Significant New Use Rules on Certain Chemical Substances (20-1.5e), 26419-26438 [2020-08714]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[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: https://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute.
     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 https://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://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 https://www.epa.gov/dockets/comments.html.

II. Background

A. What action is the agency taking?

    EPA is proposing these SNURs under TSCA section 5(a)(2) 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 
https://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/.

VII. Development and Submission of Information

    EPA recognizes that TSCA section 5 does not require developing any 
particular new information (e.g., generating test data) before 
submission of a SNUN. There is an exception: If a person is required to 
submit information for a chemical substance pursuant to a rule, 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 https://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 https://www.oecdbookshop.org or SourceOECD at https://www.sourceoecd.org.
    The potentially useful information listed in Unit IV. may not be 
the only means of addressing the potential risks of the chemical 
substance. However, submitting a SNUN without any test data or other 
information may increase the likelihood that EPA will take action under 
TSCA section 5(e) or 5(f). EPA recommends that potential SNUN 
submitters contact EPA early enough so that they will be able to 
conduct the appropriate tests.
    SNUN submitters should be aware that EPA will be better able to 
evaluate SNUNs which provide detailed information on the following:
     Human exposure and environmental release that may result 
from the significant new use of the chemical substances.
     Information on risks posed by the chemical substances 
compared to risks posed by potential substitutes.

VIII. SNUN Submissions

    According to 40 CFR 721.1(c), persons submitting a SNUN must comply 
with the same notification requirements and EPA regulatory procedures 
as persons submitting a PMN, including submission of test data on 
health and environmental effects as described in 40 CFR 720.50. SNUNs 
must be submitted on EPA Form No. 7710-25, generated using e-PMN 
software, and submitted to the Agency in accordance with the procedures 
set forth in 40 CFR 720.40. E-PMN software is available electronically 
at https://www.epa.gov/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

[[Page 26438]]

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