Document ID: EPA-HQ-OPPT-2021-0568-0001
Agency: epa
Document Type: Proposed Rule
Title: Significant New Use: Certain Chemical Substances (21-3.5e)
Posted Date: 2022-06-24T04:00Z

[Federal Register Volume 87, Number 121 (Friday, June 24, 2022)]
[Proposed Rules]
[Pages 37783-37807]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-13360]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2021-0568; FRL-9779-01-OCSPP]
RIN 2070-AB27

Significant New Use Rules on Certain Chemical Substances (21-
3.5e)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: EPA is proposing significant new use rules (SNURs) under the 
Toxic Substances Control Act (TSCA) for chemical substances that were 
the subject of premanufacture notices (PMNs) and are also subject to 
Orders issued by EPA pursuant to TSCA. The SNURs require persons who 
intend to manufacture (defined by statute to include import) or process 
any of these chemical substances for an activity that is proposed as a 
significant new use by this rule to notify EPA at least 90 days before 
commencing that activity. The required notification initiates EPA's 
evaluation of the use, under the conditions of use for that chemical 
substance, within the applicable review period. Persons may not 
commence manufacture or processing for the significant new use until 
EPA has conducted a review of the notice, made an appropriate 
determination on the notice, and has taken such actions as are required 
by that determination.

DATES: Comments must be received on or before July 25, 2022.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2021-0568, through the Federal eRulemaking 
Portal at https://www.regulations.gov. Follow the online instructions 
for submitting comments. Do not submit electronically any information 
you consider to be Confidential Business Information (CBI) or other 
information whose disclosure is restricted by statute. Additional 
instructions on commenting or visiting the docket, along with more 
information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: 
    For technical information contact: William Wysong, New Chemicals 
Division (7405M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, 
DC 20460-0001; telephone number: (202) 564-4163; email address: 
[email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: [email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you manufacture, 
process, or use the chemical substances contained in this proposed 
rule. The following list of North American Industrial Classification 
System (NAICS) codes is not intended to be exhaustive, but rather 
provides a guide to help readers determine whether this document 
applies to them. Potentially affected entities may include:
     Manufacturers or processors of one or more subject 
chemical substances (NAICS codes 325 and 324110), e.g., chemical 
manufacturing and petroleum refineries.
    This action may also affect certain entities through pre-existing 
import certification and export notification rules under TSCA. Chemical 
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import 
provisions promulgated at 19 CFR 12.118 through 12.127 and 19 CFR 
127.28. Chemical importers must certify that the shipment of the 
chemical substance complies with all applicable rules and Orders under 
TSCA, which would include the SNUR requirements should these proposed 
rules be finalized. The EPA policy in support of import certification 
appears at 40 CFR part 707, subpart B. In addition, pursuant to 40 CFR 
721.20, any persons who export or intend to export a chemical substance 
that is the subject of this proposed rule on or after July 25, 2022 are 
subject to the export notification provisions of TSCA section 12(b) (15 
U.S.C. 2611(b)) (see 40 CFR 721.20), and must comply with the export 
notification requirements in 40 CFR part 707, subpart D.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov or email. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as 
CBI and then identify electronically within the disk or CD-ROM the 
specific information that is claimed as CBI. In addition to one 
complete version of the comment that includes information claimed as 
CBI, a copy of the comment that does not contain the information 
claimed as CBI must be submitted for inclusion in the public docket. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting 
your comments, see the commenting tips at https://www.epa.gov/dockets/commenting-epa-dockets.

II. Background

A. What action is the Agency taking?

    EPA is proposing these SNURs under TSCA section 5(a)(2) (15 U.S.C. 
2604(a)(2)) for certain chemical substances that were the subject of 
PMNs. These proposed SNURs would require persons to notify EPA at least 
90 days before commencing the manufacture or processing of any of these 
chemical substances for an activity proposed as a significant new use. 
Receipt of such notices would allow EPA to assess risks and, if

[[Page 37784]]

appropriate, to regulate the significant new use before it may occur.
    The docket for these proposed SNURs, identified as docket ID number 
EPA-HQ-OPPT-2021-0568, includes information considered by the Agency in 
developing these proposed SNURs.

B. What is the Agency's authority for taking this action?

    TSCA section 5(a)(2) (15 U.S.C. 2604(a)(2)) authorizes EPA to 
determine that a use of a chemical substance is a ``significant new 
use.'' EPA must make this determination by rule after considering all 
relevant factors, including the four TSCA section 5(a)(2) factors 
listed in Unit III.

C. Applicability of General Provisions

    General provisions for SNURs appear in 40 CFR part 721, subpart A. 
These provisions describe persons subject to the rule, recordkeeping 
requirements, exemptions to reporting requirements, and applicability 
of the rule to uses occurring before the effective date of the rule. 
Provisions relating to user fees appear at 40 CFR part 700. Pursuant to 
40 CFR 721.1(c), persons subject to these SNURs must comply with the 
same significant new use notice (SNUN) requirements and EPA regulatory 
procedures as submitters of PMNs under TSCA section 5(a)(1)(A). These 
requirements include the information submission requirements of TSCA 
sections 5(b) and 5(d)(1), the exemptions authorized by TSCA sections 
5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 
720. Once EPA receives a SNUN and before the manufacture or processing 
for the significant new use can commence, EPA must either determine 
that the use is not likely to present an unreasonable risk of injury 
under the conditions of use for the chemical substance or take such 
regulatory action as is associated with an alternative determination. 
If EPA determines that the use is not likely to present an unreasonable 
risk, EPA is required under TSCA section 5(g) to make public, and 
submit for publication in the Federal Register, a statement of EPA's 
findings.

III. Significant New Use Determination

    TSCA section 5(a)(2) states that EPA's determination that a use of 
a chemical substance is a significant new use must be made after 
consideration of all relevant factors, including:
     The projected volume of manufacturing and processing of a 
chemical substance.
     The extent to which a use changes the type or form of 
exposure of human beings or the environment to a chemical substance.
     The extent to which a use increases the magnitude and 
duration of exposure of human beings or the environment to a chemical 
substance.
     The reasonably anticipated manner and methods of 
manufacturing, processing, distribution in commerce, and disposal of a 
chemical substance.
    In determining what would constitute a significant new use for the 
chemical substances that are the subject of these SNURs, EPA considered 
relevant information about the toxicity of the chemical substances, 
potential human exposures and environmental releases that may be 
associated with possible uses of these chemical substances, in the 
context of the four TSCA section 5(a)(2) factors listed in this unit.
    The proposed rules include PMN substances that are subject to 
Orders issued under TSCA section 5(e)(1)(A), as required by the 
determinations made under TSCA section 5(a)(3)(B). The TSCA Orders 
require protective measures to limit exposures or otherwise mitigate 
the potential unreasonable risk. The proposed SNURs identify 
significant new uses as any manufacturing, processing, use, 
distribution in commerce, or disposal that does not conform to the 
restrictions imposed by the underlying TSCA Orders, consistent with 
TSCA section 5(f)(4).
    Where EPA determined that the PMN substance may present an 
unreasonable risk of injury to human health via inhalation exposure to 
workers, the underlying TSCA Order usually requires that potentially 
exposed employees wear specified respirators unless actual measurements 
of the workplace air show that air-borne concentrations of the PMN 
substance are below a New Chemical Exposure Limit (NCEL), and includes 
requirements addressing performance criteria for sampling and 
analytical methods, periodic monitoring, respiratory protection, and 
recordkeeping. No comparable NCEL provisions currently exist in 40 CFR 
part 721, subpart B, for SNURs. Therefore, for these cases, the 
individual SNURs in 40 CFR part 721, subpart E, will state that persons 
subject to the SNUR who wish to pursue NCELs as an alternative to the 
40 CFR 721.63 respirator requirements may request to do so under 40 CFR 
721.30. EPA expects that persons whose 40 CFR 721.30 requests to use 
the NCELs approach for SNURs are approved by EPA will be required to 
comply with NCELs provisions that are comparable to those contained in 
the corresponding TSCA Order for the same chemical substance.

IV. Substances Subject to This Proposed Rule

    EPA is proposing significant new use and recordkeeping requirements 
for certain chemical substances in 40 CFR part 721, subpart E. In this 
unit, EPA provides the following information for each chemical 
substance that is identified in this unit as subject to this proposed 
rule:
     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 Order.
     Potentially Useful Information.
     CFR citation assigned in the regulatory text section of 
the proposed rule.
    The chemicals subject to these proposed SNURs are as follows:

PMN Number: P-18-143

    Chemical Name: Fatty acids, tall-oil polymers with aminoalkyl, 
dialkyl alkane diamine, polyalkylene polyamine alkanepolyamine 
fraction, and tris-[(alkylamino) alkyl] phenol (generic).
    CAS Number: Not available.
    Effective Date of TSCA Order: April 27, 2021.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the substance will be as an anti-corrosive primer 
for outdoor industrial applications. Based on available data on an 
analogue, EPA has identified concerns for systemic effects and 
reproduction/developmental toxicity. Based on analogue data for the low 
molecular weight fraction and information in the Safety Data Sheet, EPA 
has also identified concerns for corrosion to all tissues and skin 
sensitization. Based on comparison to analogous aliphatic amines, EPA 
predicts that toxicity to aquatic organisms may occur at concentrations 
that exceed 1 ppb. The Order was issued under TSCA sections 
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the 
absence of sufficient information to permit a reasoned evaluation, the 
substance may present an unreasonable risk of injury to human health or 
the environment. To protect against these risks, the Order requires:
     No release of the PMN substance resulting in surface water 
concentrations that exceed 1 ppb; and
     No use of the PMN substance in a consumer product.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.

[[Page 37785]]

    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of aquatic 
toxicity testing may be potentially useful to characterize the 
environmental effects of the PMN substance. Although the Order does not 
require these tests, the Order's restrictions remain in effect until 
the Order is modified or revoked by EPA based on submission of this or 
other relevant information.
    CFR Citation: 40 CFR 721.11687.

PMN Number: P-18-154

    Chemical Name: Isocyanic acid, polyalkylenepolycycloalkylene ester, 
2-alkoxy alkanol and 1-alkoxy alkanol and alkylene diol blocked 
(generic).
    CAS Number: Not available.
    Effective Date of TSCA Order: August 2, 2021.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use will be as a crosslinking agent for coatings. Based 
on the expected function of the PMN substance as a crosslinking agent 
that can crosslink proteins and bind to DNA, EPA has identified 
concerns for skin sensitization, respiratory sensitization, and 
genotoxicity. Based on comparison to analogous carbamate esters, EPA 
predicts that toxicity to aquatic organisms may occur at concentrations 
that exceed 1 ppb. The Order was issued under TSCA sections 
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the 
absence of sufficient information to permit a reasoned evaluation, the 
substance may present an unreasonable risk of injury to human health or 
the environment. To protect against these risks, the Order requires:
     Use of personal protective equipment where there is a 
potential for dermal exposure;
     No use of the PMN substance in a consumer product;
     No manufacture, processing, or use of the PMN substance in 
any manner that results in inhalation exposure;
     Establishment of a hazard communication program, including 
human health and environmental precautionary statements on each label 
and in the SDS; and
     No release of the PMN substance resulting in surface water 
concentrations that exceed 1 ppb.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of genetic 
toxicity, skin sensitization, and aquatic toxicity testing may be 
potentially useful to characterize the health and environmental effects 
of the PMN substance. Although the Order does not require these tests, 
the Order's restrictions remain in effect until the Order is modified 
or revoked by EPA based on submission of this or other relevant 
information.
    CFR Citation: 40 CFR 721.11688.

PMN Number: P-18-273

    Chemical Name: 1,4-Cyclohexanedicarboxylic acid, 1,4-bis(2-
ethylhexyl) ester.
    CAS Number: 84731-70-4.
    Effective Date of TSCA Order: June 9, 2021.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the substance will be for polymer manufacturing. 
Based on test data on the PMN substance, EPA has identified concerns 
for thyroid effects. The Order was issued under TSCA sections 
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the 
absence of sufficient information to permit a reasoned evaluation, the 
substance may present an unreasonable risk of injury to human health. 
To protect against these risks, the Order requires:
     No use of the PMN substance other than the confidential 
use allowed in the Order;
     No domestic manufacture of the PMN substance (i.e., import 
only);
     Use of personal protective equipment where there is a 
potential for dermal exposure; and
     Establishment of a hazard communication program, including 
human health precautionary statements on each label and in the SDS.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of 
toxicokinetics testing may be potentially useful to characterize the 
health effects of the PMN substance. Although the Order does not 
require these tests, the Order's restrictions remain in effect until 
the Order is modified or revoked by EPA based on submission of this or 
other relevant information.
    CFR Citation: 40 CFR 721.11689.

PMN Number: P-18-290

    Chemical Name: Carbomonocylic-oxazolidine (generic).
    CAS Number: Not available.
    Effective Date of TSCA Order: August 19, 2021.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the substance will be for gas scrubbing and 
wastewater deodorizing. Based on the potential release of a hydrolysis 
product of the PMN substance, EPA has identified concerns for systemic 
effects. Based on comparison to analogous chemical substances, EPA has 
identified concerns for eye and respiratory tract irritation. Based on 
test data on the PMN substance, EPA predicts that toxicity to aquatic 
organisms may occur at concentrations that exceed 285 ppb. The Order 
was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), 
based on a finding that in the absence of sufficient information to 
permit a reasoned evaluation, the substance may present an unreasonable 
risk of injury to human health or the environment. To protect against 
these risks, the Order requires:
     Use of personal protective equipment where there is a 
potential for dermal exposure;
     Use of a NIOSH-certified respirator with an APF of at 
least 10 where there is a potential for inhalation exposure;
     Establishment of a hazard communication program, including 
human health and environmental precautionary statements on each label 
and in the SDS; and
     No release of the PMN substance resulting in surface water 
concentrations that exceed 285 ppb.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of eye 
irritation, specific target organ toxicity, and chronic aquatic 
toxicity testing may be potentially useful to characterize the health 
and environmental effects of the PMN substance. Although the Order does 
not require these tests, the Order's

[[Page 37786]]

restrictions remain in effect until the Order is modified or revoked by 
EPA based on submission of this or other relevant information.
    CFR Citation: 40 CFR 721.11690.

PMN Number: P-19-73

    Chemical Name: Propoxylated, ethoxylated alkoxyalkyl ether 
(generic).
    CAS Number: Not available.
    Effective Date of TSCA Order: April 22, 2021.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the substance will be as a polymer coatings 
additive--low foaming wetting agent. Based on the surfactant properties 
and submitted test data on the PMN substance, EPA has identified 
concerns for irritation to the eyes, skin, lungs, and mucous membranes; 
skin sensitization; and lung effects. Based on comparison to 
structurally analogous chemical substances, EPA has also identified 
concerns for systemic toxicity. Based on submitted test data on the PMN 
substance and comparison to analogous nonionic surfactants, EPA 
predicts that toxicity to aquatic organisms may occur at concentrations 
that exceed 24 ppb. The Order was issued under TSCA sections 
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the 
absence of sufficient information to permit a reasoned evaluation, the 
substance may present an unreasonable risk of injury to human health or 
the environment. To protect against these risks, the Order requires:
     Use of personal protective equipment where there is a 
potential for dermal exposure;
     Use of a NIOSH-certified respirator with an APF of at 
least 1,000 where there is a potential for inhalation exposure;
     No processing of the PMN substance for use in consumer 
products unless the concentration in consumer formulations is less than 
1%;
     Establishment of a hazard communication program, including 
human health and environmental precautionary statements on each label 
and in the SDS; and
     No release of the PMN substance resulting in surface water 
concentrations that exceed 24 ppb.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of 
pulmonary effects, eye damage, and specific target organ toxicity 
testing may be potentially useful to characterize the health effects of 
the PMN substance. Although the Order does not require these tests, the 
Order's restrictions remain in effect until the Order is modified or 
revoked by EPA based on submission of this or other relevant 
information.
    CFR Citation: 40 CFR 721.11691.

PMN Number: P-19-98

    Chemical Name: Phosphoric acid, polymer with (hydroxyalkyl)-
alkanediol and alkanediol (generic).
    CAS Number: Not available.
    Effective Date of TSCA Order: May 28, 2021.
    Basis for TSCA Order: The PMN states that use of the substance will 
be as a flame retardant additive for intumescent coatings. Based on 
available data on a residual substance, EPA has identified concerns for 
neurotoxicity, developmental effects, and systemic effects. Based on 
phosphate esters, EPA has also identified concerns for reproductive 
toxicity, neurotoxicity, and systemic effects. Based on phosphoric acid 
residual, EPA has also identified concerns for corrosion to the skin, 
eyes, and respiratory tract. The Order was issued under TSCA sections 
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the 
absence of sufficient information to permit a reasoned evaluation, the 
substance may present an unreasonable risk of injury to human health or 
the environment. To protect against these risks, the Order requires:
     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 where there is a potential for inhalation exposure;
     Establishment of a hazard communication program, including 
human health precautionary statements on each label and in the SDS;
     Use of the PMN substance only as a flame retardant 
additive for intumescent coatings;
     No use of the PMN substance in a consumer product; and
     No release of the PMN substance resulting in surface water 
concentrations that exceed 500 ppb.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of 
neurotoxicity, skin corrosion, eye corrosion, reproductive toxicity, 
and specific target organ toxicity testing may be potentially useful to 
characterize the health effects of the PMN substance. Although the 
Order does not require these tests, the Order's restrictions remain in 
effect until the Order is modified or revoked by EPA based on 
submission of this or other relevant information.
    CFR Citation: 40 CFR 721.11692.

PMN Numbers: P-19-122 and P-20-83

    Chemical Names: 2-Propenoic acid, 2-(hydrogenated animal-based 
nitrogen-substituted)ethyl ester (generic) (P-19-122) and 2-propenoic 
acid, nitrogen-substituted alkyl, N-C16-18-acyl derivs. (generic) (P-
20-83).
    CAS Number: Not available.
    Effective Date of TSCA Order: March 17, 2021.
    Basis for TSCA Order: The PMNs state that the generic (non-
confidential) uses of the substances will be as reactant monomers in a 
polymer for industrial use. Based on the waterproofing properties of 
the PMN substances, EPA has identified concerns for lung effects. Based 
on comparison to structurally analogous chemical substances, EPA has 
also identified concerns for dermal irritation/sensitization, systemic 
toxicity, skin/eye corrosion, systemic effects, developmental toxicity, 
and male reproductive effects. Based on comparison to analogous 
acrylates, EPA predicts that toxicity to aquatic organisms may occur at 
concentrations that exceed 1 ppb. The Order was issued under TSCA 
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding 
that in the absence of sufficient information to permit a reasoned 
evaluation, the substances may present an unreasonable risk of injury 
to human health or the environment. To protect against these risks, the 
Order requires:
     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 where there is a potential for inhalation exposure;
     No domestic manufacture (i.e., import only);
     No use of the PMN substances in consumer applications;
     Establishment of a hazard communication program, including 
human health and environmental precautionary statements on each label 
and in the SDS; and

[[Page 37787]]

     No release of the PMN substances resulting in surface 
water concentrations that exceed 1 ppb.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of chronic 
aquatic toxicity testing may be potentially useful to characterize the 
environmental effects of the PMN substances. Although the Order does 
not require these tests, the Order's restrictions remain in effect 
until the Order is modified or revoked by EPA based on submission of 
this or other relevant information.
    CFR Citations: 40 CFR 721.11693 (P-19-122) and 40 CFR 721.11694 (P-
20-83).

PMN Number: P-20-5

    Chemical Name: Modified graphene (generic).
    CAS Number: Not available.
    Effective Date of TSCA Order: August 13, 2021.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the substance will be as an additive for plastics 
and resins. Based on analogue data, EPA has identified concerns for 
lung effects, immunotoxicity, and eye irritation. EPA was unable to 
estimate the environmental hazard of this new chemical substance. The 
Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient 
information to permit a reasoned evaluation, the substance may present 
an unreasonable risk of injury to human health or the environment. To 
protect against these risks, the Order requires:
     Use of personal protective equipment where there is a 
potential for dermal exposure;
     Use of a NIOSH-certified particulate respirator with an 
APF of at least 50 where there is a potential for inhalation exposure;
     Implementation of dust controls that demonstrate an 
exposure reduction of at least 90% where workers are reasonably 
expected to be exposed by inhalation to dust from the substance;
     No processing or use of the PMN substance other than for 
the confidential use allowed in the Order;
     No domestic manufacture of the PMN substance (i.e., import 
only);
     No use of the PMN substance in an application method that 
results in inhalation exposure to workers;
     No direct release of the PMN substance to air;
     Disposal of the PMN substance only by incineration or 
landfill; and
     No release of the PMN substance to water.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of eye 
irritation, pulmonary effects, specific target organ toxicity, 
carcinogenicity (lung), and aquatic toxicity testing may be potentially 
useful to characterize the health and environmental effects of the PMN 
substance. Although the Order does not require these tests, the Order's 
restrictions remain in effect until the Order is modified or revoked by 
EPA based on submission of this or other relevant information.
    CFR Citation: 40 CFR 721.11695.

PMN Number: P-20-58

    Chemical Name: Polysaccharide, polymer with unsaturated carboxylic 
acid and methacryloxyethyltrimethyl ammonium chloride, sodium salt, 
acid salt initiated (generic).
    CAS Number: Not available.
    Effective Date of TSCA Order: September 9, 2021.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the substance will be as an additive for automatic 
dishwashing and hard surface cleaners. Based on comparison to analogous 
chemical substances, EPA has identified concerns for systemic effects. 
Based on comparison to analogous chemical substances, EPA predicts that 
toxicity to aquatic organisms may occur at concentrations that exceed 
102 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient 
information to permit a reasoned evaluation, the substance may present 
an unreasonable risk of injury to human health or the environment. To 
protect against these risks, the Order requires:
     Use of personal protective equipment where there is a 
potential for dermal exposure;
     Establishment of a hazard communication program, including 
human health and environmental precautionary statements on each label 
and in the SDS; and
     No release of the PMN substance resulting in surface water 
concentrations that exceed 102 ppb.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of 
specific target organ toxicity and aquatic toxicity testing may be 
potentially useful to characterize the health and environmental effects 
of the PMN substance. Although the Order does not require these tests, 
the Order's restrictions remain in effect until the Order is modified 
or revoked by EPA based on submission of this or other relevant 
information.
    CFR Citation: 40 CFR 721.11696.

PMN Numbers: P-20-112, P-20-113, P-20-114, P-20-115, P-20-116, and P-
20-117

    Chemical Names: Ashes (residues), reactions products with 
dicarboxylic acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-
(trialkoxysilyl)alkoxy]methyl]oxirane (generic) (P-20-112), Ashes 
(residues), reactions products with substituted tricarboxylic acid, 
silicic acid (H4SiO4) tetra-Et ester and 2-[[3- 
(trialkoxysilyl)alkoxy]methyl]oxirane (generic) (P-20-113), Ashes 
(residues), reactions products with dicarboxylic acid, silicic acid 
(H4SiO4) tetra-Et ester and 2-[[3-(trialkoxysilyl)alkoxy]methyl]oxirane 
(generic) (P-20-114), Ashes (residues), reactions products with 
substituted tricarboxylic acid, silicic acid (H4SiO4) tetra-Et ester 
and 2-[[3- (trialkoxysilyl)alkoxy]methyl]oxirane (generic) (P-20-115), 
Ashes (residues), reactions products with dicarboxylic acid, silicic 
acid (H4SiO4) tetra-Et ester and 2-[[3-
(trialkoxysilyl)alkoxy]methyl]oxirane (generic) (P-20-116), and Ashes 
(residues), reactions products with dicarboxylic acid, silicic acid 
(H4SiO4) tetra-Et ester and 2-[[3-(trialkoxysilyl)alkoxy]methyl]oxirane 
(generic) (P-20-117).
    CAS Numbers: Not available.
    Effective Date of TSCA Order: June 15, 2021.

[[Page 37788]]

    Basis for TSCA Order: The PMNs state that the use of the substances 
will be as additives for polymers (e.g., rubber, plastics, adhesives, 
coatings and sealants). Based on the metal content of the PMN 
substances, EPA has identified concerns for lung toxicity, acute 
toxicity, lung effects, systemic effects, developmental effects, 
carcinogenicity, and mutagenicity. Based on silica and metal components 
(nickel and vanadium), acid groups, and information in the SDS, EPA has 
identified concerns for irritation and sensitization. The Order was 
issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), 
based on a finding that in the absence of sufficient information to 
permit a reasoned evaluation, the substances may present an 
unreasonable risk of injury to human health. To protect against these 
risks, the Order requires:
     Submittal to EPA of metals content analysis of the 
confidential immediate precursor used to manufacture the PMN 
substances;
     Use of a NIOSH-certified respirator with an APF of at 
least 50 where there is a potential for inhalation exposure or 
compliance with a NCEL of 0.05 mg/m\3\ as an 8-hour time-weighted 
average to prevent inhalation exposure;
     No manufacture, processing, or use of the PMN substances 
other than at facilities equipped with pollution controls, such as a 
bag house, that remove particulates from the air at 99% or greater 
efficiency and ensure all air releases from each facility, including 
fugitive releases, are filtered through these pollution controls;
     Use of the PMN substances only for the uses described in 
the PMNs; and
     Establishment of a hazard communication program, including 
human health precautionary statements on each label and in the SDS.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. The submitter has agreed not to exceed the 
time limits in the Order without sampling and analyzing the 
confidential immediate precursor used to manufacture the PMN substances 
via EPA Method 6010B for the following elements: arsenic, barium, 
beryllium, cadmium, chromium, cobalt, copper, lead, manganese, mercury, 
nickel, selenium, silver, vanadium, and zinc.
    CFR Citations: 40 CFR 721.11697 (P-20-112), 40 CFR 721.11698 (P-20-
113), 40 CFR 721.11699 (P-20-114), 40 CFR 721.11700 (P-20-115), 40 CFR 
721.11701 (P-20-116), and 40 CFR 721.11702 (P-20-117).

PMN Number: P-20-173

    Chemical Name: Silsesquioxanes, alkyl, alkoxy- and hydroxy- 
terminated (generic).
    CAS Number: Not available.
    Effective Date of TSCA Order: June 10, 2021.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the substance will be as a coating additive. Based 
on the reactivity of the PMN substance and a structural alert for 
alkoxysilanes and siloxanes, EPA has identified concerns for irritation 
to the skin, eyes, and respiratory tract and potential lung effects. 
Based on comparison to analogous neutral organics and alkoxysilanes, 
EPA predicts that toxicity to aquatic organisms may occur at 
concentrations that exceed 1 ppb. The Order was issued under TSCA 
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding 
that in the absence of sufficient information to permit a reasoned 
evaluation, the substance may present an unreasonable risk of injury to 
human health or the environment. To protect against these risks, the 
Order requires:
     Use of personal protective equipment where there is a 
potential for dermal exposure;
     Use of a NIOSH-certified respirator with an APF of at 
least 10 where there is a potential for inhalation exposure;
     Establishment of a hazard communication program, including 
human health and environmental precautionary statements on each label 
and in the SDS; and
     No release of the PMN substance resulting in surface water 
concentrations that exceed 1 ppb.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of 
specific target organ toxicity, pulmonary effects, and aquatic toxicity 
testing may be potentially useful to characterize the health and 
environmental effects of the PMN substance. Although the Order does not 
require these tests, the Order's restrictions remain in effect until 
the Order is modified or revoked by EPA based on submission of this or 
other relevant information.
    CFR Citation: 40 CFR 721.11703.

PMN Number: P-21-10

    Chemical Name: 1,3-Benzenedicarboxylic acid, polymer with 2,2-
dimethyl-1,3-propanediol, 1,2-ethanediol, 2-ethyl-2- (hydroxymethyl)- 
1,3-propanediol, hexanedioic acid, 1,6-hexanediol and 1,3-
isobenzofurandione, N-[[1,3,3-trimethyl-5-[[[2-[(1-oxo-2- propen-1-
yl)oxy]ethoxy]carbonyl]amino]cyclohexyl]methyl]carbamate N-[3,3,5-
trimethyl-5-[[[[2-[(1-oxo-2-propen-1- 
yl)oxy]ethoxy]carbonyl]amino]methyl]cyclohexyl]carbamate
    CAS Number: 2460376-09-2.
    Effective Date of TSCA Order: July 1, 2021.
    Basis for TSCA Order: The PMN states that the use of the substance 
will be in 3D printing. Based on structural alerts for acrylates, EPA 
has identified concerns for irritation to the skin, eyes, and 
respiratory tract; and skin sensitization. Based on structural alerts 
for bifunctional acrylates, EPA has identified a concern for 
respiratory sensitization for the low molecular weight species. The 
Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient 
information to permit a reasoned evaluation, the substance may present 
an unreasonable risk of injury to human health or the environment. To 
protect against these risks, the Order requires:
     Use of personal protective equipment where there is a 
potential for dermal exposure;
     No manufacture, processing, or use of the PMN substance in 
any manner that results in inhalation exposure;
     No use of the PMN substance in a consumer product; and
     Establishment of a hazard communication program, including 
human health precautionary statements on each label and in the SDS.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of 
metabolism/pharmacokinetics, pulmonary effects, skin irritation, eye 
irritation, and skin sensitization testing may be potentially useful to 
characterize

[[Page 37789]]

the health effects of the PMN substance. Although the Order does not 
require these tests, the Order's restrictions remain in effect until 
the Order is modified or revoked by EPA based on submission of this or 
other relevant information.
    CFR Citation: 40 CFR 721.11704.

PMN Number: P-21-13

    Chemical Name: Methyl phenylethyl cyclopropanemethanol (generic).
    CAS Number: Not available.
    Effective Date of TSCA Order: May 20, 2021.
    Basis for TSCA Order: The PMN states that use of the substance will 
be as a fragrance in fine fragrances; shampoos and body washes; 
household products such as laundry detergents and air fresheners; and 
deodorants and cosmetics. Based on submitted test data and comparison 
to analogous chemical substances, EPA has identified concerns for skin 
sensitization and irritation to the eyes and respiratory tract. Based 
on comparison to analogous neutral organic chemicals, EPA predicts that 
toxicity to aquatic organisms may occur at concentrations that exceed 1 
ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient 
information to permit a reasoned evaluation, the substance may present 
an unreasonable risk of injury to human health or the environment. To 
protect against these risks, the Order requires:
     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 where there is a potential for inhalation exposure;
     Establishment of a hazard communication program, including 
human health and environmental precautionary statements on each label 
and in the SDS;
     Use of the PMN substance in a consumer product only if the 
concentration of the PMN substance is less than 1%; and
     No release of the PMN substance resulting in surface water 
concentrations that exceed 1 ppb.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of aquatic 
toxicity testing may be potentially useful to characterize the 
environmental effects of the PMN substance. Although the Order does not 
require these tests, the Order's restrictions remain in effect until 
the Order is modified or revoked by EPA based on submission of this or 
other relevant information.
    CFR Citation: 40 CFR 721.11705.

PMN Number: P-21-17

    Chemical Name: [(Substituted-carbomonocyclic)amino] oxoalkenoic 
acid, inorganic salt (generic).
    CAS Number: Not available.
    Effective Date of TSCA Order: June 16, 2021.
    Basis for TSCA Order: The PMN states that the use of the substance 
will be to improve physical properties in rubber products. Based on 
submitted test data, EPA has identified concerns for systemic effects 
and skin sensitization. Based on submitted test data, EPA predicts that 
toxicity to aquatic organisms may occur at concentrations that exceed 
590 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient 
information to permit a reasoned evaluation, the substance may present 
an unreasonable risk of injury to human health or the environment. To 
protect against these risks, the Order requires:
     Use of personal protective equipment where there is a 
potential for dermal exposure;
     Use of a NIOSH-certified particulate respirator with an 
APF of at least 50 where there is a potential for inhalation exposure;
     No domestic manufacture of the PMN substance (i.e., import 
only);
     No use of the PMN substance other than as an additive to 
improve physical properties in rubber products; and
     Establishment of a hazard communication program, including 
human health precautionary statements on each label and in the SDS.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of 
specific target organ toxicity and skin sensitization testing may be 
potentially useful to characterize the health effects of the PMN 
substance. Although the Order does not require these tests, the Order's 
restrictions remain in effect until the Order is modified or revoked by 
EPA based on submission of this or other relevant information.
    CFR Citation: 40 CFR 721.11706.

PMN Number: P-21-18

    Chemical Name: Sulfonium, triphenyl-, heterocyclic compound-
carboxylate (1:1) (generic).
    CAS Number: Not available.
    Effective Date of TSCA Order: March 24, 2021.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the substance will be for contained use for 
microlithography for electronic device manufacturing. Based on the 
physical/chemical properties of the PMN substance (as described in the 
New Chemical Program's PBT category at 64 FR 60194; November 1999) and 
test data on structurally similar substances, the PMN substance is a 
potentially persistent, bioaccumulative, and toxic (PBT) chemical. EPA 
estimates that the PMN substance will persist in the environment for 
more than 2 months and estimates a bioaccumulation factor of greater 
than or equal to 1,000. Based on the photoreactivity of the PMN 
substance, EPA has identified concerns for photosensitization. Based on 
comparison to analogous substances, EPA has identified concerns for eye 
corrosion, irritation, acute toxicity, liver toxicity, neurotoxicity, 
and reproductive (developmental) toxicity. The Order was issued under 
TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a 
finding that in the absence of sufficient information to permit a 
reasoned evaluation, the substance may present an unreasonable risk of 
injury to human health or the environment. To protect against these 
risks, the Order requires:
     No manufacture of the PMN substance beyond the time limits 
specified in the Order without submittal to EPA the results of certain 
testing described in the Testing section of the Order;
     Use of personal protective equipment where there is a 
potential for dermal exposure;
     Establishment of a hazard communication program, including 
human health and environmental precautionary statements on each label 
and in the SDS;
     No modification of the processing or use of the PMN 
substance in any way that generates a vapor, dust, mist, or aerosol in 
a non-enclosed process;
     Use of the PMN substance only as described in the PMN;

[[Page 37790]]

     No domestic manufacture of the PMN substance (i.e., import 
only);
     Import of the PMN substance only in solution, or in any 
form in sealed containers weighing 5 kilograms or less; and
     No exceedance of the confidential annual importation 
volume listed the Order.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information about the physical/chemical properties, fate, 
bioaccumulation, environmental hazard, and human health effects of the 
PMN substance may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. The submitter has agreed not to exceed the 
time limits specified in the Order without performing the required Tier 
I and Tier II testing outlined in the Testing section of the Order.
    CFR Citation: 40 CFR 721.11707.

PMN Numbers: P-21-23 and P-21-64

    Chemical Names: Sulfonium, carbocyclic-, salt with 1-(alkyl) 2-[4-
[polyhydro-2-carbomonocyclic-5-(polyfluoro-2-sulfoalkyl)-4,7-methano-
1,3-benzodioxol-2-yl]carbomonocyclic oxy]acetate (1:1) (generic) (P-21-
23) and sulfonium, triphenyl-, polyfluoro-polyhydrospiro[9H-
carbopolycyclic-9,2'-[4,7]methano[1,3]benzodioxole]-5'-alkenesulfonic 
acid (1:1) (generic) (P-21-64).
    CAS Numbers: Not available.
    Effective Date of TSCA Order: April 20, 2021.
    Basis for TSCA Order: The PMNs state that the generic (non-
confidential) use of the substances will be for photolithography. Based 
on the physical/chemical properties of the PMN substances (as described 
in the New Chemical Program's PBT category at 64 FR 60194; November 
1999) and test data on structurally similar substances, the PMN 
substances are potentially persistent, bioaccumulative, and toxic (PBT) 
chemicals. EPA estimates that the PMN substances will persist in the 
environment for more than 2 months and estimates a bioaccumulation 
factor of greater than or equal to 1,000. Based on the photoreactivity 
of the PMN substances, EPA has identified concerns for 
photosensitization. Based on comparison to analogous substances, EPA 
has identified concerns for eye corrosion, irritation, acute toxicity, 
liver toxicity, and neurotoxicity. Based on positive mutagenicity and 
the perfluoro anion analogue, EPA has identified concerns for 
reproductive (developmental) toxicity. The Order was issued under TSCA 
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding 
that in the absence of sufficient information to permit a reasoned 
evaluation, the substances may present an unreasonable risk of injury 
to human health or the environment. To protect against these risks, the 
Order requires:
     No manufacture of the PMN substances beyond the time 
limits specified in the Order without submittal to EPA the results of 
certain testing described in the Testing section of the Order;
     Use of personal protective equipment where there is a 
potential for dermal exposure;
     Establishment of a hazard communication program, including 
human health and environmental precautionary statements on each label 
and in the SDS;
     No modification of the processing or use of the PMN 
substances in any way that generates a vapor, dust, mist, or aerosol in 
a non-enclosed process;
     Use of the PMN substances only as described in the PMNs;
     No domestic manufacture of the PMN substances (i.e., 
import only);
     Import of the PMN substances only in solution, or in any 
form in sealed containers weighing 5 kilograms or less; and
     No exceedance of the confidential annual importation 
volumes listed the Order.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information about the physical/chemical properties, fate, 
bioaccumulation, environmental hazard, and human health effects of the 
PMN substances may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. The submitter has agreed not to exceed the 
time limits specified in the Order without performing the required Tier 
I and Tier II testing outlined in the Testing section of the Order.
    CFR Citations: 40 CFR 721.11708 (P-21-23) and 40 CFR 721.11709 (P-
21-64).

PMN Number: P-21-27

    Chemical Name: Heteropolycyclic, trihaloalkyl carbomonocycle-, 
hydroxy carbomonocyclic salt (generic).
    CAS Number: Not available.
    Effective Date of TSCA Order: April 20, 2021.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the substance will be as an ingredient used in the 
manufacture of photoresists. Based on the physical/chemical properties 
of the PMN substance (as described in the New Chemical Program's PBT 
category at 64 FR 60194; November 1999) and test data on structurally 
similar substances, the PMN substance is a potentially persistent, 
bioaccumulative, and toxic (PBT) chemical. EPA estimates that the PMN 
substance will persist in the environment for more than 2 months and 
estimates a bioaccumulation factor of greater than or equal to 1,000. 
Based on the photoreactivity of the PMN substance, EPA has identified 
concerns for photosensitization. Based on comparison to analogous 
substances, EPA has identified concerns for eye corrosion, irritation, 
acute toxicity, liver toxicity, neurotoxicity, and reproductive 
(developmental) toxicity. The Order was issued under TSCA sections 
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the 
absence of sufficient information to permit a reasoned evaluation, the 
substance may present an unreasonable risk of injury to human health or 
the environment. To protect against these risks, the Order requires:
     No manufacture of the PMN substance beyond the time limits 
specified in the Order without submittal to EPA the results of certain 
testing described in the Testing section of the Order;
     Use of personal protective equipment where there is a 
potential for dermal exposure;
     Establishment of a hazard communication program, including 
human health and environmental precautionary statements on each label 
and in the SDS;
     No modification of the processing or use of the PMN 
substance in any way that generates a vapor, dust, mist, or aerosol in 
a non-enclosed process;
     Use of the PMN substance only as described in the PMN;
     No domestic manufacture of the PMN substance (i.e., import 
only);
     Import of the PMN substance only in solution, or in any 
form in sealed containers weighing 5 kilograms or less; and

[[Page 37791]]

     No exceedance of the confidential annual importation 
volume listed the Order.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information about the physical/chemical properties, fate, 
bioaccumulation, environmental hazard, and human health effects of the 
PMN substance may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. The submitter has agreed not to exceed the 
time limits specified in the Order without performing the required Tier 
I and Tier II testing outlined in the Testing section of the Order.
    CFR Citation: 40 CFR 721.11710.

PMN Number: P-21-42

    Chemical Name: Sulfonium, tricarbocyclic-, 2-heteroatom-
substituted-4-(alkyl)carbomonocyclic carboxylate (1:1) (generic).
    CAS Number: Not available.
    Effective Date of TSCA Order: April 1, 2021.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the substance will be for photolithography. Based 
on the physical/chemical properties of the PMN substance (as described 
in the New Chemical Program's PBT category at 64 FR 60194; November 
1999) and test data on structurally similar substances, the PMN 
substance is a potentially persistent, bioaccumulative, and toxic (PBT) 
chemical. EPA estimates that the PMN substance will persist in the 
environment for more than 2 months and estimates a bioaccumulation 
factor of greater than or equal to 1,000. Based on the photoreactivity 
of the PMN substance, EPA has identified concerns for 
photosensitization. Based on comparison to analogous substances, EPA 
has identified concerns for eye corrosion, irritation, acute toxicity, 
liver toxicity, neurotoxicity, and reproductive (developmental) 
toxicity. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) 
and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of 
sufficient information to permit a reasoned evaluation, the substance 
may present an unreasonable risk of injury to human health or the 
environment. To protect against these risks, the Order requires:
     No manufacture of the PMN substance beyond the time limits 
specified in the Order without submittal to EPA the results of certain 
testing described in the Testing section of the Order;
     Use of personal protective equipment where there is a 
potential for dermal exposure;
     Establishment of a hazard communication program, including 
human health and environmental precautionary statements on each label 
and in the SDS;
     No modification of the processing or use of the PMN 
substance in any way that generates a vapor, dust, mist, or aerosol in 
a non-enclosed process;
     Use of the PMN substance only as described in the PMN;
     No domestic manufacture of the PMN substance (i.e., import 
only);
     Import of the PMN substance only in solution, or in any 
form in sealed containers weighing 5 kilograms or less; and
     No exceedance of the confidential annual importation 
volume listed the Order.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information about the physical/chemical properties, fate, 
bioaccumulation, environmental hazard, and human health effects of the 
PMN substance may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. The submitter has agreed not to exceed the 
time limits specified in the Order without performing the required Tier 
I and Tier II testing outlined in the Testing section of the Order.
    CFR Citation: 40 CFR 721.11711.

PMN Number: P-21-54

    Chemical Name: 2-Propenoic acid, 2-methyl-, aminoalkyl ester, 
polymer with hydroxyalkyl alkenoate and octadecyl alkenoate, acetate 
(salts) (generic).
    CAS Number: Not available.
    Effective Date of TSCA Order: July 23, 2021.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the substance will be as a carpet treatment 
additive. Based on structure alerts, EPA has identified concerns for 
lung waterproofing and irritation to the skin, eyes, and respiratory 
tract. Based on comparison to analogous polycationic polymers, EPA 
predicts that toxicity to aquatic organisms may occur at concentrations 
that exceed 52 ppb. The Order was issued under TSCA sections 
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the 
absence of sufficient information to permit a reasoned evaluation, the 
substance may present an unreasonable risk of injury to human health or 
the environment. To protect against these risks, the Order requires:
     Use of personal protective equipment where there is a 
potential for dermal exposure;
     No use of the PMN substance in a product that is applied 
by a consumer;
     No manufacture or processing of the PMN substance in any 
manner that results in inhalation exposure;
     No use of the PMN substance in an application method that 
results in inhalation exposure;
     Establishment of a hazard communication program, including 
human health and environmental precautionary statements on each label 
and in the SDS; and
     No release of the PMN substance resulting in surface water 
concentrations that exceed 52 ppb.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of 
specific target organ toxicity, skin irritation, eye irritation, and 
aquatic toxicity testing may be potentially useful to characterize the 
health and environmental effects of the PMN substance. Although the 
Order does not require these tests, the Order's restrictions remain in 
effect until the Order is modified or revoked by EPA based on 
submission of this or other relevant information.
    CFR Citation: 40 CFR 721.11712.

PMN Number: P-21-63

    Chemical Name: Heterocyclic-polycarboxylic acid, polyhaloaryl-
polyhydro-alkyl-polyalkyl ester (generic).
    CAS Number: Not available.
    Effective Date of TSCA Order: August 10, 2021.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the substance will be as a component in 
herbicides. Based on test data on the PMN substance, EPA has identified 
concerns for acute toxicity, phototoxicity (skin irritation), 
reproductive effects, and developmental effects. Based on test data on 
the PMN substance, EPA predicts that toxicity to

[[Page 37792]]

aquatic organisms may occur at concentrations that exceed 18 ppb. The 
Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient 
information to permit a reasoned evaluation, the substance may present 
an unreasonable risk of injury to human health or the environment. To 
protect against these risks, the Order requires:
     Use of personal protective equipment where there is a 
potential for dermal exposure;
     No use of the PMN substance in a consumer product;
     Establishment of a hazard communication program, including 
human health and environmental precautionary statements on each label 
and in the SDS; and
     No release of the PMN substance to water.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of aquatic 
toxicity testing may be potentially useful to characterize the 
environmental effects of the PMN substance. Although the Order does not 
require these tests, the Order's restrictions remain in effect until 
the Order is modified or revoked by EPA based on submission of this or 
other relevant information.
    CFR Citation: 40 CFR 721.11713.

PMN Number: P-21-65

    Chemical Name: Alkenoic acid, reaction products with alkylamine-
alkanediyl diacrylate polymer and [oxybis(alkylene)]bis[alkyl-
alkanediol] (generic).
    CAS Number: Not available.
    Effective Date of TSCA Order: June 21, 2021.
    Basis for TSCA Order: The PMN states that the use of the substance 
will be to improve the reactivity of ink formulation when cured under 
LED UV light. Based on structural alerts for cationic binding and for 
acrylates, EPA has identified concerns for lung effects and skin and 
eye irritation. The Order was issued under TSCA sections 
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the 
absence of sufficient information to permit a reasoned evaluation, the 
substance may present an unreasonable risk of injury to human health. 
To protect against these risks, the Order requires:
     Use of personal protective equipment where there is a 
potential for dermal exposure;
     Use of a NIOSH-certified particulate respirator with an 
APF of at least 1,000 where there is a potential for inhalation 
exposure;
     No use of the PMN substance in a spray application;
     No use of the PMN substance in a consumer product; and
     Establishment of a hazard communication program, including 
human health precautionary statements on each label and in the SDS.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of 
specific target organ toxicity, pulmonary effects, skin irritation, eye 
damage, and skin sensitization testing may be potentially useful to 
characterize the health effects of the PMN substance. Although the 
Order does not require these tests, the Order's restrictions remain in 
effect until the Order is modified or revoked by EPA based on 
submission of this or other relevant information.
    CFR Citation: 40 CFR 721.11714.

PMN Number: P-21-125

    Chemical Name: Nonane, branched.
    CAS Number: 85408-10-2.
    Effective Date of TSCA Order: September 17, 2021.
    Basis for TSCA Order: The PMN states that the generic (non-
confidential) use of the substance will be for contained use for 
microlithography for electronic device manufacturing. Based on the 
physical/chemical properties of an analogue, isooctane, EPA has 
identified concerns for aspiration. Based on test data for an analogue 
of a potential metabolite, EPA has identified concerns for skin 
irritation, eye irritation, and systemic, reproductive, and 
developmental effects. Based on comparison to analogous neutral organic 
substances, EPA predicts that toxicity to aquatic organisms may occur 
at concentrations that exceed 5 ppb. The Order was issued under TSCA 
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding 
that in the absence of sufficient information to permit a reasoned 
evaluation, the substance may present an unreasonable risk of injury to 
human health or the environment. To protect against these risks, the 
Order requires:
     Use of personal protective equipment where there is a 
potential for dermal exposure;
     Use of a NIOSH-certified particulate respirator with an 
APF of at least 50 where there is a potential for inhalation exposure 
or compliance with a NCEL of 0.72 mg/m3 as an 8-hour time-weighted 
average to prevent inhalation exposure;
     No use of the PMN substance other than for the 
confidential use allowed in the Order;
     Establishment of a hazard communication program, including 
human health and environmental precautionary statements on each label 
and in the SDS; and
     No release of the PMN substance to water.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially Useful Information: EPA has determined that certain 
information may be potentially useful in support of a request by the 
PMN submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of eye 
damage, reproductive toxicity, skin irritation, specific target organ 
toxicity, and aquatic toxicity testing may be potentially useful to 
characterize the health and environmental effects of the PMN substance. 
Although the Order does not require these tests, the Order's 
restrictions remain in effect until the Order is modified or revoked by 
EPA based on submission of this or other relevant information.
    CFR Citation: 40 CFR 721.11715.

V. Rationale and Objectives of the Proposed Rule

A. Rationale

    During review of the PMNs submitted for the chemical substances 
that are the subject to these proposed SNURs, EPA concluded that 
regulation was warranted under TSCA section 5(e), pending the 
development of information sufficient to make reasoned evaluations of 
the health or environmental effects of the chemical substances. The 
basis for such findings is outlined in Unit IV. Based on these 
findings, TSCA section 5(e) Orders requiring the use of appropriate 
exposure controls were negotiated with the PMN submitters. As a general 
matter, EPA believes it is necessary to follow the TSCA Orders with a 
SNUR that identifies the absence of those protective measures as

[[Page 37793]]

significant new uses to ensure that all manufacturers and processors--
not just the original submitter--are held to the same standard.

B. Objectives

    EPA is proposing these SNURs for specific chemical substances which 
have undergone premanufacture review because the Agency wants:
     To identify as significant new uses any manufacturing, 
processing, use, distribution in commerce, or disposal that does not 
conform to the restrictions imposed by the underlying TSCA Orders, 
consistent with TSCA section 5(f)(4).
     To have an opportunity to review and evaluate data 
submitted in a SNUN before the notice submitter begins manufacturing or 
processing a listed chemical substance for the described significant 
new use.
     To be able to either determine that the prospective 
manufacture or processing is not likely to present an unreasonable 
risk, or to take necessary regulatory action associated with any other 
determination, before the described significant new use of the chemical 
substance occurs.

VI. Applicability of the Proposed Significant New Use Designation

    To establish a significant new use, EPA must determine that the use 
is not ongoing. The chemical substances subject to this proposed rule 
have undergone premanufacture review. In cases where EPA has not 
received a notice of commencement (NOC) and the chemical substance has 
not been added to the TSCA Inventory, no person may commence such 
activities without first submitting a PMN. Therefore, for chemical 
substances for which an NOC has not been submitted EPA concludes that 
the designated significant new uses are not ongoing.
    When chemical substances identified in this proposed rule are added 
to the TSCA Inventory, EPA recognizes that, before the rule is 
effective, other persons might engage in a use that has been identified 
as a significant new use. However, TSCA Orders have been issued for 
these chemical substances, and the PMN submitters are prohibited by the 
TSCA Orders from undertaking activities which would be designated as 
significant new uses. The identities of many of the chemical substances 
subject to this proposed rule have been claimed as confidential per 40 
CFR 720.85. Based on this, the Agency believes that it is highly 
unlikely that any of the significant new uses described in the 
regulatory text of this proposed rule are ongoing.
    Therefore, EPA designates June 24, 2022 as the cutoff date for 
determining whether the new use is ongoing. The objective of EPA's 
approach is to ensure that a person cannot defeat a SNUR by initiating 
a significant new use before the effective date of the final rule.
    In the unlikely event that a person began commercial manufacture or 
processing of the chemical substances for a significant new use 
identified as of that cutoff date, they would have to cease any such 
activity upon the effective date of the final rule. To resume their 
activities, these persons would have to first comply with all 
applicable SNUR notification requirements and wait until EPA has 
conducted a review of the notice, made an appropriate determination on 
the notice, and has taken such actions as are required with that 
determination.
    Issuance of a SNUR for a chemical substance does not signify that 
the chemical substance is listed on the TSCA Chemical Substance 
Inventory (TSCA Inventory). Guidance on how to determine if a chemical 
substance is on the TSCA Inventory is available on the internet at 
https://www.epa.gov/tsca-inventory.

VII. Development and Submission of Information

    EPA recognizes that TSCA section 5 does not require developing any 
particular new information (e.g., generating test data) before 
submission of a SNUN. There is an exception: If a person is required to 
submit information for a chemical substance pursuant to a rule, TSCA 
Order or consent agreement under TSCA section 4, then TSCA section 
5(b)(1)(A) requires such information to be submitted to EPA at the time 
of submission of the SNUN.
    In the absence of a rule, TSCA Order, or consent agreement under 
TSCA section 4 covering the chemical substance, persons are required 
only to submit information in their possession or control and to 
describe any other information known or reasonably ascertainable (see 
40 CFR 720.50). However, upon review of PMNs and SNUNs, the Agency has 
the authority to require appropriate testing. Unit IV. lists 
potentially useful information for the SNURs listed in this document. 
Descriptions of this information is provided for informational 
purposes. The potentially useful information identified in Unit IV. 
will be useful to EPA's evaluation in the event that someone submits a 
SNUN for the significant new use.
    EPA strongly encourages persons, before performing any testing, to 
consult with the Agency. Furthermore, pursuant to TSCA section 4(h), 
which pertains to reduction of testing in vertebrate animals, EPA 
encourages dialog with the Agency on the use of alternative test 
methods and strategies (also called New Approach Methodologies, or 
NAMs), if available, to generate the recommended test data. EPA 
encourages dialog with Agency representatives to help determine how 
best the submitter can meet both the data needs and the objective of 
TSCA section 4(h). For more information on alternative test methods and 
strategies to reduce vertebrate animal testing, visit https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/alternative-test-methods-and-strategies-reduce.
    In some of the TSCA Orders for the chemical substances identified 
in this proposed rule, EPA has established time limits in view of the 
lack of data on the potential health and environmental risks that may 
be posed by the significant new uses or increased exposure to the 
chemical substances. These limits cannot be exceeded unless the PMN 
submitter first submits the results of specified tests that would 
permit a reasoned evaluation of the potential risks posed by these 
chemical substances. The SNURs contain the same time limits as the TSCA 
Orders. Exceeding these production limits is defined as a significant 
new use. Persons who intend to exceed the time limit must notify the 
Agency by submitting a SNUN at least 90 days in advance of commencement 
of non-exempt commercial manufacture or processing.
    Any request by EPA for the triggered and pended testing described 
in the TSCA Orders was made based on EPA's consideration of available 
screening-level data, if any, as well as other available information on 
appropriate testing for the PMN substances. Further, any such testing 
request on the part of EPA that includes testing on vertebrates was 
made after consideration of available toxicity information, 
computational toxicology and bioinformatics, and high-throughput 
screening methods and their prediction models.
    The potentially useful information listed in Unit IV. may not be 
the only means of addressing the potential risks of the chemical 
substance. However, submitting a SNUN without any test data or other 
information may increase the likelihood that EPA will take action under 
TSCA section 5(e) or 5(f). EPA recommends that potential SNUN 
submitters contact EPA early enough so that they will be able to 
conduct the appropriate tests.

[[Page 37794]]

    SNUN submitters should be aware that EPA will be better able to 
evaluate SNUNs which provide detailed information on the following:
     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/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.

IX. Economic Analysis

    EPA has evaluated the potential costs of establishing SNUN 
requirements for potential manufacturers and processors of the chemical 
substances subject to this proposed rule. EPA's complete economic 
analysis is available in the docket for this rulemaking.

X. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive orders 
can be found at https://www.epa.gov/laws-regulations-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive 
Order 13563: Improving Regulations and Regulatory Review

    This action proposes to establish SNURs for several new chemical 
substances that were the subject of PMNs. The Office of Management and 
Budget (OMB) has exempted these types of actions from review under 
Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 
3821, January 21, 2011).

B. Paperwork Reduction Act (PRA)

    According to the PRA (44 U.S.C. 3501 et seq.), an agency may not 
conduct or sponsor, and a person is not required to respond to a 
collection of information that requires OMB approval under PRA, unless 
it has been approved by OMB and displays a currently valid OMB control 
number. The OMB control numbers for EPA's regulations in title 40 of 
the CFR, after appearing in the Federal Register, are listed in 40 CFR 
part 9, and included on the related collection instrument or form, if 
applicable.
    The information collection activities associated with SNURs have 
already been approved by OMB under the PRA and assigned OMB control 
number 2070-0012 (EPA ICR No. 574). This proposed rule does not contain 
any burden requiring additional OMB approval. If an entity were to 
submit a SNUN to the Agency, the annual burden is estimated to average 
between 30 and 170 hours per response. This burden estimate includes 
the time needed to review instructions, search existing data sources, 
gather and maintain the data needed, and complete, review, and submit 
the required SNUN.
    Send any comments about the accuracy of the burden estimate, and 
any suggested methods for minimizing respondent burden, including using 
automated collection techniques, to the Director, Regulatory Support 
Division, Office of Mission Support (2822T), Environmental Protection 
Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001. Please 
remember to include the OMB control number in any correspondence, but 
do not submit any completed forms to this address.

C. Regulatory Flexibility Act (RFA)

    Pursuant to the RFA section 605(b) (5 U.S.C. 601 et seq.), the 
Agency hereby certifies that promulgation of these SNURs would not have 
a significant adverse economic impact on a substantial number of small 
entities. The requirement to submit a SNUN applies to any person 
(including small or large entities) who intends to engage in any 
activity described in the final rule as a ``significant new use.'' 
Because these uses are ``new,'' based on all information currently 
available to EPA, it appears that no small or large entities presently 
engage in such activities. A SNUR requires that any person who intends 
to engage in such activity in the future must first notify EPA by 
submitting a SNUN. EPA's experience to date is that, in response to the 
promulgation of SNURs covering over 1,000 chemicals, the Agency 
receives only a small number of notices per year. For example, the 
number of SNUNs received was seven in Federal fiscal year (FY) 2013, 13 
in FY2014, six in FY2015, 10 in FY2016, 14 in FY2017, and 18 in FY2018 
and only a fraction of these were from small businesses. In addition, 
the Agency currently offers relief to qualifying small businesses by 
reducing the SNUN submission fee from $16,000 to $2,800. This lower fee 
reduces the total reporting and recordkeeping of cost of submitting a 
SNUN to about $10,116 for qualifying small firms. Therefore, the 
potential economic impacts of complying with this proposed SNUR are not 
expected to be significant or adversely impact a substantial number of 
small entities. In a SNUR that published in the Federal Register of 
June 2, 1997 (62 FR 29684) (FRL-5597-1), the Agency presented its 
general determination that final SNURs are not expected to have a 
significant economic impact on a substantial number of small entities, 
which was provided to the Chief Counsel for Advocacy of the Small 
Business Administration.

D. Unfunded Mandates Reform Act (UMRA)

    Based on EPA's experience with proposing and finalizing SNURs, 
State, local, and Tribal governments have not been impacted by these 
rulemakings, and EPA does not have any reasons to believe that any 
State, local, or Tribal government will be impacted by this action. As 
such, EPA has determined that this proposed rule would not impose any 
enforceable duty, contain any unfunded mandate, or otherwise have any 
effect on small governments subject to the requirements of UMRA 
sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.).

E. Executive Order 13132: Federalism

    This action would not have a substantial direct effect on States, 
on the relationship between the National Government and the States, or 
on the distribution of power and responsibilities among the various 
levels of government, as specified in Executive Order 13132 (64 FR 
43255, August 10, 1999).

F. Executive Order 13175: Consultation and Coordination With Indian 
Tribal Governments

    This action would not have Tribal implications because it is not 
expected to have substantial direct effects on Indian Tribes. This 
action would not significantly nor uniquely affect the communities of 
Indian Tribal governments, nor would it involve or impose any 
requirements that affect Indian Tribes. Accordingly, the requirements 
of Executive Order 13175 (65 FR 67249, November 9, 2000), do not apply 
to this action.

[[Page 37795]]

G. Executive Order 13045: Protection of Children From Environmental 
Health Risks and Safety Risks

    This action is not subject to Executive Order 13045 (62 FR 19885, 
April 23, 1997), because this is not an economically significant 
regulatory action as defined by Executive Order 12866, and this action 
does not address environmental health or safety risks 
disproportionately affecting children.

H. Executive Order 13211: Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use

    This action is not subject to Executive Order 13211 (66 FR 28355, 
May 22, 2001), because this proposed rule is not expected to affect 
energy supply, distribution, or use.

I. National Technology Transfer and Advancement Act (NTTAA)

    This action does not involve any technical standards subject to 
NTTAA section 12(d) (15 U.S.C. 272 note).

J. Executive Order 12898: Federal Actions To Address Environmental 
Justice in Minority Populations and Low-Income Populations

    This action does not entail special considerations of environmental 
justice related issues as delineated by Executive Order 12898 (59 FR 
7629, February 16, 1994).

List of Subjects in 40 CFR Part 721

    Environmental protection, Chemicals, Hazardous substances, 
Reporting and recordkeeping requirements.

    Dated: June 15, 2022.
Tala Henry,
Deputy Director, Office of Pollution Prevention and Toxics.

    Therefore, for the reasons stated in the preamble, EPA proposes to 
amend 40 CFR chapter I as set forth below:

PART 721--SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES

0
1. The authority citation for part 721 continues to read as follows:

    Authority: 15 U.S.C. 2604, 2607, and 2625(c).

0
2. Add Sec. Sec.  721.11687 through 721.11715 to subpart E to read as 
follows:

Subpart E--Significant New Uses for Specific Chemical Substances

Sec.
* * * * *
721.11687 Fatty acids, tall-oil polymers with aminoalkyl, dialkyl 
alkane diamine, polyalkylene polyamine alkanepolyamine fraction, and 
tris-[(alkylamino) alkyl] phenol (generic).
721.11688 Isocyanic acid, polyalkylenepolycycloalkylene ester, 2-
alkoxy alkanol and 1-alkoxy alkanol and alkylene diol blocked 
(generic).
721.11689 1,4-Cyclohexanedicarboxylic acid, 1,4-bis(2-ethylhexyl) 
ester.
721.11690 Carbomonocylic-oxazolidine (generic).
721.11691 Propoxylated, ethoxylated alkoxyalkyl ether (generic).
721.11692 Phosphoric acid, polymer with (hydroxyalkyl)-alkanediol 
and alkanediol (generic).
721.11693 2-Propenoic acid, 2-(hydrogenated animal-based nitrogen-
substituted)ethyl ester.
721.11694 2-Propenoic acid, nitrogen-substituted alkyl, N-C16-18-
acyl derivs. (generic).
721.11695 Modified graphene (generic).
721.11696 Polysaccharide, polymer with unsaturated carboxylic acid 
and methacryloxyethyltrimethyl ammonium chloride, sodium salt, acid 
salt initiated (generic).
721.11697 Ashes (residues), reactions products with dicarboxylic 
acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-
(trialkoxysilyl)alkoxy]methyl]oxirane (generic) (P-20-112)
721.11698 Ashes (residues), reactions products with substituted 
tricarboxylic acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-
(trialkoxysilyl)alkoxy]methyl]oxirane (generic) (P-20-113)
721.11699 Ashes (residues), reactions products with dicarboxylic 
acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-
(trialkoxysilyl)alkoxy]methyl]oxirane (generic) (P-20-114)
721.11700 Ashes (residues), reactions products with substituted 
tricarboxylic acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-
(trialkoxysilyl)alkoxy]methyl]oxirane (generic) (P-20-115)
721.11701 Ashes (residues), reactions products with dicarboxylic 
acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-
(trialkoxysilyl)alkoxy]methyl]oxirane (generic) (P-20-116)
721.11702 Ashes (residues), reactions products with dicarboxylic 
acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-
(trialkoxysilyl)alkoxy]methyl]oxirane (generic) (P-20-117)
721.11703 Silsesquioxanes, alkyl, alkoxy- and hydroxy- terminated 
(generic).
721.11704 1,3-Benzenedicarboxylic acid, polymer with 2,2-dimethyl-
1,3-propanediol, 1,2-ethanediol, 2-ethyl-2- (hydroxymethyl)- 1,3-
propanediol, hexanedioic acid, 1,6-hexanediol and 1,3-
isobenzofurandione, N-[[1,3,3-trimethyl-5-[[[2-[(1-oxo-2- propen-1-
yl)oxy]ethoxy]carbonyl]amino]cyclohexyl]methyl]carbamate N-[3,3,5-
trimethyl-5-[[[[2-[(1-oxo-2-propen-1- 
yl)oxy]ethoxy]carbonyl]amino]methyl]cyclohexyl]carbamate.
721.11705 Methyl phenylethyl cyclopropanemethanol (generic).
721.11706 [(Substituted-carbomonocyclic)amino] oxoalkenoic acid, 
inorganic salt (generic).
721.11707 Sulfonium, triphenyl-, heterocyclic compound-carboxylate 
(1:1) (generic).
721.11708 Sulfonium, carbocyclic-, salt with 1-(alkyl) 2-[4-
[polyhydro-2-carbomonocyclic-5-(polyfluoro-2-sulfoalkyl)-4,7-
methano-1,3-benzodioxol-2-yl]carbomonocyclic oxy]acetate (1:1) 
(generic).
721.11709 Sulfonium, triphenyl-, polyfluoro-polyhydrospiro[9H-
carbopolycyclic-9,2'-[4,7]methano[1,3]benzodioxole]-5'-
alkenesulfonic acid (1:1) (generic).
721.11710 Heteropolycyclic, trihaloalkyl carbomonocycle-, hydroxy 
carbomonocyclic salt (generic).
721.11711 Sulfonium, tricarbocyclic-, 2-heteroatom-substituted-4-
(alkyl)carbomonocyclic carboxylate (1:1) (generic).
721.11712 2-Propenoic acid, 2-methyl-, aminoalkyl ester, polymer 
with hydroxyalkyl alkenoate and octadecyl alkenoate, acetate (salts) 
(generic).
721.11713 Heterocyclic-polycarboxylic acid, polyhaloaryl-polyhydro-
alkyl-polyalkyl ester (generic).
721.11714 Alkenoic acid, reaction products with alkylamine-
alkanediyl diacrylate polymer and [oxybis(alkylene)]bis[alkyl-
alkanediol] salt (generic).
721.11715 Nonane, branched.

Sec.  721.11687   Fatty acids, tall-oil polymers with aminoalkyl, 
dialkyl alkane diamine, polyalkylene polyamine alkanepolyamine 
fraction, and tris-[(alkylamino) alkyl] phenol (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as fatty 
acids, tall-oil polymers with aminoalkyl, dialkyl alkane diamine, 
polyalkylene polyamine alkanepolyamine fraction, and tris-[(alkylamino) 
alkyl] phenol (PMN P-18-143) is subject to reporting under this section 
for the significant new uses described in paragraph (a)(2) of this 
section. The requirements of this section do not apply to quantities of 
the substance after they have been completely reacted (cured).
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o).
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N=1.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), (i), and (k) are applicable to manufacturers, 
importers, and processors of this substance.

[[Page 37796]]

    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11688   Isocyanic acid, polyalkylenepolycycloalkylene ester, 
2-alkoxy alkanol and 1-alkoxy alkanol and alkylene diol blocked 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
isocyanic acid, polyalkylenepolycycloalkylene ester, 2-alkoxy alkanol 
and 1-alkoxy alkanol and alkylene diol blocked (PMN P-18-154) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(3), and (c). When determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(a)(1), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1), (g)(3), and (g)(5). For purposes of 
Sec.  721.72(g)(1), this substance may cause: skin sensitization; 
respiratory sensitization; germ cell mutagenicity. For purposes of 
Sec.  721.72(g)(3), this substance may be: toxic to aquatic life. 
Alternative hazard and warning statements that meet the criteria of the 
Globally Harmonized System and OSHA Hazard Communication Standard may 
be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o). It is a significant new use to 
manufacture, process, or use the substance in any manner that results 
in inhalation exposure.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N=1.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11689  1,4-Cyclohexanedicarboxylic acid, 1,4-bis(2-
ethylhexyl) ester.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 1,4-
cyclohexanedicarboxylic acid, 1,4-bis(2-ethylhexyl) ester (PMN P-18-
273; CAS No. 84731-70-4) is subject to reporting under this section for 
the significant new uses described in paragraph (a)(2) of this section. 
The requirements of this section do not apply to quantities of the 
substance after they have been completely reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(3), (b), and (c). When determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(a)(1), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible. For purposes of 
Sec.  721.63(b), the concentration is set at 1.0%.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), (g)(1), and (g)(5). For purposes of Sec.  
721.72(e), the concentration is set at 1.0%. For purposes of Sec.  
721.72(g)(1), this substance may cause: specific target organ toxicity. 
Alternative hazard and warning statements that meet the criteria of the 
Globally Harmonized System and OSHA Hazard Communication Standard may 
be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f) and (k).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

Sec.  721.11690   Carbomonocylic-oxazolidine (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
carbomonocylic-oxazolidine (PMN P-18-290) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(3) through (5), (a)(6)(v) and (vi), (b), and (c). 
When determining which persons are reasonably likely to be exposed as 
required for Sec.  721.63(a)(1) and (a)(4), engineering control 
measures (e.g., enclosure or confinement of the operation, general and 
local ventilation) or administrative control measures (e.g., workplace 
policies and procedures) shall be considered and implemented to prevent 
exposure, where feasible. For purposes of Sec.  721.63(a)(5), 
respirators must provide a National Institute for Occupational Safety 
and Health (NIOSH) assigned protection factor (APF) of at least 10. For 
purposes of Sec.  721.63(b), the concentration is set at 1.0%.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), (g)(1), (g)(3), and (g)(5). For purposes of 
Sec.  721.72(e), the concentration is set at 1.0%. For purposes of 
Sec.  721.72(g)(1), this substance may cause: eye irritation; specific 
target organ toxicity. For purposes of Sec.  721.72(g)(3), this 
substance may be: toxic to aquatic life. Alternative hazard and warning 
statements that meet the criteria of the Globally Harmonized System and 
OSHA Hazard Communication Standard may be used.
    (iii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N=285.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (h), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11691   Propoxylated, ethoxylated alkoxyalkyl ether 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
propoxylated, ethoxylated alkoxyalkyl ether (PMN P-19-73) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section. The requirements of this section do 
not

[[Page 37797]]

apply to quantities of the substance after they have been completely 
reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(3) through (6), and (c). When determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1) and (a)(4), engineering control measures (e.g., enclosure 
or confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible. For purposes of Sec.  721.63(a)(5), respirators must 
provide a National Institute for Occupational Safety and Health (NIOSH) 
assigned protection factor (APF) of at least 1,000. For purposes of 
Sec.  721.63(a)(6), the airborne form(s) of the substance include: 
particulate (including solids or liquid droplets).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1), (g)(3), and (g)(5). For purposes of 
Sec.  721.72(g)(1), this substance may cause: skin irritation; serious 
eye damage; specific target organ toxicity. For purposes of Sec.  
721.72(g)(3), this substance may be: toxic to aquatic life. Alternative 
hazard and warning statements that meet the criteria of the Globally 
Harmonized System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. It is a 
significant new use to process the substance for use in a consumer 
product where the concentration of the substance is 1% or greater in 
the consumer product formulation.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N=24.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11692   Phosphoric acid, polymer with (hydroxyalkyl)-
alkanediol and alkanediol (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
phosphoric acid, polymer with (hydroxyalkyl)-alkanediol and alkanediol 
(PMN P-19-98) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section. The 
requirements of this section do not apply to quantities of the 
substance after they have been completely reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(3) through (6), (b), and (c). When determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1) and (a)(4), engineering control measures (e.g., enclosure 
or confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible. For purposes of Sec.  721.63(a)(5), respirators must 
provide a National Institute for Occupational Safety and Health (NIOSH) 
assigned protection factor (APF) of at least 50. For purposes of Sec.  
721.63(b), the concentration is set at 1.0%. For purposes of Sec.  
721.63(a)(6), the airborne form(s) of the substance include: 
particulate (including solids or liquid droplets).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), (g)(1), and (g)(5). For purposes of Sec.  
721.72(e), the concentration is set at 1.0%. For purposes of Sec.  
721.72(g)(1), this substance may cause: skin corrosion; severe eye 
damage; reproductive toxicity; specific target organ toxicity. 
Alternative hazard and warning statements that meet the criteria of the 
Globally Harmonized System and OSHA Hazard Communication Standard may 
be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o). It is a significant new use to use the 
substance other than as a flame retardant additive for intumescent 
coatings.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N=500.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11693   2-Propenoic acid, 2-(hydrogenated animal-based 
nitrogen-substituted)ethyl ester.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 2-
propenoic acid, 2-(hydrogenated animal-based nitrogen-substituted)ethyl 
ester (PMN P-19-122) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section. The 
requirements of this section do not apply to quantities of the 
substance after they have been completely reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(3) through (6), and (c). When determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1) and (a)(4), engineering control measures (e.g., enclosure 
or confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible. For purposes of Sec.  721.63(a)(5), respirators must 
provide a National Institute for Occupational Safety and Health (NIOSH) 
assigned protection factor (APF) of at least 50. For purposes of Sec.  
721.63(a)(6), the airborne form(s) of the substance include: 
particulate (including solids or liquid droplets).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1), (g)(3), and (g)(5). For purposes of 
Sec.  721.72(g)(1), this substance may cause: skin corrosion; serious 
eye damage; skin sensitization; reproductive toxicity; specific target 
organ toxicity. For purposes of Sec.  721.72(g)(3), this substance may 
be: toxic to aquatic life. Alternative hazard and warning statements 
that meet the criteria of the Globally Harmonized System and OSHA 
Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f). It is a significant new use to use the 
substance in consumer applications.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N=1.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i), and (k) are applicable to manufacturers, 
importers, and processors of this substance.

[[Page 37798]]

    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11694   2-Propenoic acid, nitrogen-substituted alkyl, N-C16-
18-acyl derivs. (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 2-
propenoic acid, nitrogen-substituted alkyl, N-C16-18-acyl derivs. (PMN 
P-20-83) is subject to reporting under this section for the significant 
new uses described in paragraph (a)(2) of this section. The 
requirements of this section do not apply to quantities of the 
substance after they have been completely reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(3) through (6), and (c). When determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1) and (a)(4), engineering control measures (e.g., enclosure 
or confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible. For purposes of Sec.  721.63(a)(5), respirators must 
provide a National Institute for Occupational Safety and Health (NIOSH) 
assigned protection factor (APF) of at least 50. For purposes of Sec.  
721.63(a)(6), the airborne form(s) of the substance include: 
particulate (including solids or liquid droplets).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1), (g)(3), and (g)(5). For purposes of 
Sec.  721.72(g)(1), this substance may cause: skin corrosion, serious 
eye damage, skin sensitization, reproductive toxicity, and specific 
target organ toxicity. For purposes of Sec.  721.72(g)(3), this 
substance may be: toxic to aquatic life. Alternative hazard and warning 
statements that meet the criteria of the Globally Harmonized System and 
OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f). It is a significant new use to use the 
substance in consumer applications.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N=1.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11695   Modified graphene (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
modified graphene (PMN P-20-5) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section. The requirements of this section do not apply to 
quantities of the substance after they have been completely reacted 
(cured), embedded into a thermoset polymer resin as an intermediate 
step before curing, or embedded into a permanent solid polymer form 
that is not intended to undergo further processing, except mechanical 
processing or physical blending.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(3) through (6), and (c). When determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1) and (a)(4), engineering control measures (e.g., enclosure 
or confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible. Where workers are reasonably expected to be exposed by 
inhalation to dust from the substance, dust controls shall be 
implemented that demonstrate an exposure reduction of at least 90%. For 
purposes of Sec.  721.63(a)(5), respirators must provide a National 
Institute for Occupational Safety and Health (NIOSH) assigned 
protection factor (APF) of at least 50. For purposes of Sec.  
721.63(a)(6), the airborne form(s) of the substance include: 
particulate (including solids or liquid droplets).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f) and (k). It is a significant new use to 
use the substance in an application method that results in inhalation 
exposure to workers.
    (iii) Disposal. Requirements as specified in Sec.  721.85(a)(1), 
(a)(2), (b)(1), (b)(2), (c)(1), and (c)(2). It is a significant new use 
to release the substance directly to air.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (e) and (i) through (k) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(ii) of 
this section.

Sec.  721.11696   Polysaccharide, polymer with unsaturated carboxylic 
acid and methacryloxyethyltrimethyl ammonium chloride, sodium salt, 
acid salt initiated (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
polysaccharide, polymer with unsaturated carboxylic acid and 
methacryloxyethyltrimethyl ammonium chloride, sodium salt, acid salt 
initiated (PMN P-20-58) is subject to reporting under this section for 
the significant new uses described in paragraph (a)(2) of this section. 
The requirements of this section do not apply to quantities of the 
substance after they have been completely reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(3), (b), and (c). When determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(a)(1), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible. For purposes of 
Sec.  721.63(b), the concentration is set at 1.0%.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), (g)(1), (g)(3), and (g)(5). For purposes of 
Sec.  721.72(e), the concentration is set at 1.0%. For purposes of 
Sec.  721.72(g)(1), this substance may cause: specific target organ 
toxicity. For the purposes of Sec.  721.72(g)(3), this substance may 
be: toxic to aquatic life. Alternative hazard and warning statements 
that meet the criteria of the Globally Harmonized

[[Page 37799]]

System and OSHA Hazard Communication Standard may be used.
    (iii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N=102.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (h), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11697   Ashes (residues), reactions products with 
dicarboxylic acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-
(trialkoxysilyl)alkoxy]methyl]oxirane (generic) (P-20-112).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as ashes 
(residues), reactions products with dicarboxylic acid, silicic acid 
(H4SiO4) tetra-Et ester and 2-[[3-(trialkoxysilyl)alkoxy]methyl]oxirane 
(PMN P-20-112) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section. The 
requirements of this section do not apply to quantities of the 
substance after they have been completely incorporated into a polymer 
matrix.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(4) through (6), (b), and (c). When determining which persons 
are reasonably likely to be exposed as required for Sec.  721.63(a)(4), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible. For purposes of 
Sec.  721.63(a)(5), respirators must provide a National Institute for 
Occupational Safety and Health (NIOSH) assigned protection factor (APF) 
of at least 50. For purposes of Sec.  721.63(a)(6), the airborne 
form(s) of the substance include: particulate (including solids or 
liquid droplets). For purposes of Sec.  721.63(b), the concentration is 
set at 0.1%.
    (A) As an alternative to the respirator requirements in paragraph 
(a)(2)(i) of this section, a manufacturer or processor may choose to 
follow the new chemical exposure limit (NCEL) provision listed in the 
TSCA Order for this substance. The NCEL is 0.05 mg/m\3\ as an 8-hour 
time weighted average. Persons who wish to pursue NCELs as an 
alternative to Sec.  721.63 respirator requirements may request to do 
so under Sec.  721.30. Persons whose Sec.  721.30 requests to use the 
NCEL approach are approved by EPA will be required to follow NCEL 
provisions comparable to those contained in the corresponding TSCA 
Order.
    (B) [Reserved]
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), (g)(1)(ii) through (ix), (g)(2) and (g)(5). For 
purposes of Sec.  721.72(e), the concentration is set at 0.1%. For 
purposes of Sec.  721.72(g)(2), avoid skin contact; avoid breathing 
substance; avoid ingestion; use respiratory protection or maintain 
workplace airborne concentrations at or below an 8-hour time-weighted 
average of 0.05 mg/m\3\; use skin protection. Alternative hazard and 
warning statements that meet the criteria of the Globally Harmonized 
System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k). It is a significant new use to 
manufacture the substances without sampling and analyzing the immediate 
precursor used to manufacture the substances according to the terms 
specified in the TSCA Order for the following elements: arsenic, 
barium, beryllium, cadmium, chromium, cobalt, copper, lead, manganese, 
mercury, nickel, selenium, silver, vanadium, and zinc. It is a 
significant new use to manufacture the substances at facilities other 
than those equipped with pollution controls, such as a bag house, that 
remove particulates from the air at 99% or greater efficiency. It is a 
significant new use to process the substances other than in an enclosed 
system that does not allow for the release of particulates or at 
facilities equipped with pollution controls, such as a bag house, that 
remove particulates from the air at 99% or greater efficiency.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (d) and (f) through (i) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

Sec.  721.11698   Ashes (residues), reactions products with substituted 
tricarboxylic acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-
(trialkoxysilyl)alkoxy]methyl] oxirane (generic) (P-20-113).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as ashes 
(residues), reactions products with substituted tricarboxylic acid, 
silicic acid (H4SiO4) tetra-Et ester and 2-[[3-
(trialkoxysilyl)alkoxy]methyl] oxirane (generic) (PMN P-20-113) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section. The requirements of this 
section do not apply to quantities of the substance after they have 
been completely incorporated into a polymer matrix.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(4) through (6), (b), and (c). When determining which persons 
are reasonably likely to be exposed as required for Sec.  721.63(a)(4), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible. For purposes of 
Sec.  721.63(a)(5), respirators must provide a National Institute for 
Occupational Safety and Health (NIOSH) assigned protection factor (APF) 
of at least 50. For purposes of Sec.  721.63(a)(6), the airborne 
form(s) of the substance include: particulate (including solids or 
liquid droplets). For purposes of Sec.  721.63(b), the concentration is 
set at 0.1%.
    (A) As an alternative to the respirator requirements in paragraph 
(a)(2)(i) of this section, a manufacturer or processor may choose to 
follow the new chemical exposure limit (NCEL) provision listed in the 
TSCA Order for this substance. The NCEL is 0.05 mg/m\3\ as an 8-hour 
time weighted average. Persons who wish to pursue NCELs as an 
alternative to Sec.  721.63 respirator requirements may request to do 
so under Sec.  721.30. Persons whose Sec.  721.30 requests to use the 
NCEL approach are approved by EPA will be required to follow NCEL 
provisions comparable to those contained in the corresponding TSCA 
Order.
    (B) [Reserved]
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), (g)(1)(ii) through (ix), (g)(2) and (g)(5). For 
purposes of Sec.  721.72(e),

[[Page 37800]]

the concentration is set at 0.1%. For purposes of Sec.  721.72(g)(2), 
avoid skin contact; avoid breathing substance; avoid ingestion; use 
respiratory protection or maintain workplace airborne concentrations at 
or below an 8-hour time-weighted average of 0.05 mg/m\3\; use skin 
protection. Alternative hazard and warning statements that meet the 
criteria of the Globally Harmonized System and OSHA Hazard 
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k). It is a significant new use to 
manufacture the substances without sampling and analyzing the immediate 
precursor used to manufacture the substances according to the terms 
specified in the TSCA Order for the following elements: arsenic, 
barium, beryllium, cadmium, chromium, cobalt, copper, lead, manganese, 
mercury, nickel, selenium, silver, vanadium, and zinc. It is a 
significant new use to manufacture the substances at facilities other 
than those equipped with pollution controls, such as a bag house, that 
remove particulates from the air at 99% or greater efficiency. It is a 
significant new use to process the substances other than in an enclosed 
system that does not allow for the release of particulates or at 
facilities equipped with pollution controls, such as a bag house, that 
remove particulates from the air at 99% or greater efficiency.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (d) and (f) through (i) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

Sec.  721.11699   Ashes (residues), reactions products with 
dicarboxylic acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-
(trialkoxysilyl)alkoxy]methyl]oxirane (generic) (P-20-114).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as ashes 
(residues), reactions products with dicarboxylic acid, silicic acid 
(H4SiO4) tetra-Et ester and 2-[[3-(trialkoxysilyl)alkoxy]methyl]oxirane 
(generic) (PMN P-20-114) is subject to reporting under this section for 
the significant new uses described in paragraph (a)(2) of this section. 
The requirements of this section do not apply to quantities of the 
substance after they have been completely incorporated into a polymer 
matrix.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63 (a)(4) through (6), (b), and (c). When determining which persons 
are reasonably likely to be exposed as required for Sec.  721.63(a)(1) 
and (a)(4), engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible. For purposes of Sec.  721.63(a)(5), respirators must 
provide a National Institute for Occupational Safety and Health (NIOSH) 
assigned protection factor (APF) of at least 50. For purposes of Sec.  
721.63(a)(6), the airborne form(s) of the substance include: 
particulate (including solids or liquid droplets). For purposes of 
Sec.  721.63(b), the concentration is set at 0.1%.
    (A) As an alternative to the respirator requirements in paragraph 
(a)(2)(i) of this section, a manufacturer or processor may choose to 
follow the new chemical exposure limit (NCEL) provision listed in the 
TSCA Order for this substance. The NCEL is 0.05 mg/m\3\ as an 8-hour 
time weighted average. Persons who wish to pursue NCELs as an 
alternative to Sec.  721.63 respirator requirements may request to do 
so under Sec.  721.30. Persons whose Sec.  721.30 requests to use the 
NCEL approach are approved by EPA will be required to follow NCEL 
provisions comparable to those contained in the corresponding TSCA 
Order.
    (B) [Reserved]
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), (g)(1)(ii) through (ix), (g)(2) and (g)(5). For 
purposes of Sec.  721.72(e), the concentration is set at 0.1%. For 
purposes of Sec.  721.72(g)(2), avoid skin contact; avoid breathing 
substance; avoid ingestion; use respiratory protection or maintain 
workplace airborne concentrations at or below an 8-hour time-weighted 
average of 0.05 mg/m\3\; use skin protection. Alternative hazard and 
warning statements that meet the criteria of the Globally Harmonized 
System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k). It is a significant new use to 
manufacture the substances without sampling and analyzing the immediate 
precursor used to manufacture the substances according to the terms 
specified in the TSCA Order for the following elements: arsenic, 
barium, beryllium, cadmium, chromium, cobalt, copper, lead, manganese, 
mercury, nickel, selenium, silver, vanadium, and zinc. It is a 
significant new use to manufacture the substances at facilities other 
than those equipped with pollution controls, such as a bag house, that 
remove particulates from the air at 99% or greater efficiency. It is a 
significant new use to process the substances other than in an enclosed 
system that does not allow for the release of particulates or at 
facilities equipped with pollution controls, such as a bag house, that 
remove particulates from the air at 99% or greater efficiency.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (d) and (f) through (i) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

Sec.  721.11700   Ashes (residues), reactions products with substituted 
tricarboxylic acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-
(trialkoxysilyl)alkoxy]methyl] oxirane (generic) (P-20-115).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as ashes 
(residues), reactions products with substituted tricarboxylic acid, 
silicic acid (H4SiO4) tetra-Et ester and 2-[[3-
(trialkoxysilyl)alkoxy]methyl] oxirane (generic) (PMN P-20-115) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section. The requirements of this 
section do not apply to quantities of the substance after they have 
been completely incorporated into a polymer matrix.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(4) through (6), (b), and (c). When determining which persons 
are reasonably likely to be exposed as required for Sec.  721.63(a)(4), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general

[[Page 37801]]

and local ventilation) or administrative control measures (e.g., 
workplace policies and procedures) shall be considered and implemented 
to prevent exposure, where feasible. For purposes of Sec.  
721.63(a)(5), respirators must provide a National Institute for 
Occupational Safety and Health (NIOSH) assigned protection factor (APF) 
of at least 50. For purposes of Sec.  721.63(a)(6), the airborne 
form(s) of the substance include: particulate (including solids or 
liquid droplets). For purposes of Sec.  721.63(b), the concentration is 
set at 0.1%.
    (A) As an alternative to the respirator requirements in paragraph 
(a)(2)(i) of this section, a manufacturer or processor may choose to 
follow the new chemical exposure limit (NCEL) provision listed in the 
TSCA Order for this substance. The NCEL is 0.05 mg/m\3\ as an 8-hour 
time weighted average. Persons who wish to pursue NCELs as an 
alternative to Sec.  721.63 respirator requirements may request to do 
so under Sec.  721.30. Persons whose Sec.  721.30 requests to use the 
NCEL approach are approved by EPA will be required to follow NCEL 
provisions comparable to those contained in the corresponding TSCA 
Order.
    (B) [Reserved]
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), (g)(1)(ii) through (ix), (g)(2) and (g)(5). For 
purposes of Sec.  721.72(e), the concentration is set at 0.1%. For 
purposes of Sec.  721.72(g)(2), avoid skin contact; avoid breathing 
substance; avoid ingestion; use respiratory protection or maintain 
workplace airborne concentrations at or below an 8-hour time-weighted 
average of 0.05 mg/m\3\; use skin protection. Alternative hazard and 
warning statements that meet the criteria of the Globally Harmonized 
System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k). It is a significant new use to 
manufacture the substances without sampling and analyzing the immediate 
precursor used to manufacture the substances according to the terms 
specified in the TSCA Order for the following elements: arsenic, 
barium, beryllium, cadmium, chromium, cobalt, copper, lead, manganese, 
mercury, nickel, selenium, silver, vanadium, and zinc. It is a 
significant new use to manufacture the substances at facilities other 
than those equipped with pollution controls, such as a bag house, that 
remove particulates from the air at 99% or greater efficiency. It is a 
significant new use to process the substances other than in an enclosed 
system that does not allow for the release of particulates or at 
facilities equipped with pollution controls, such as a bag house, that 
remove particulates from the air at 99% or greater efficiency.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (d) and (f) through (i) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

Sec.  721.11701   Ashes (residues), reactions products with 
dicarboxylic acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-
(trialkoxysilyl)alkoxy]methyl]oxirane (generic) (P-20-116).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as ashes 
(residues), reactions products with dicarboxylic acid, silicic acid 
(H4SiO4) tetra-Et ester and 2-[[3-(trialkoxysilyl)alkoxy]methyl]oxirane 
(generic) (PMN P-20-116) is subject to reporting under this section for 
the significant new uses described in paragraph (a)(2) of this section. 
The requirements of this section do not apply to quantities of the 
substance after they have been completely incorporated into a polymer 
matrix.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(4) through (6), (b), and (c). When determining which persons 
are reasonably likely to be exposed as required for Sec.  721.63(a)(4), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible. For purposes of 
Sec.  721.63(a)(5), respirators must provide a National Institute for 
Occupational Safety and Health (NIOSH) assigned protection factor (APF) 
of at least 50. For purposes of Sec.  721.63(a)(6), the airborne 
form(s) of the substance include. For purposes of Sec.  721.63(b), the 
concentration is set at 0.1%.
    (A) As an alternative to the respirator requirements in paragraph 
(a)(2)(i) of this section, a manufacturer or processor may choose to 
follow the new chemical exposure limit (NCEL) provision listed in the 
TSCA Order for this substance. The NCEL is 0.05 mg/m\3\ as an 8-hour 
time weighted average. Persons who wish to pursue NCELs as an 
alternative to Sec.  721.63 respirator requirements may request to do 
so under Sec.  721.30. Persons whose Sec.  721.30 requests to use the 
NCEL approach are approved by EPA will be required to follow NCEL 
provisions comparable to those contained in the corresponding TSCA 
Order.
    (B) [Reserved]
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), (g)(1)(ii) through (ix), (g)(2) and (g)(5). For 
purposes of Sec.  721.72(e), the concentration is set at 0.1%. For 
purposes of Sec.  721.72(g)(2), avoid skin contact; avoid breathing 
substance; avoid ingestion; use respiratory protection or maintain 
workplace airborne concentrations at or below an 8-hour time-weighted 
average of 0.05 mg/m\3\; use skin protection. Alternative hazard and 
warning statements that meet the criteria of the Globally Harmonized 
System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k). It is a significant new use to 
manufacture the substances without sampling and analyzing the immediate 
precursor used to manufacture the substances according to the terms 
specified in the TSCA Order for the following elements: arsenic, 
barium, beryllium, cadmium, chromium, cobalt, copper, lead, manganese, 
mercury, nickel, selenium, silver, vanadium, and zinc. It is a 
significant new use to manufacture the substances at facilities other 
than those equipped with pollution controls, such as a bag house, that 
remove particulates from the air at 99% or greater efficiency. It is a 
significant new use to process the substances other than in an enclosed 
system that does not allow for the release of particulates or at 
facilities equipped with pollution controls, such as a bag house, that 
remove particulates from the air at 99% or greater efficiency.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (d) and (f) through (i) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The

[[Page 37802]]

provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

Sec.  721.11702   Ashes (residues), reactions products with 
dicarboxylic acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-
(trialkoxysilyl)alkoxy]methyl]oxirane (generic) (P-20-117).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as ashes 
(residues), reactions products with dicarboxylic acid, silicic acid 
(H4SiO4) tetra-Et ester and 2-[[3-(trialkoxysilyl)alkoxy]methyl]oxirane 
(generic) (generic) (PMN P-20-117) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section. The requirements of this section do not apply to 
quantities of the substance after they have been completely 
incorporated into a polymer matrix.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(4) through (6), (b), and (c). When determining which persons 
are reasonably likely to be exposed as required for Sec.  721.63(a)(4), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible. For purposes of 
Sec.  721.63(a)(5), respirators must provide a National Institute for 
Occupational Safety and Health (NIOSH) assigned protection factor (APF) 
of at least 50. For purposes of Sec.  721.63(a)(6), the airborne 
form(s) of the substance include: particulate (including solids or 
liquid droplets). For purposes of Sec.  721.63(b), the concentration is 
set at 0.1%.
    (A) As an alternative to the respirator requirements in paragraph 
(a)(2)(i) of this section, a manufacturer or processor may choose to 
follow the new chemical exposure limit (NCEL) provision listed in the 
TSCA Order for this substance. The NCEL is 0.05 mg/m\3\ as an 8-hour 
time weighted average. Persons who wish to pursue NCELs as an 
alternative to Sec.  721.63 respirator requirements may request to do 
so under Sec.  721.30. Persons whose Sec.  721.30 requests to use the 
NCEL approach are approved by EPA will be required to follow NCEL 
provisions comparable to those contained in the corresponding TSCA 
Order.
    (B) [Reserved]
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), (g)(1)(ii) through (ix), (g)(2) and (g)(5). For 
purposes of Sec.  721.72(e), the concentration is set at 0.1%. For 
purposes of Sec.  721.72(g)(2), avoid skin contact; avoid breathing 
substance; avoid ingestion; use respiratory protection or maintain 
workplace airborne concentrations at or below an 8-hour time-weighted 
average of 0.05 mg/m\3\; use skin protection. Alternative hazard and 
warning statements that meet the criteria of the Globally Harmonized 
System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k). It is a significant new use to 
manufacture the substances without sampling and analyzing the immediate 
precursor used to manufacture the substances according to the terms 
specified in the TSCA Order for the following elements: arsenic, 
barium, beryllium, cadmium, chromium, cobalt, copper, lead, manganese, 
mercury, nickel, selenium, silver, vanadium, and zinc. It is a 
significant new use to manufacture the substances at facilities other 
than those equipped with pollution controls, such as a bag house, that 
remove particulates from the air at 99% or greater efficiency. It is a 
significant new use to process the substances other than in an enclosed 
system that does not allow for the release of particulates or at 
facilities equipped with pollution controls, such as a bag house, that 
remove particulates from the air at 99% or greater efficiency.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (d) and (f) through (i) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

Sec.  721.11703   Silsesquioxanes, alkyl, alkoxy- and hydroxy- 
terminated (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
silsesquioxanes, alkyl, alkoxy- and hydroxy- terminated (PMN P-20-173) 
is subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section. The requirements of this 
section do not apply to quantities of the substance after they have 
been completely reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(3) through (6), (b), and (c). When determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1) and (a)(4), engineering control measures (e.g., enclosure 
or confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible. For purposes of Sec.  721.63(a)(5), respirators must 
provide a National Institute for Occupational Safety and Health (NIOSH) 
assigned protection factor (APF) of at least 10. For purposes of Sec.  
721.63(b), the concentration is set at 1.0%. For purposes of Sec.  
721.63(a)(6), the airborne form(s) of the substance include: 
particulate (including solids or liquid droplets).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), (g)(1), (g)(3), and (g)(5). For purposes of 
Sec.  721.72(e), the concentration is set at 1.0%. For purposes of 
Sec.  721.72(g)(1), this substance may cause: skin irritation; eye 
irritation; serious eye damage; specific target organ toxicity. For 
purposes of Sec.  721.72(g)(3), this substance may cause: aquatic 
toxicity. Alternative hazard and warning statements that meet the 
criteria of the Globally Harmonized System and OSHA Hazard 
Communication Standard may be used.
    (iii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N=1.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (h), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

[[Page 37803]]

Sec.  721.11704   1,3-Benzenedicarboxylic acid, polymer with 2,2-
dimethyl-1,3-propanediol, 1,2-ethanediol, 2-ethyl-2- (hydroxymethyl)- 
1,3-propanediol, hexanedioic acid, 1,6-hexanediol and 1,3-
isobenzofurandione, N-[[1,3,3-trimethyl-5-[[[2-[(1-oxo-2- propen-1-
yl)oxy]ethoxy]carbonyl]amino]cyclohexyl]methyl]carbamate N-[3,3,5-
trimethyl-5-[[[[2-[(1-oxo-2-propen-1- 
yl)oxy]ethoxy]carbonyl]amino]methyl]cyclohexyl]carbamate.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 1,3-
benzenedicarboxylic acid, polymer with 2,2-dimethyl-1,3-propanediol, 
1,2-ethanediol, 2-ethyl-2- (hydroxymethyl)-1,3-propanediol, hexanedioic 
acid, 1,6-hexanediol and 1,3-isobenzofurandione, N-[[1,3,3-trimethyl-5-
[[[2-[(1-oxo-2- propen-1-
yl)oxy]ethoxy]carbonyl]amino]cyclohexyl]methyl]carbamate N-[3,3,5-
trimethyl-5-[[[[2-[(1-oxo-2-propen-1-
yl)oxy]ethoxy]carbonyl]amino]methyl]cyclohexyl]carbamate (PMN P-21-10; 
CAS No. 2460376-09-2) is subject to reporting under this section for 
the significant new uses described in paragraph (a)(2) of this section. 
The requirements of this section do not apply to quantities of the 
substance after they have been completely reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(3), and (c). When determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(a)(1), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1), and (g)(5). For purposes of Sec.  
721.72(g)(1), this substance may cause: skin irritation, eye 
irritation, skin sensitization, and respiratory sensitization. 
Alternative hazard and warning statements that meet the criteria of the 
Globally Harmonized System and OSHA Hazard Communication Standard may 
be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o). It is a significant new use to 
manufacture, process, or use the substance in any manner that results 
in inhalation exposure.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11705   Methyl phenylethyl cyclopropanemethanol (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as methyl 
phenylethyl cyclopropanemethanol (PMN P-21-13) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(3) through (5), (a)(6)(v) and (vi), and (c). When 
determining which persons are reasonably likely to be exposed as 
required for Sec.  721.63(a)(1) and (a)(4), engineering control 
measures (e.g., enclosure or confinement of the operation, general and 
local ventilation) or administrative control measures (e.g., workplace 
policies and procedures) shall be considered and implemented to prevent 
exposure, where feasible. For purposes of Sec.  721.63(a)(5), 
respirators must provide a National Institute for Occupational Safety 
and Health (NIOSH) assigned protection factor (APF) of at least 50.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1), (g)(3), and (g)(5). For purposes of 
Sec.  721.72(g)(1), this substance may cause: eye irritation; skin 
sensitization. For purposes of Sec.  721.72(g)(3), this substance may 
be: toxic to aquatic life. Alternative hazard and warning statements 
that meet the criteria of the Globally Harmonized System and OSHA 
Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. It is a 
significant new use to use the substance in consumer products unless 
the concentration of the substance is less than 1%.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N=1.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11706   [(Substituted-carbomonocyclic)amino] oxoalkenoic 
acid, inorganic salt (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
[(substituted-carbomonocyclic)amino] oxoalkenoic acid, inorganic salt 
(PMN P-21-17) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section. The 
requirements of this section do not apply to quantities of the 
substance after they have been completely reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(3) through (6), and (c). When determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1) and (a)(4), engineering control measures (e.g., enclosure 
or confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible. For purposes of Sec.  721.63(a)(5), respirators must 
provide a National Institute for Occupational Safety and Health (NIOSH) 
assigned protection factor (APF) of at least 50. For purposes of Sec.  
721.63(a)(6), the airborne form(s) of the substance include: 
particulate (including solids or liquid droplets).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f) (g)(1), and (g)(5). For purposes of Sec.  
721.72(g)(1), this substance may cause: skin sensitization; specific 
target organ toxicity. Alternative hazard and warning statements that 
meet the criteria of the Globally Harmonized System and OSHA Hazard 
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f). It is a significant new use to use the 
substance other than as an additive to improve physical properties in 
rubber products.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers, importers, and 
processors of this substance.

[[Page 37804]]

    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11707   Sulfonium, triphenyl-, heterocyclic compound-
carboxylate (1:1) (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
sulfonium, triphenyl-, heterocyclic compound-carboxylate (1:1) (PMN P-
21-18) is subject to reporting under this section for the significant 
new uses described in paragraph (a)(2) of this section. The 
requirements of this section do not apply to quantities of the 
substance after they have been completely reacted or adhered (during 
photolithographic processes) onto a semiconductor wafer surface or 
similar manufactured article used in the production of semiconductor 
technologies.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i) and (iii), (a)(3), and (c). When determining 
which persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1), engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii) and (v), 
(g)(3)(i) and (ii), and (g)(5). For purposes of Sec.  721.72(e), the 
concentration is set at 1%. For purposes of Sec.  721.72(g)(1), this 
substance may cause: skin irritation; acute toxicity; skin 
sensitization; serious eye damage; specific target organ toxicity; 
neurotoxicity; genetic toxicity; reproductive toxicity. Alternative 
hazard and warning statements that meet the criteria of the Globally 
Harmonized System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f), (k), and (t). It is a significant new 
use to import the substance other than in solution, unless in sealed 
containers weighing 5 kilograms or less. It is a significant new use to 
process the substance in any way that generates dust, mist, or aerosol 
in a non-enclosed process. It is a significant new use to manufacture 
the substance longer than 18 months.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

Sec.  721.11708   Sulfonium, carbocyclic-, salt with 1-(alkyl) 2-[4-
[polyhydro-2-carbomonocyclic-5-(polyfluoro-2-sulfoalkyl)-4,7-methano-
1,3-benzodioxol-2-yl]carbomonocyclic oxy]acetate (1:1) (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
sulfonium, carbocyclic-, salt with 1-(alkyl) 2-[4-[polyhydro-2-
carbomonocyclic-5-(polyfluoro-2-sulfoalkyl)-4,7-methano-1,3-
benzodioxol-2-yl]carbomonocyclic oxy]acetate (1:1) (PMN P-21-23) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section. The requirements of this 
section do not apply to quantities of the substance after they have 
been completely reacted or adhered onto a semiconductor wafer surface 
or similar manufactured article used in the production of semiconductor 
technologies.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i) and (iii), (a)(3), and (c). When determining 
which persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1), engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii) and (v), 
(g)(3)(i) and (ii), and (g)(5). For purposes of Sec.  721.72(e), the 
concentration is set at 1%. For purposes of Sec.  721.72(g)(1), this 
substance may cause: skin irritation; acute toxicity; skin 
sensitization; serious eye damage; specific target organ toxicity; 
neurotoxicity; genetic toxicity; reproductive toxicity. Alternative 
hazard and warning statements that meet the criteria of the Globally 
Harmonized System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f), (k), and (t). It is a significant new 
use to import the substance other than in solution, unless in sealed 
containers weighing 5 kilograms or less. It is a significant new use to 
process the substance in any way that generates dust, mist, or aerosol 
in a non-enclosed process. It is a significant new use to manufacture 
the substance longer than 18 months.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

Sec.  721.11709   Sulfonium, triphenyl-, polyfluoro-polyhydrospiro[9H-
carbopolycyclic-9,2'-[4,7]methano[1,3]benzodioxole]-5'-alkenesulfonic 
acid (1:1) (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
sulfonium, triphenyl-, polyfluoro-polyhydrospiro[9H-carbopolycyclic-
9,2'-[4,7]methano[1,3]benzodioxole]-5'-alkenesulfonic acid (1:1) (PMN 
P-21-64) is subject to reporting under this section for the significant 
new uses described in paragraph (a)(2) of this section. The 
requirements of this section do not apply to quantities of the 
substance after they have been completely reacted or adhered onto a 
semiconductor wafer surface or similar manufactured article used in the 
production of semiconductor technologies.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i) and (iii), (a)(3), and (c). When determining 
which persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1), engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible.

[[Page 37805]]

    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii) and (v), 
(g)(3)(i) and (ii), and (g)(5). For purposes of Sec.  721.72(e), the 
concentration is set at 1%. For purposes of Sec.  721.72(g)(1), this 
substance may cause: skin irritation; acute toxicity; skin 
sensitization; serious eye damage; specific target organ toxicity; 
neurotoxicity; genetic toxicity; reproductive toxicity. Alternative 
hazard and warning statements that meet the criteria of the Globally 
Harmonized System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f), (k), and (t). It is a significant new 
use to import the substance other than in solution, unless in sealed 
containers weighing 5 kilograms or less. It is a significant new use to 
process the substance in any way that generates dust, mist, or aerosol 
in a non-enclosed process. It is a significant new use to manufacture 
the substance longer than 18 months.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

Sec.  721.11710   Heteropolycyclic, trihaloalkyl carbomonocycle-, 
hydroxy carbomonocyclic salt (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
heteropolycyclic, trihaloalkyl carbomonocycle-, hydroxy carbomonocyclic 
salt (PMN P-21-27) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section. The 
requirements of this section do not apply to quantities of the 
substance after they have been completely reacted or adhered (during 
photolithographic processes) onto a semiconductor wafer surface or 
similar manufactured article used in the production of semiconductor 
technologies.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i) and (iii), (a)(3), and (c). When determining 
which persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1), engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii) and (v), 
(g)(3)(i) and (ii), and (g)(5). For purposes of Sec.  721.72(e), the 
concentration is set at 1%. For purposes of Sec.  721.72(g)(1), this 
substance may cause: skin irritation; acute toxicity; skin 
sensitization; serious eye damage; specific target organ toxicity; 
neurotoxicity; genetic toxicity; reproductive toxicity. Alternative 
hazard and warning statements that meet the criteria of the Globally 
Harmonized System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f), (k), and (t). It is a significant new 
use to import the substance other than in solution, unless in sealed 
containers weighing 5 kilograms or less. It is a significant new use to 
process the substance in any way that generates dust, mist, or aerosol 
in a non-enclosed process. It is a significant new use to manufacture 
the substance longer than 18 months.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

Sec.  721.11711   Sulfonium, tricarbocyclic-, 2-heteroatom-substituted-
4-(alkyl)carbomonocyclic carboxylate (1:1) (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
sulfonium, tricarbocyclic-,2-heteroatom-substituted-4-
(alkyl)carbomonocyclic carboxylate (1:1) (PMN P-21-42) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section. The requirements of this section do 
not apply to quantities of the substance after they have been 
completely reacted or adhered (during photolithographic processes) onto 
a semiconductor wafer surface or similar manufactured article used in 
the production of semiconductor technologies.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i) and (iii), (a)(3), and (c). When determining 
which persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1), engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii) and (v), 
(g)(3)(i) and (ii), and (g)(5). For purposes of Sec.  721.72(e), the 
concentration is set at 1%. For purposes of Sec.  721.72(g)(1), this 
substance may cause: skin irritation; acute toxicity; skin 
sensitization; serious eye damage; specific target organ toxicity; 
neurotoxicity; genetic toxicity; reproductive toxicity. Alternative 
hazard and warning statements that meet the criteria of the Globally 
Harmonized System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f), (k), and (t). It is a significant new 
use to import the substance other than in solution, unless in sealed 
containers weighing 5 kilograms or less. It is a significant new use to 
process the substance in any way that generates dust, mist, or aerosol 
in a non-enclosed process. It is a significant new use to manufacture 
the substance longer than 18 months.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

[[Page 37806]]

Sec.  721.11712   2-Propenoic acid, 2-methyl-, aminoalkyl ester, 
polymer with hydroxyalkyl alkenoate and octadecyl alkenoate, acetate 
(salts) (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 2-
propenoic acid, 2-methyl-, aminoalkyl ester, polymer with hydroxyalkyl 
alkenoate and octadecyl alkenoate, acetate (salts) (PMN P-21-54) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section. The requirements of this 
section do not apply to quantities of the substance after they have 
been incorporated into an article as defined at Sec.  720.3(c).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(3), (b), and (c). When determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(a)(1), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible. For purposes of 
Sec.  721.63(b), the concentration is set at 1.0%.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), (g)(1), (g)(3), and (g)(5). For purposes of 
Sec.  721.72(e), the concentration is set at 1.0%. For purposes of 
Sec.  721.72(g)(1), this substance may cause: skin irritation; eye 
irritation; and specific target organ toxicity. For purposes of Sec.  
721.72(g)(3), this substance may be: toxic to aquatic life. Alternative 
hazard and warning statements that meet the criteria of the Globally 
Harmonized System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. It is a 
significant new use to manufacture or process the substance in any 
manner that results in inhalation exposure. It is a significant new use 
to use the substance in an application method that results in 
inhalation exposure. It is a significant new use to use the substance 
in a product that is applied by a consumer.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N=52. Before totaling the 
releases of the substance to water from all operations at a site as 
described in 40 CFR 721.91(a)(5), you may subtract up to 90 percent for 
any releases that will be treated using primary and secondary 
wastewater treatment as defined in 40 CFR part 133.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11713   Heterocyclic-polycarboxylic acid, polyhaloaryl-
polyhydro-alkyl-polyalkyl ester (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
heterocyclic-polycarboxylic acid, polyhaloaryl-polyhydro-alkyl-
polyalkyl ester (PMN P-21-63) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(3), (b), and (c). When determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(a)(1), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible. For purposes of 
Sec.  721.63(b), the concentration is set at 1.0%.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), (g)(1), (g)(3), and (g)(5). For purposes of 
Sec.  721.72(e), the concentration is set at 1.0%. For purposes of 
Sec.  721.72(g)(1), this substance may cause: skin irritation; acute 
toxicity; reproductive toxicity; specific target organ toxicity. For 
purposes of Sec.  721.72(g)(3), this substance may be: toxic to aquatic 
life. Alternative hazard and warning statements that meet the criteria 
of the Globally Harmonized System and OSHA Hazard Communication 
Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o).
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11714   Alkenoic acid, reaction products with alkylamine-
alkanediyl diacrylate polymer and [oxybis(alkylene)]bis[alkyl-
alkanediol] salt (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
alkenoic acid, reaction products with alkylamine-alkanediyl diacrylate 
polymer and [oxybis(alkylene)]bis[alkyl-alkanediol] (PMN P-21-65) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section. The requirements of this 
section do not apply to quantities of the substance after they have 
been completely reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(3) through (6) and (c). When determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1) and (a)(4), engineering control measures (e.g., enclosure 
or confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible. For purposes of Sec.  721.63(a)(5), respirators must 
provide a National Institute for Occupational Safety and Health (NIOSH) 
assigned protection factor (APF) of at least 1,000. For purposes of 
Sec.  721.63(a)(6), the airborne form(s) of the substance include: 
particulate (including solids or liquid droplets).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1), and (g)(5). For purposes of Sec.  
721.72(g)(1), this substance may cause: skin irritation; eye 
irritation; specific target organ toxicity. Alternative hazard and 
warning statements that meet the criteria of the Globally Harmonized 
System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o). It is a significant new use to use the 
substance in a spray application.
    (b) Specific requirements. The provisions of subpart A of this part

[[Page 37807]]

apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11715   Nonane, branched.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as nonane, branched 
(PMN P-21-125; CAS No. 85408-10-2) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(3) through (5), (a)(6)(v) and (vi), (b), and (c). 
When determining which persons are reasonably likely to be exposed as 
required for Sec.  721.63(a)(1) and (a)(4), engineering control 
measures (e.g., enclosure or confinement of the operation, general and 
local ventilation) or administrative control measures (e.g., workplace 
policies and procedures) shall be considered and implemented to prevent 
exposure, where feasible. For purposes of Sec.  721.63(a)(5), 
respirators must provide a National Institute for Occupational Safety 
and Health (NIOSH) assigned protection factor (APF) of at least 50. For 
purposes of Sec.  721.63(b), the concentration is set at 1.0%.
    (A) As an alternative to the respirator requirements in paragraph 
(a)(2)(i) of this section, a manufacturer or processor may choose to 
follow the new chemical exposure limit (NCEL) provision listed in the 
TSCA Order for this substance. The NCEL is 0.72 mg/m\3\ as an 8-hour 
time weighted average. Persons who wish to pursue NCELs as an 
alternative to Sec.  721.63 respirator requirements may request to do 
so under Sec.  721.30. Persons whose Sec.  721.30 requests to use the 
NCELs approach are approved by EPA will be required to follow NCELs 
provisions comparable to those contained in the corresponding TSCA 
Order.
    (B) [Reserved]
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), (g)(1), (g)(3), and (g)(5). For purposes of 
Sec.  721.72(e), the concentration is set at 1.0%. For purposes of 
Sec.  721.72(g)(1), this substance may cause: skin irritation; eye 
irritation; reproductive toxicity; specific target organ toxicity; 
aspiration hazard. For purposes of Sec.  721.72(g)(3), this substance 
may be: toxic to aquatic life. Alternative hazard and warning 
statements that meet the criteria of the Globally Harmonized System and 
OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k).
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

[FR Doc. 2022-13360 Filed 6-23-22; 8:45 am]
BILLING CODE 6560-50-P