a manufacturer or processor
is considering submitting a SNUN for a significant new use that would
be designated by this SNUR. The submitter has agreed not to exceed
certain production volume limits without performing the combined
repeated dose toxicity with reproduction/developmental toxicity
screening test with functional observation battery test. EPA has also
determined that the results of chronic aquatic toxicity, acute
toxicity, eye irritation, specific target organ toxicity, and
photosensitization testing may be potentially useful to characterize
the environmental and human health effects
[[Page 26427]]
of the PMN substance. Although the TSCA Order does not require these
tests, the TSCA Order's restrictions remain in effect until the TSCA
Order is modified or revoked by EPA based on submission of this or
other relevant information.
CFR citation: 40 CFR 721.11483
PMN Numbers: P-18-237 and P-18-292
Chemical Names: Alkanediol, polymer with 5-isocyanato-1-
(isocyanatomethyl)-1,3,3-trimethylcyclohexane, alkylaminoalkyl
methacrylate- and dialkylheteromonocycle-blocked (generic) (P-18-237)
and Alkanediol, polymer with 5-isocyanato-1-(isocyanatomethyl)-1,3,3-
trimethylcyclohexane, alkylaminoalkyl methacrylate-blocked (generic)
(P-18-292).
CAS Numbers: Not available.
Effective date of TSCA section 5(e) Order: September 17, 2019.
Basis for TSCA section 5(e) Order: The PMNs state that the generic
(non-confidential) use of the PMN substances will be for use in print
resins. Based on estimated physical/chemical properties of the PMN
substances, comparison to structurally analogous chemical substances,
and structural alerts for methacrylates, EPA has identified eye and
skin irritation, skin sensitization, and systemic effects. Based on the
comparison to structurally analogous acrylates/methacrylates, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 1 ppb. The Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the
absence of specific information to permit a reasoned evaluation the
substance may present an unreasonable risk of injury to human health or
the environment. To protect against these risks, the TSCA Order
requires:
No manufacturing, processing, or use of the PMN substances
in any manner or method that generates dust, spray, vapor, mist, or
aerosol; and
No predictable or purposeful release of a manufacturing,
processing, or use stream associated with any use of the PMN substance
into the waters of the United States exceeding a surface water
concentration of 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 to characterize the human health
and environmental effects of the PMN substances if a manufacturer or
processor is considering submitting a SNUN for a significant new use
that would be designated by this proposed SNUR. EPA has determined that
the results of chronic aquatic toxicity, eye irritation, skin
irritation, skin sensitization, and specific target organ toxicity
testing would help characterize the potential health and environmental
effects of the PMN substances.
CFR citations: 40 CFR 721.11484 (P-18-237) and 40 CFR 721.11485 (P-
18-292).
PMN Number: P-18-287
Chemical Name: Synthetic oil from tires (generic).
CAS Number: Not available.
Effective Date of TSCA section 5(e) Order: December 17, 2019.
Basis for TSCA section 5(e) Order: The PMN states that the generic
(non-confidential) use of the substance will be to produce ``tires,
wastes, pyrolyzed, condensate oil fraction'' (CASRN 1312024-02-4) from
scrap tire materials. The synthetic oil fraction from tire waste
pyrolysis can be used in a variety of industries. Some examples of use
of synthetic oil include use as a fuel, upgraded for use as a higher
quality fuel, as an additive for asphalt or other complex mixtures,
used to manufacture other chemicals, etc. EPA has identified concerns
for irritation and neurotoxicity based on structural alerts for
solvents, and systemic toxicity, developmental/reproductive toxicity,
and carcinogenicity based on a constituent of the new chemical,
benzene. EPA has also identified aspiration hazard based on measured
kinematic viscosity. Based on SAR analysis of analogous neutral
organics, EPA predicts 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 and the environment. To protect against these risks, the
TSCA Order requires:
No manufacture of the PMN substance other than as
described in the PMN;
No manufacturing, processing, or use of the PMN substance
for consumer or ``commercial uses'' (as the term is defined at 40 CFR
721.3) when the saleable goods or service could introduce the PMN
substance into a ``consumer'' setting (as that term is defined in 40
CFR 721.3); and
Waste streams from manufacture, processing, and use must
be disposed of only by incineration.
The proposed SNUR would designate as a ``significant new use'' in
the absence of these protective measures.
Potentially useful information: EPA has determined that certain
information about the environmental and health effects of the PMN
substance may be potentially useful in support of a request by the PMN
submitter to modify the TSCA Order, or if a manufacturer or processor
is considering submitting a SNUN for a significant new use that would
be designated by this SNUR. EPA has determined that the results of
aquatic toxicity, skin irritation, eye irritation, specific target
organ toxicity, reproductive toxicity (developmental effects), and
carcinogenicity testing may be potentially useful to characterize the
environmental and human health effects of the PMN substance. Although
the TSCA Order does not require these tests, the TSCA Order's
restrictions remain in effect until the TSCA Order is modified or
revoked by EPA based on submission of this or other relevant
information.
CFR citation: 40 CFR 721.11486.
PMN Number: P-19-51
Chemical name: 1,3-Propanediamine, N1,N1-dimethyl-, polymers with
alkylene glycol ether with alkyltriol (3:1) mixed acrylates and
adipates, and alkylene glycol monoacrylate ether with alkyltriol (3:1)
(generic).
CAS number: Not available.
Effective date of TSCA section 5(e) Order: October 22, 2019.
Basis for TSCA section 5(e) Order: The PMN states that the generic
(non-confidential) use of the substance will be as a UV curable ink.
EPA has identified concerns for skin and respiratory sensitization and
skin and eye irritation based on the methacrylate/acrylate composition.
EPA also identified liver effects based on the extent the low molecular
weight fractions are bioavailable. Based on comparison to analogous
polycationic polymers, EPA predicts toxicity to aquatic organisms may
occur at concentrations that exceed 3 ppb. The Order was issued under
TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a
finding that in the absence of sufficient information to permit a
reasoned evaluation, the substance may present an unreasonable risk of
injury to human health and the environment. To protect against these
risks, the TSCA Order requires:
Establishment of a hazard communication program, including
human health precautionary statements on each label and in the SDS;
No domestic manufacture of the PMN substance (i.e., import
only);
[[Page 26428]]
No use of the PMN substance other than for the
confidential use specified in the TSCA Order; and
No predictable or purposeful release of a manufacturing,
processing, or use stream associated with any use of the PMN substance
into the waters of the United States exceeding a surface water
concentration of 3 ppb.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful to characterize the human health
and environmental effects of the PMN substance in support of a request
by the PMN submitter to modify the TSCA Order, or if a manufacturer or
processor is considering submitting a SNUN for a significant new use
that would be designated by this SNUR. EPA has determined that the
results of acute and chronic aquatic toxicity, specific target organ
toxicity, skin sensitization, skin irritation, and eye irritation
testing would help EPA determine the potential human and environmental
effects of the PMN substance. Although the TSCA Order does not require
this information, the TSCA Order's restrictions remain in effect until
the TSCA Order is modified or revoked by EPA based on submission of
this or other relevant information.
CFR citation: 40 CFR 721.11487.
PMN Number: P-19-55
Chemical Name: 1,3-Propanediol, 2-ethyl-2-(hydroxymethyl)-, polymer
with oxirane, 4-(dimethylamino)benzoate.
CAS Number: 2067275-86-7.
Effective Date of TSCA section 5(e) Order: January 14, 2020.
Basis for TSCA section 5(e) Order: The PMN states that the use of
the substance will be as a photo initiator within UV curable coating/
ink formulations. Based on submitted test data, EPA has identified
concerns for sensitization, reproductive, and systemic effects. Based
on submitted acute and chronic toxicity data, EPA has also identified
concern for toxicity to aquatic organisms may occur at concentrations
that exceed 12 ppb. The Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the
absence of sufficient information to permit a reasoned evaluation the
substance may present an unreasonable risk of injury to human health
and the environment. To protect against these risks, the TSCA Order
requires:
No manufacturing, processing, or use of the PMN substance
in any manner that results in inhalation exposure;
No use of the PMN substance other than as a photo
initiator within UV curable coating/ink formulations; and
No predictable or purposeful release of a manufacturing,
processing, or use stream associated with any use of the PMN substance
into the waters of the United States exceeding a surface water
concentration of 12 ppb.
The proposed SNUR would designate as a ``significant new use'' in
the absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information about the environmental effects of the PMN substance may be
potentially useful in support of a request by the PMN submitter to
modify the TSCA Order, or if a manufacturer or processor is considering
submitting a SNUN for a significant new use that would be designated by
this SNUR. EPA has determined that the results of developmental/
reproductive toxicity testing may be potentially useful to characterize
the human health effects of the PMN substance. Although the TSCA Order
does not require these tests, the TSCA Order's restrictions remain in
effect until the TSCA Order is modified or revoked by EPA based on
submission of this or other relevant information.
CFR citation: 40 CFR 721.11488.
PMN Number: P-19-159
Chemical Name: Titanium (4+) hydroxyl-alkylcarboxylate salt complex
(generic).
CAS Number: Not available.
Effective Date of TSCA section 5(e) Order: January 10, 2020.
Basis for TSCA section 5(e) Order: The PMN states that the generic
(non-confidential) use of the substance will be as a catalyst in the
industrial sector. Based on the reactive nature of the PMN substance,
presence of acid moieties, titanium (to the extent it is bioavailable),
and information in the SDS, EPA has identified concerns for irritation
to the eyes, skin, and respiratory tract, severe skin burns and eye
damage, and skin and respiratory sensitization. Based on test data
available on the PMN substance and comparison to analogous substances,
EPA predicts toxicity to aquatic organisms may occur at concentrations
that exceed 1 ppb. The Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the
absence of sufficient information to permit a reasoned evaluation the
substance may present an unreasonable risk of injury to human health
and the environment. To protect against these risks, the TSCA Order
requires:
No manufacture, processing, or use of the PMN substance in
any manner or method that generates inhalation exposure; and
No predictable or purposeful release of a manufacturing,
processing, or use stream associated with any use of the PMN substance
into the waters of the United States exceeding a surface water
concentration of 1 ppb.
The proposed SNUR would designate as a ``significant new use'' in
the absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information about the human health effects of the PMN substance may be
potentially useful in support of a request by the PMN submitter to
modify the TSCA Order, or if a manufacturer or processor is considering
submitting a SNUN for a significant new use that would be designated by
this SNUR. EPA has determined that the results of pulmonary effects,
skin irritation, eye irritation, skin sensitization, and specific
target organ toxicity testing may be potentially useful to characterize
the human health effects of the PMN substance. Although the TSCA Order
does not require these tests, the TSCA Order's restrictions remain in
effect until the TSCA Order is modified or revoked by EPA based on
submission of this or other relevant information.
CFR citation: 40 CFR 721.11489.
V. Rationale and Objectives of the Proposed Rule
A. Rationale
During review of the PMNs submitted for the chemical substances
that are 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 TSCA section 5(e) Orders with a SNUR that
identifies the absence of those protective measures as Significant New
Uses to ensure that all manufacturers and processors--not just the
original submitter--are held to the same standard.
B. Objectives
EPA is proposing these SNURs for specific chemical substances which
have undergone premanufacture review because the Agency wants:
To identify as significant new uses any manufacturing,
processing, use,
[[Page 26429]]
distribution in commerce, or disposal that does not conform to the
restrictions imposed by the underlying TSCA Orders, consistent with
TSCA section 5(f)(4).
To have an opportunity to review and evaluate data
submitted in a SNUN before the notice submitter begins manufacturing or
processing a listed chemical substance for the described significant
new use.
To be able to either determine that the prospective
manufacture or processing is not likely to present an unreasonable
risk, or to take necessary regulatory action associated with any other
determination, before the described significant new use of the chemical
substance occurs.
VI. Applicability of the Proposed Significant New Use Designation
To establish a significant new use, EPA must determine that the use
is not ongoing. The chemical substances subject to this proposed rule
have undergone premanufacture review. In cases where EPA has not
received a notice of commencement (NOC) and the chemical substance has
not been added to the TSCA Inventory, no person may commence such
activities without first submitting a PMN. Therefore, for chemical
substances for which an NOC has not been submitted EPA concludes that
the designated significant new uses are not ongoing.
When chemical substances identified in this proposed rule are added
to the TSCA Inventory, EPA recognizes that, before the rule is
effective, other persons might engage in a use that has been identified
as a significant new use. However, TSCA section 5(e) Orders have been
issued for these chemical substances, and the PMN submitters are
prohibited by the TSCA section 5(e) Orders from undertaking activities
which would be designated as significant new uses. The identities of 18
of the 24 chemical substances subject to this proposed rule have been
claimed as confidential (per 40 CFR 720.85) for a chemical substance
covered by this action. 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 May 4, 2020 as the cutoff date for
determining whether the new use is ongoing. The objective of EPA's
approach is to ensure that a person cannot defeat a SNUR by initiating
a significant new use before the effective date of the final rule.
In the unlikely event that a person began commercial manufacture or
processing of the chemical substances for a significant new use
identified as of that date would have to cease any such activity upon
the effective date of the final rule. To resume their activities, these
persons would have to first comply with all applicable SNUR
notification requirements and wait until EPA has conducted a review of
the notice, made an appropriate determination on the notice, and has
taken such actions as are required with that determination.
Issuance of a SNUR for a chemical substance does not signify that
the chemical substance is listed on the TSCA Chemical Substance
Inventory (TSCA Inventory). Guidance on how to determine if a chemical
substance is on the TSCA Inventory is available on the internet at
http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html.
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, 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).
However, upon review of PMNs and SNUNs, the Agency has the authority to
require appropriate testing. Unit IV. lists potentially useful
information for all SNURs listed here. Descriptions of this information
is provided for informational purposes. The potentially useful
information identified in Unit IV of the proposed rule will be useful
to EPA's evaluation in the event that someone submits a SNUN for the
significant new use. Companies who are considering submitting a SNUN
are encouraged, but not required, to develop the information on the
substance, which may assist with EPA's analysis of the SNUN. EPA
strongly encourages persons, before performing any testing, to consult
with the Agency. Furthermore, pursuant to TSCA section 4(h), which
pertains to reduction of testing on vertebrate animals, EPA encourages
dialog with the Agency on the use of alternative test methods and
strategies (also called New Approach Methodologies, or NAMs), if
available, to generate the potentially useful information. EPA
encourages dialogue with Agency representatives to help determine how
best the submitter can meet both the data needs and the objective of
TSCA section 4(h). To access the OCSPP test guidelines referenced in
this document electronically, please go to http://www.epa.gov/ocspp and
select ``Test Methods and Guidelines.'' The Organisation for Economic
Co-operation and Development test guidelines are available from the
OECD Bookshop at http://www.oecdbookshop.org or SourceOECD at http://www.sourceoecd.org.
The potentially useful information listed in Unit IV. may not be
the only means of addressing the potential risks of the chemical
substance. However, submitting a SNUN without any test data or other
information may increase the likelihood that EPA will take action under
TSCA section 5(e) or 5(f). EPA recommends that potential SNUN
submitters contact EPA early enough so that they will be able to
conduct the appropriate tests.
SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs which provide detailed information on the following:
Human exposure and environmental release that may result
from the significant new use of the chemical substances.
Information on risks posed by the chemical substances
compared to risks posed by potential substitutes.
VIII. SNUN Submissions
According to 40 CFR 721.1(c), persons submitting a SNUN must comply
with the same notification requirements and EPA regulatory procedures
as persons submitting a PMN, including submission of test data on
health and environmental effects as described in 40 CFR 720.50. SNUNs
must be submitted on EPA Form No. 7710-25, generated using e-PMN
software, and submitted to the Agency in accordance with the procedures
set forth in 40 CFR 720.40. E-PMN software is available electronically
at http://www.epa.gov/opptintr/newchems.
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
[[Page 26430]]
docket under docket ID number EPA-HQ-OPPT-2019-0596.
X. Statutory and Executive Order Reviews
Additional information about these statutes and Executive Orders
can be found at https://www.epa.gov/laws-regulations-and-executive-orders.
A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulations and Regulatory Review
This proposed rule would establish SNURs for 3 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 Order 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 requirements related to this action have
already been approved by OMB pursuant to PRA under OMB control number
2070-0012 (EPA ICR No. 574). 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.
Send any comments about the accuracy of the burden estimate, and
any suggested methods for minimizing respondent burden, including
through the use of 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 section 605(b) of the RFA, 5 U.S.C. 601 et seq., the
Agency hereby certifies that promulgation of this proposed SNUR 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. Although some small entities may decide to pursue a
significant new use in the future, EPA cannot presently determine how
many, if any, there may be. However, 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, 12 in FY2016, 13 in FY2017, and
11 in FY2018, 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 proposed
rule. As such, EPA has determined that this proposed rule does 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. 1531-1538 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 proposed rule would not have Tribal implications because it is
not expected to have substantial direct effects on Indian Tribes. This
proposed rule would not significantly nor uniquely affect the
communities of Indian Tribal governments, nor does 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 proposed rule.
G. Executive Order 13045: Protection of Children From Environmental
Health 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 proposed rule 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 is not a
significant regulatory action under Executive Order 12866.
I. National Technology Transfer and Advancement Act (NTTAA)
In addition, since this action does not involve any technical
standards, NTTAA section 12(d), 15 U.S.C. 272 note, does not apply to
this action.
[[Page 26431]]
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
40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: April 13, 2020.
Tala Henry,
Deputy Director, Office of Pollution Prevention and Toxics.
Therefore, it is proposed that 40 CFR chapter I be amended as
follows:
PARTS 721--[AMENDED]
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. 721.11466 through 721.11489 to subpart E to read as
follows:
Subpart E--Significant New Uses for Specific Chemical Substances
* * * * *
Secs.
721.11466 Aromatic amide oxime (generic).
721.11467 Carbon nanotubes (generic).
721.11468 Aromatic hydrocarbon resin (generic).
721.11469 Pentaerythritol ester of mixed linear and branched
carboxylic acids (generic) (P-17-193, chemical A).
721.11470 Dipentaerythritol ester of mixed linear and branched
carboxylic acids (generic) (P-17-193, chemical B).
721.11471 Alkylheterocyclic amine blocked isocyanate, alkoxysilane
polymer (generic).
721.11472 Isocyanic acid, polymethylenepolyphenylene ester,
caprolactam- and phenol-blocked.
721.11473 Benzamide, 2-(trifluoromethyl)-.
721.11474 Cashew, nutshell liq. polymer with formaldehyde, phenol
and resorcinol.
721.11475 Polyester polyol (generic).
721.11476 Fluorinated acrylate, polymer with alkyloxirane
homopolymer monoether with alkanediol mono(2-methyl-2-propenoate),
tert-Bu 2-ethylhexaneperoxoate-initiated (generic).
721.11477 2,5-Furandione, polymer with 2-ethyl-2-(hydroxymethyl)-
1,3-propanediol, 3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-inden-5(or
6)-yl ester, ester with 2,3-dihydroxypropyl neodecanoate, polymer
with 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane,
2-hydroxyethyl acrylate- and 2-hydroxyethyl methacrylate-blocked.
721.11478 Perfluoroalkyl ethyl- and vinyl-modified
organopolysiloxane (generic).
721.11479 Perfluoroalkyl ethyl- and vinyl-modified
organopolysiloxane (generic).
721.11480 Oxirane, 2,2'-[cyclohexylidenebis(4,1-
phenyleneoxymethylene)]bis-.
721.11481 Saturated fatty acid, reaction products with cadmium zinc
selenide sulfide and polymeric amine (generic).
721.11482 Saturated fatty acid, reaction products with cadmium zinc
selenide sulfide, alkylamine and polymeric amine (generic).
721.11483 Heteropolycyclic, halo substituted alkyl substituted-
diaromatic amino substituted carbomonocycle, halo substituted alkyl
substituted heteropolycyclic, tetraaromatic metalloid salt (1:1)
(generic).
721.11484 Alkanediol, polymer with 5-isocyanato-1-
(isocyanatomethyl)-1,3,3-trimethylcyclohexane, alkylaminoalkyl
methacrylate-, and dialkylheteromonocycle-blocked (generic).
721.11485 Alkanediol, polymer with 5-isocyanato-1-
(isocyanatomethyl)-1,3,3-trimethylcyclohexane, alkylaminoalkyl
methacrylate-blocked (generic).
721.11486 Synthetic oil from tires (generic).
721.11487 1,3-Propanediamine, N1,N1-dimethyl-, polymers with
alkylene glycol ether with alkyltriol (3:1) mixed acrylates and
adipates, and alkylene glycol monoacrylate ether with alkyltriol
(3:1) (generic).
721.11488 1,3-Propanediol, 2-ethyl-2-(hydroxymethyl)-, polymer with
oxirane, 4-(dimethylamino)benzoate.
721.11489 Titanium (4+) hydroxyl-alkylcarboxylate salt complex
(generic).
* * * * *
Sec. 721.11466 Aromatic amide oxime (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
aromatic amide oxime (PMN P-14-865) 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) through (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(a)(6), particulate (including solids or liquid droplets).
For purposes of Sec. 721.63(b), concentration is set at 1.0%.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(g).
(iii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4) and, (c)(4) where N = 30.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (e), (i), and (k) are applicable to manufacturers
and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11467 Carbon nanotubes (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as carbon
nanotubes (PMN P-15-54) 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 PMN
substance that have been (i) embedded or incorporated into a polymer
matrix that itself has been reacted (cured) or (ii) embedded in a
permanent solid polymer form that is not intended to undergo further
processing, except mechanical processing.
(2) The significant new uses are:
(i) Workplace protection. Requirements as specified in Sec.
721.63(a)(1), (2)(i) and (ii), (3), (4) 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), particulate (including solids or liquid
droplets).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) (chemical intermediate to manufacture
functionalized carbon nanotubes by oxidation with nitric acid; additive
in rubber polymers to improve mechanical/physical/chemical/electrical
properties; additive in resin polymers to improve mechanical/physical/
chemical/electrical properties;
[[Page 26432]]
additive in metals to improve electrical/thermal properties; additive
in ceramics to improve mechanical/electrical/thermal properties; semi-
conductor, conductive, or resistive element in electronic circuitry and
devices; electric collector element or electrode in energy devices;
photoelectric or thermoelectric conversion elements in energy devices;
catalyst support element or catalytic electrode for use in energy
devices; additive for transparency and conductivity in electronic
devices; and electro-mechanical element in actuator, sensor, or
switching devices).
(iii) Disposal. Requirements as specified in Sec. 721.85(a)(1) and
(2), (b)(1) and (2), and (c)(1) and (2).
(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 and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11468 Aromatic hydrocarbon resin (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
aromatic hydrocarbon resin (PMN P-16-583) 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 reacted (cured).
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) (hot-melt sealant for motor vehicle
lamps). It is a significant new use to manufacture the PMN substance
with an average number molecular weight of less than 1000 grams per
mole.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11469 Pentaerythritol ester of mixed linear and branched
carboxylic acids (generic) (P-17-193, chemical A).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
pentaerythritol ester of mixed linear and branched carboxylic acids
(PMN P-17-193, chemical A) is subject to reporting under this section
for the significant new use described in paragraph (a)(2) of this
section.
(2) The significant new use is:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 330.
(ii) [Reserved]
(b) Specific requirements. The provision of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain modification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11470 Dipentaerythritol ester of mixed linear and branched
carboxylic acids (generic) (P-17-193, chemical B).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
dipentaerythritol ester of mixed linear and branched carboxylic acids
(PMN P-17-193, chemical B) is subject to reporting under this section
for the significant new use described in paragraph (a)(2) of this
section.
(2) The significant new use is:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 330.
(ii) [Reserved]
(b) Specific requirements. The provision of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain modification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11471 Alkylheterocyclic amine blocked isocyanate,
alkoxysilane polymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkylheterocyclic amine blocked isocyanate, alkoxysilane polymer (PMN
P-17-221) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section. The
requirements of this TSCA Order do not apply to quantities of the PMN
substance after they have been completely reacted (cured).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) and (iii), (a)(3) and (6) (particulate), (b)
(concentration set at 1.0%), and (c). When determining which persons
are reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (e) (concentration set at 1.0%), (f), (g)(1)(i)
and (ii), (2)(i) through (iii), (v), and (g)(5). Alternative hazard and
warning statements that meet the criteria of the Globally Harmonized
System (GHS) 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
formulate the PMN to a concentration greater than 10%.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers and processors
of this substance.
(2) Limitations or revocation of certain 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).
Sec. 721.11472 Isocyanic acid, polymethylenepolyphenylene ester,
caprolactam- and phenol-blocked.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as isocyanic acid,
polymethylenepolyphenylene ester, caprolactam- and phenol-blocked (PMN
[[Page 26433]]
P-17-282, CAS NO. 2093945-13-0) is subject to reporting under this
section for the significant new uses described 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. It is a
significant new use to manufacture, process, or use the PMN substance
in any manner or method that generates inhalation exposure to phenol or
caprolactam.
(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 provision of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i), and (k) are applicable to manufacturers
and processors of this substance.
(2) Limitations or revocation of certain modification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11473 Benzamide, 2-(trifluoromethyl)-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as benzamide, 2-
(trifluoromethyl)- (PMN P-17-334, CAS No. 360-64-5) 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), (2)(i) and (iv), (3), (4), (6)(v) and (vi) (particulate),
(b) (concentration set at 0.1%), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (e) (concentration set at 0.1%), (f),
(g)(1)(iii) through (v), and (ix), (2)(i) through (iii), and (v),
(3)(i) and (ii), and (5). Alternative hazard and warning statements
that meet the criteria of the Globally Harmonized System (GHS) and OSHA
Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (g), and (y)(1).
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 39.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11474 Cashew, nutshell liq. polymer with formaldehyde,
phenol and resorcinol.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as cashew nutshell
liq. polymer with formaldehyde, phenol and resorcinol (PMN P-17-386,
CAS No. 2044014-81-3) 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 reacted (cured).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (3) through (5), (6)(v) and (vi) ((particulate),
(combination gas/vapor and particulate)), (b) (concentration set at
1.0%), 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), (e) (concentration set at 1.0%), (f), (g)(1)(i)
(skin and respiratory sensitization), (2)(i), (ii), (iv), (v),
(4)(iii), and (5). 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 the substance for more than one year.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers and processors
of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11475 Polyester polyol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polyester polyol (PMN P-18-12) is subject to reporting under this
section for the significant new use described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 1.
(ii) [Reserved]
(b) Specific requirements. The provision of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain modification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11476 Fluorinated acrylate, polymer with alkyloxirane
homopolymer monoether with alkanediol mono(2-methyl-2-propenoate),
tert-Bu 2-ethylhexaneperoxoate-initiated (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
fluorinated acrylate, polymer with alkyloxirane homopolymer monoether
with alkanediol mono(2-methyl-2-propenoate), tert-Bu 2-
ethylhexaneperoxoate-initiated (PMN P-18-18) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (t), and (y)(1).
(ii) Releases to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
[[Page 26434]]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i), and (k) are applicable to manufacturers
and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
Sec. 721.11477 2,5-Furandione, polymer with 2-ethyl-2-
(hydroxymethyl)-1,3-propanediol, 3a,4,5,6,7,7ahexahydro- 4,7-methano-
1H-inden-5(or 6)-yl ester, ester with 2,3-dihydroxypropyl neodecanoate,
polymer with 5-isocyanato-l-(isocyanatomethyl)-1,3, 3-
trimethylcyclohexane, 2-hydroxyethyl acrylate- and 2-hydroxyethyl
methacrylate-blocked.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2,5-furandione,
polymer with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol,
3a,4,5,6,7,7ahexahydro- 4,7-methano-1H-inden-5(or 6)-yl ester, ester
with 2,3-dihydroxypropyl neodecanoate, polymer with 5-isocyanato-l-
(isocyanatomethyl)-1,3, 3-trimethylcyclohexane, 2-hydroxyethyl
acrylate- and 2-hydroxyethyl methacrylate-blocked (PMN P-18-42, CAS No.
2245262-16-0) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the PMN
substance after they have been completely reacted (cured).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (2)(i) through (iv), (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)(i), (ii), (iv), (vii), (ix) (eye
irritation), (2)(i) through (iii), (v) (avoid eye contact), and (5).
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System (GHS) and OSHA Hazard Communication Standard
may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k), (o), and (y)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers and processors
of this substance.
(2) Limitations or revocation of certain 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).
Sec. 721.11478 Perfluoroalkyl ethyl- and vinyl-modified
organopolysiloxane (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
perfluoroalkyl ethyl- and vinyl-modified organopolysiloxane (PMN P-18-
52) 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) through (5), and (c). When determining which persons are
reasonably likely to be exposed as required by 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), (6)(combination gas/vapor and particulate.
(A) As an alternative to 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 TSCA
section 5(e) consent order for this substance. The NCEL is 0.0015 mg/
m\3\ as an 8-hour time weighted average. Persons who wish to pursue
NCELs as an alternative to Sec. 721.63 respirator requirements may
request to do so under Sec. 721.30. Persons whose Sec. 721.30
requests to use the NCELs approach are approved by EPA will be required
to follow NCELs provisions comparable to those contained in the
corresponding TSCA section 5(e) consent order.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1)(vi) (specific target organ
toxicity), (2)(i) through (v), and (5). Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System
(GHS) and OSHA Hazard Communication Standard may be used. For purposes
of Sec. 721.72(g)(2)(iv), use respiratory protection or maintain
workplace airborne concentrations at or below an 8-hour time-weighted
average of 0.0015 mg/m\3\.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f) and (t) (420 kilograms).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers and processors
of this substance.
(2) Limitations or revocation of certain modification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11479 Perfluoroalkyl ethyl- and vinyl-modified
organopolysiloxane (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
perfluoroalkyl ethyl- and vinyl-modified organopolysiloxane (PMN P-18-
53) 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), (3) through (6) (combination gas/vapor and particulate),
and (c). When determining which persons are reasonably likely to be
exposed as required by 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
[[Page 26435]]
(NIOSH) assigned protection factor (APF) of at least 1,000.
(A) As an alternative to 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 TSCA
section 5(e) consent order for this substance. The NCEL is 0.0015 mg/
m\3\ as an 8-hour time weighted average. Persons who wish to pursue
NCELs as an alternative to Sec. 721.63 respirator requirements may
request to do so under Sec. 721.30. Persons whose Sec. 721.30
requests to use the NCELs approach are approved by EPA will be required
to follow NCELs provisions comparable to those contained in the
corresponding TSCA section 5(e) consent order.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1)(vi) (specific target organ
toxicity), (2)(i) through (v), and (5). Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System
(GHS) and OSHA Hazard Communication Standard may be used. For purposes
of Sec. 721.63(g)(2)(iv), use respiratory protection or maintain
workplace airborne concentrations at or below an 8-hour time-weighted
average of 0.0015 mg/m\3\.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f) and (t) (336 kilograms).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers and processors
of this substance.
(2) Limitations or revocation of certain modification requirements.
The provisions of Sec. 1721.185 apply to this section.
Sec. 721.11480 Oxirane, 2,2'-[cyclohexylidenebis(4,1-
phenyleneoxymethylene)]bis-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical identified as oxirane, 2,2'-
[cyclohexylidenebis(4,1-phenyleneoxymethylene)]bis- (PMN P-18-62, CAS
No. 13446-84-9) is subject to reporting under this section for the
significant new use described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the PMN
substance after they have been completely reacted (cured).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (3) through (6) (particulate including solids or liquid
droplets), (b) (concentration set at 0.1%), 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.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e) (concentration set at 0.1%), (f), (g)(1)(vi),
(vii) (specific target organ toxicity), (2)(i) through (iii) (use
respiratory protection when spraying), (v), (3)(i) and (ii), (4)(i),
and (5). Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System (GHS) 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 or process the PMN substance in any manner which generates
inhalation exposures.
(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 provision of subpart A of this part
apply to this section as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i), and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain modification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.
Sec. 721.11481 Saturated fatty acid, reaction products with cadmium
zinc selenide sulfide and polymeric amine (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical identified generically as saturated fatty
acid, reaction products with cadmium zinc selenide sulfide and
polymeric amine (PMN P-18-74) is subject to reporting under this
section for the significant new use described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (3), (6) (particulate (including solids or liquid
droplets), 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)(i), (vii) ((pulmonary toxicity),
(eye damage), (specific target organ toxicity), (skin sensitization)),
(2)(i) through (iii), and (v), (3)(i) and (ii), (4)(i) and (iii), and
(5). 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) (chemical intermediate for a quantum
dot used as an optical down-converter (50%), and quantum dot in an
optical down-converter (50%)). It is a significant new use to
manufacture, process, or use the PMN substance in other than a liquid
formulation. It is a significant new use to manufacture or process the
PMN substance in any manner which generates inhalation exposures. It is
a significant new use to manufacture the PMN substance with a cadmium
percentage greater than the confidential level identified in the TSCA
Order.
(iv) Disposal. It is a significant new use to dispose of the PMN
substance in any manner other than by incineration in a permitted
hazardous waste incinerator.
(v) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provision of subpart A of this part
apply to this section as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (d), and (f) through (k) are applicable to
manufacturers and processors of this substance.
(2) Limitations or revocation of certain modification requirements.
The provisions of Sec. 721.185 apply to this section.
[[Page 26436]]
(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. 721.11482 Saturated fatty acid, reaction products with cadmium
zinc selenide sulfide, alkylamine and polymeric amine (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical identified generically as saturated fatty
acid, reaction products with cadmium zinc selenide sulfide, alkylamine
and polymeric amine (PMN P-18-75) is subject to reporting under this
section for the significant new use described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (3), (6) (particulate (including solids or liquid
droplets)), 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)(i), (vii) ((pulmonary toxicity),
(eye damage), (specific target organ toxicity), (skin sensitization)),
(2)(i) through (iii), and (v), (3)(i) and (ii), (4)(i) and (iii), and
(5). 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)(quantum dot in an optical down-
converter). It is a significant new use to manufacture, process, or use
the PMN substance in other than a liquid formulation. It is a
significant new use to manufacture or process the PMN substance in any
manner which generates inhalation exposures. It is a significant new
use to manufacture the PMN substance with a cadmium percentage greater
than the confidential value stated in the TSCA Order.
(iv) Disposal. It is a significant new use to dispose of the PMN
substance in any manner other than by incineration in a permitted
hazardous waste incinerator.
(v) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provision of subpart A of this part
apply to this section as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (d), and (f) through (k) are applicable to
manufacturers and processors of this substance.
(2) Limitations or revocation of certain modification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.
Sec. 721.11483 Heteropolycyclic, halo substituted alkyl substituted-
diaromatic amino substituted carbomonocycle, halo substituted alkyl
substituted heteropolycyclic, tetraaromatic metalloid salt (1:1)
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
heteropolycyclic, halo substituted alkyl substituted- diaromatic amino
substituted carbomonocycle, halo substituted alkyl substituted
heteropolycyclic, tetraaromatic metalloid salt (1:1) (PMN P-18-160) 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), (2)(i) through (iv), and (3) through (6) ((solids),
(liquid droplets)). 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 (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) ((acute toxicity), (neurotoxicity),
(photosensitization), (eye irritation)), (2)(i) through (v), (3)(i) and
(ii), and (4)(iii). Alternative hazard and warning statements that meet
the criteria of the Globally Harmonized System (GHS) and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (t), and (w)(1), (3), and (4). It is a
significant new use to manufacture the substance for more than 18
months.
(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 (c), (i), and (k) are applicable to manufacturers
and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.
Sec. 721.11484 Alkanediol, polymer with 5-isocyanato-1-
(isocyanatomethyl)-1,3,3-trimethylcyclohexane, alkylaminoalkyl
methacrylate-, and dialkylheteromonocycle-blocked (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkanediol, polymer with 5-isocyanato-1-(isocyanatomethyl)-1,3,3-
trimethylcyclohexane, alkylaminoalkyl methacrylate-, and
dialkylheteromonocycle-blocked (PMN P-18-237) 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 reacted (cured).
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the PMN substance
in any manner or method that generates dust, spray, vapor, mist, or
aerosol.
(ii) Releases to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 1.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i), and (k) are applicable to manufacturers
and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
[[Page 26437]]
Sec. 721.11485 Alkanediol, polymer with 5-isocyanato-1-
(isocyanatomethyl)-1,3,3-trimethylcyclohexane, alkylaminoalkyl
methacrylate-blocked (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkanediol, polymer with 5-isocyanato-1-(isocyanatomethyl)-1,3,3-
trimethylcyclohexane, alkylaminoalkyl methacrylate-blocked (PMN P-18-
292) 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 reacted (cured).
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the PMN substance
in any manner or method that generates dust, spray, vapor, mist, or
aerosol.
(ii) Releases to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 1.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i), and (k) are applicable to manufacturers
and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11486 Synthetic oil from tires (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
synthetic oil from tires (PMN P-18-287) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (o).
(ii) Disposal. Requirements as specified in Sec. 721.85(a)(1),
(b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i) and (j) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
Sec. 721.11487 1,3-Propanediamine, N1,N1-dimethyl-, polymers with
alkylene glycol ether with alkyltriol (3:1) mixed acrylates and
adipates, and alkylene glycol monoacrylate ether with alkyltriol (3:1)
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as 1,3-
propanediamine, N1,N1-dimethyl-, polymers with alkylene glycol ether
with alkyltriol (3:1) mixed acrylates and adipates, and alkylene glycol
monoacrylate ether with alkyltriol (3:1) (PMN P-19-51) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section. The requirements of this section do
not apply to quantities of the PMN substance after they have been
completely reacted (cured).
(2) The significant new uses are:
(i) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e) (concentration set at 0.1%), (f), (g)(1)(i), (iv)
((eye irritation), (skin sensitization), (respiratory sensitization)),
(2)(i) through (v), (3)(i) and (ii), (4)(i) and (ii), and (5).
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System (GHS) and OSHA Hazard Communication Standard
may be used.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f) and (k).
(iii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 3.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (d), (f) through (i), and (k) are applicable to
manufacturers and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.
Sec. 721.11488 1,3-Propanediol, 2-ethyl-2-(hydroxymethyl)-, polymer
with oxirane, 4-(dimethylamino)benzoate.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1,3-propanediol, 2-
ethyl-2-(hydroxymethyl)-, polymer with oxirane, 4-
(dimethylamino)benzoate (PMN P-19-55, CAS No. 2067275-86-7) is subject
to reporting under this section for the significant new uses described
in paragraph (a)(2) if this section. The requirements of this section
do not apply to quantities of the PMN substance after they have been
completely reacted (cured).
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k)(photo initiator within UV curable
coating/ink formulations). It is a significant new use to manufacture,
process, or use the PMN substance in any manner that results in
inhalation exposure.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 12.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i), and (k) are applicable to manufacturers
and processors of this substance.
(2) Limitations or revocation of certain modification requirements.
The provisions of Sec. 1721.185 apply to this section.
Sec. 721.11489 Titanium (4+) hydroxyl-alkylcarboxylate salt complex
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
titanium (4+) hydroxyl-alkylcarboxylate salt complex (PMN P-19-159) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the substance after they have
been completely reacted (cured).
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the PMN substance
in any manner or method that generates inhalation exposure.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 1.
(b) Specific requirements. The provision of subpart A of this part
apply
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to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i), and (k) are applicable to manufacturers
and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
[FR Doc. 2020-08714 Filed 5-1-20; 8:45 am]
BILLING CODE 6560-50-P