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• Is not subject to requirements of 

Section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (15 U.S.C. 272 note) because 

application of those requirements would 

be inconsistent with the Clean Air Act; 

and 

• Does not provide the EPA with the 

discretionary authority to address 

disproportionate human health or 

environmental effects with practical, 

appropriate, and legally permissible 

methods under Executive Order 12898 

(59 FR 7629, February 16, 1994). 

In addition, the SIP is not approved 

to apply on any Indian reservation land 

or in any other area where the EPA or 

an Indian tribe has demonstrated that a 

tribe has jurisdiction. In those areas of 

Indian country, the proposed rule does 

not have tribal implications and will not 

impose substantial direct costs on tribal 

governments or preempt tribal law as 

specified by Executive Order 13175 (65 

FR 67249, November 9, 2000). 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Incorporation by 

reference, Intergovernmental relations, 

Nitrogen dioxide, Ozone, Reporting and 

recordkeeping requirements, Volatile 

organic compounds. 

Authority: 42 U.S.C. 7401 et seq. 

Dated: June 14, 2022. 

Martha Guzman Aceves, 

Regional Administrator, Region IX. 

[FR Doc. 2022–13377 Filed 6–23–22; 8:45 am] 

BILLING CODE 6560–50–P 

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: wysong.william@epa.gov. 

For general information contact: The 

TSCA-Hotline, ABVI-Goodwill, 422 

South Clinton Ave., Rochester, NY 

14620; telephone number: (202) 554– 

1404; email address: TSCA-Hotline@

epa.gov. 

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 


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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 nonconfidential 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 anticorrosive 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. 


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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: Carbomonocylicoxazolidine (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 


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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 nitrogensubstituted)ethyl ester (generic) (P–19– 

122) and 2-propenoic acid, nitrogensubstituted 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 


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• 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. 


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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/m3

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-propen1- 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 


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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: [(Substitutedcarbomonocyclic)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 compoundcarboxylate (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; 


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• 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-methano1,3-benzodioxol-2-yl]carbomonocyclic 

oxy]acetate (1:1) (generic) (P–21–23) and 

sulfonium, triphenyl-, polyfluoropolyhydrospiro[9H-carbopolycyclic9,2′-[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 


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• 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-heteroatomsubstituted-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: Heterocyclicpolycarboxylic acid, polyhaloarylpolyhydro-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 


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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 alkylaminealkanediyl 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 


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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/tscainventory. 

VII. Development and Submission of 

Information 

EPA recognizes that TSCA section 5 

does not require developing any 

particular new information (e.g., 

generating test data) before submission 

of a SNUN. There is an exception: If a 

person is required to submit information 

for a chemical substance pursuant to a 

rule, 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-managingchemicals-under-tsca/alternative-testmethods-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 nonexempt 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 screeninglevel 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. 


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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-toxicsubstances-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/lawsregulations-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. 


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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 

■ 1. The authority citation for part 721 

continues to read as follows: 

Authority: 15 U.S.C. 2604, 2607, and 

2625(c). 

■ 2. Add §§ 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 nitrogensubstituted)ethyl ester. 

721.11694 2-Propenoic acid, nitrogensubstituted 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, alkoxyand 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 [(Substitutedcarbomonocyclic)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-benzodioxol2-yl]carbomonocyclic oxy]acetate (1:1) 

(generic). 

721.11709 Sulfonium, triphenyl-, 

polyfluoro-polyhydrospiro[9Hcarbopolycyclic-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-alkylpolyalkyl ester (generic). 

721.11714 Alkenoic acid, reaction products 

with alkylamine-alkanediyl diacrylate 

polymer and [oxybis(alkylene)]bis[alkylalkanediol] salt (generic). 

721.11715 Nonane, branched. 

§ 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 § 721.80(o). 

(ii) Release to water. Requirements as 

specified in § 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 

§ 721.125(a) through (c), (i), and (k) are 

applicable to manufacturers, importers, 

and processors of this substance. 


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(2) Limitation or revocation of certain 

notification requirements. The 

provisions of § 721.185 apply to this 

section. 

§ 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 

§ 721.63(a)(1), (a)(3), and (c). When 

determining which persons are 

reasonably likely to be exposed as 

required for § 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 § 721.72(a) 

through (d), (f), (g)(1), (g)(3), and (g)(5). 

For purposes of § 721.72(g)(1), this 

substance may cause: skin sensitization; 

respiratory sensitization; germ cell 

mutagenicity. For purposes of 

§ 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 § 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 § 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 

§ 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 § 721.185 apply to this 

section. 

§ 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 

§ 721.63(a)(1), (a)(3), (b), and (c). When 

determining which persons are 

reasonably likely to be exposed as 

required for § 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 § 721.63(b), the concentration is set at 

1.0%. 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (f), (g)(1), and (g)(5). For 

purposes of § 721.72(e), the 

concentration is set at 1.0%. For 

purposes of § 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 § 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 

§ 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 § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

(a)(2)(iii) of this section. 

§ 721.11690 Carbomonocylic-oxazolidine 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as carbomonocylicoxazolidine (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 

§ 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 § 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 § 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 

§ 721.63(b), the concentration is set at 

1.0%. 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (f), (g)(1), (g)(3), and (g)(5). For 

purposes of § 721.72(e), the 

concentration is set at 1.0%. For 

purposes of § 721.72(g)(1), this 

substance may cause: eye irritation; 

specific target organ toxicity. For 

purposes of § 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 § 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 

§ 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 § 721.185 apply to this 

section. 

§ 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 


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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 

§ 721.63(a)(1), (a)(3) through (6), and (c). 

When determining which persons are 

reasonably likely to be exposed as 

required for § 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 § 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 

§ 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 § 721.72(a) 

through (d), (f), (g)(1), (g)(3), and (g)(5). 

For purposes of § 721.72(g)(1), this 

substance may cause: skin irritation; 

serious eye damage; specific target organ 

toxicity. For purposes of § 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 § 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 

§ 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 § 721.185 apply to this 

section. 

§ 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 

§ 721.63(a)(1), (a)(3) through (6), (b), and 

(c). When determining which persons 

are reasonably likely to be exposed as 

required for § 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 § 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 

§ 721.63(b), the concentration is set at 

1.0%. For purposes of § 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 § 721.72(a) 

through (f), (g)(1), and (g)(5). For 

purposes of § 721.72(e), the 

concentration is set at 1.0%. For 

purposes of § 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 § 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 § 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 

§ 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 § 721.185 apply to this 

section. 

§ 721.11693 2-Propenoic acid, 2- 

(hydrogenated animal-based nitrogensubstituted)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 nitrogensubstituted)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 

§ 721.63(a)(1), (a)(3) through (6), and (c). 

When determining which persons are 

reasonably likely to be exposed as 

required for § 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 § 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 

§ 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 § 721.72(a) 

through (d), (f), (g)(1), (g)(3), and (g)(5). 

For purposes of § 721.72(g)(1), this 

substance may cause: skin corrosion; 

serious eye damage; skin sensitization; 

reproductive toxicity; specific target 

organ toxicity. For purposes of 

§ 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 § 721.80(f). It is a significant 

new use to use the substance in 

consumer applications. 

(iv) Release to water. Requirements as 

specified in § 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 

§ 721.125(a) through (i), and (k) are 

applicable to manufacturers, importers, 

and processors of this substance. 


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(2) Limitation or revocation of certain 

notification requirements. The 

provisions of § 721.185 apply to this 

section. 

§ 721.11694 2-Propenoic acid, nitrogensubstituted 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 

§ 721.63(a)(1), (a)(3) through (6), and (c). 

When determining which persons are 

reasonably likely to be exposed as 

required for § 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 § 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 

§ 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 § 721.72(a) 

through (d), (f), (g)(1), (g)(3), and (g)(5). 

For purposes of § 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 

§ 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 § 721.80(f). It is a significant 

new use to use the substance in 

consumer applications. 

(iv) Release to water. Requirements as 

specified in § 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 

§ 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 § 721.185 apply to this 

section. 

§ 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 

§ 721.63(a)(1), (a)(3) through (6), and (c). 

When determining which persons are 

reasonably likely to be exposed as 

required for § 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 § 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 

§ 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 § 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 § 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 § 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 

§ 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 § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

(a)(2)(ii) of this section. 

§ 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 

§ 721.63(a)(1), (a)(3), (b), and (c). When 

determining which persons are 

reasonably likely to be exposed as 

required for § 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 § 721.63(b), the concentration is set at 

1.0%. 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (f), (g)(1), (g)(3), and (g)(5). For 

purposes of § 721.72(e), the 

concentration is set at 1.0%. For 

purposes of § 721.72(g)(1), this 

substance may cause: specific target 

organ toxicity. For the purposes of 

§ 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 


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System and OSHA Hazard 

Communication Standard may be used. 

(iii) Release to water. Requirements as 

specified in § 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 

§ 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 § 721.185 apply to this 

section. 

§ 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 

§ 721.63(a)(4) through (6), (b), and (c). 

When determining which persons are 

reasonably likely to be exposed as 

required for § 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 § 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 

§ 721.63(a)(6), the airborne form(s) of 

the substance include: particulate 

(including solids or liquid droplets). For 

purposes of § 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/m3 as an 8-hour 

time weighted average. Persons who 

wish to pursue NCELs as an alternative 

to § 721.63 respirator requirements may 

request to do so under § 721.30. Persons 

whose § 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 § 721.72(a) 

through (f), (g)(1)(ii) through (ix), (g)(2) 

and (g)(5). For purposes of § 721.72(e), 

the concentration is set at 0.1%. For 

purposes of § 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/m3; 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 § 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 

§ 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 § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

(a)(2)(iii) of this section. 

§ 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 

§ 721.63(a)(4) through (6), (b), and (c). 

When determining which persons are 

reasonably likely to be exposed as 

required for § 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 § 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 

§ 721.63(a)(6), the airborne form(s) of 

the substance include: particulate 

(including solids or liquid droplets). For 

purposes of § 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/m3 as an 8-hour 

time weighted average. Persons who 

wish to pursue NCELs as an alternative 

to § 721.63 respirator requirements may 

request to do so under § 721.30. Persons 

whose § 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 § 721.72(a) 

through (f), (g)(1)(ii) through (ix), (g)(2) 

and (g)(5). For purposes of § 721.72(e), 


jspears on DSK121TN23PROD with PROPOSALS1
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the concentration is set at 0.1%. For 

purposes of § 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/m3; 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 § 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 

§ 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 § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

(a)(2)(iii) of this section. 

§ 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 § 721.63 

(a)(4) through (6), (b), and (c). When 

determining which persons are 

reasonably likely to be exposed as 

required for § 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 § 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 

§ 721.63(a)(6), the airborne form(s) of 

the substance include: particulate 

(including solids or liquid droplets). For 

purposes of § 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/m3 as an 8-hour 

time weighted average. Persons who 

wish to pursue NCELs as an alternative 

to § 721.63 respirator requirements may 

request to do so under § 721.30. Persons 

whose § 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 § 721.72(a) 

through (f), (g)(1)(ii) through (ix), (g)(2) 

and (g)(5). For purposes of § 721.72(e), 

the concentration is set at 0.1%. For 

purposes of § 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/m3; 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 § 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 

§ 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 § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

(a)(2)(iii) of this section. 

§ 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 

§ 721.63(a)(4) through (6), (b), and (c). 

When determining which persons are 

reasonably likely to be exposed as 

required for § 721.63(a)(4), engineering 

control measures (e.g., enclosure or 

confinement of the operation, general 


jspears on DSK121TN23PROD with PROPOSALS1
Federal Register / Vol. 87, No. 121 / Friday, June 24, 2022 / Proposed Rules 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 § 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 

§ 721.63(a)(6), the airborne form(s) of 

the substance include: particulate 

(including solids or liquid droplets). For 

purposes of § 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/m3 as an 8-hour 

time weighted average. Persons who 

wish to pursue NCELs as an alternative 

to § 721.63 respirator requirements may 

request to do so under § 721.30. Persons 

whose § 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 § 721.72(a) 

through (f), (g)(1)(ii) through (ix), (g)(2) 

and (g)(5). For purposes of § 721.72(e), 

the concentration is set at 0.1%. For 

purposes of § 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/m3; 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 § 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 

§ 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 § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

(a)(2)(iii) of this section. 

§ 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 

§ 721.63(a)(4) through (6), (b), and (c). 

When determining which persons are 

reasonably likely to be exposed as 

required for § 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 § 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 

§ 721.63(a)(6), the airborne form(s) of 

the substance include. For purposes of 

§ 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/m3 as an 8-hour 

time weighted average. Persons who 

wish to pursue NCELs as an alternative 

to § 721.63 respirator requirements may 

request to do so under § 721.30. Persons 

whose § 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 § 721.72(a) 

through (f), (g)(1)(ii) through (ix), (g)(2) 

and (g)(5). For purposes of § 721.72(e), 

the concentration is set at 0.1%. For 

purposes of § 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/m3; 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 § 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 

§ 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 


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provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

(a)(2)(iii) of this section. 

§ 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 

§ 721.63(a)(4) through (6), (b), and (c). 

When determining which persons are 

reasonably likely to be exposed as 

required for § 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 § 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 

§ 721.63(a)(6), the airborne form(s) of 

the substance include: particulate 

(including solids or liquid droplets). For 

purposes of § 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/m3 as an 8-hour 

time weighted average. Persons who 

wish to pursue NCELs as an alternative 

to § 721.63 respirator requirements may 

request to do so under § 721.30. Persons 

whose § 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 § 721.72(a) 

through (f), (g)(1)(ii) through (ix), (g)(2) 

and (g)(5). For purposes of § 721.72(e), 

the concentration is set at 0.1%. For 

purposes of § 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/m3; 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 § 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 

§ 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 § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

(a)(2)(iii) of this section. 

§ 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 

§ 721.63(a)(1), (a)(3) through (6), (b), and 

(c). When determining which persons 

are reasonably likely to be exposed as 

required for § 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 § 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 

§ 721.63(b), the concentration is set at 

1.0%. For purposes of § 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 § 721.72(a) 

through (f), (g)(1), (g)(3), and (g)(5). For 

purposes of § 721.72(e), the 

concentration is set at 1.0%. For 

purposes of § 721.72(g)(1), this 

substance may cause: skin irritation; eye 

irritation; serious eye damage; specific 

target organ toxicity. For purposes of 

§ 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 § 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 

§ 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 § 721.185 apply to this 

section. 


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Federal Register / Vol. 87, No. 121 / Friday, June 24, 2022 / Proposed Rules 37803 

§ 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 

§ 721.63(a)(1), (a)(3), and (c). When 

determining which persons are 

reasonably likely to be exposed as 

required for § 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 § 721.72(a) 

through (d), (f), (g)(1), and (g)(5). For 

purposes of § 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 § 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 

§ 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 § 721.185 apply to this 

section. 

§ 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 

§ 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 § 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 § 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 § 721.72(a) 

through (d), (f), (g)(1), (g)(3), and (g)(5). 

For purposes of § 721.72(g)(1), this 

substance may cause: eye irritation; skin 

sensitization. For purposes of 

§ 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 § 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 

§ 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 § 721.185 apply to this 

section. 

§ 721.11706 [(Substitutedcarbomonocyclic)amino] oxoalkenoic acid, 

inorganic salt (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as [(substitutedcarbomonocyclic)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 

§ 721.63(a)(1), (a)(3) through (6), and (c). 

When determining which persons are 

reasonably likely to be exposed as 

required for § 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 § 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 

§ 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 § 721.72(a) 

through (d), (f) (g)(1), and (g)(5). For 

purposes of § 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 § 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 

§ 721.125(a) through (i) are applicable to 

manufacturers, importers, and 

processors of this substance. 


jspears on DSK121TN23PROD with PROPOSALS1
37804 Federal Register / Vol. 87, No. 121 / Friday, June 24, 2022 / Proposed Rules 

(2) Limitation or revocation of certain 

notification requirements. The 

provisions of § 721.185 apply to this 

section. 

§ 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 

§ 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 § 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 § 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 § 721.72(e), the 

concentration is set at 1%. For purposes 

of § 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 § 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 

§ 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 § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

(a)(2)(iii) of this section. 

§ 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 

§ 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 § 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 § 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 § 721.72(e), the 

concentration is set at 1%. For purposes 

of § 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 § 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 

§ 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 § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

(a)(2)(iii) of this section. 

§ 721.11709 Sulfonium, triphenyl-, 

polyfluoro-polyhydrospiro[9Hcarbopolycyclic-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[9Hcarbopolycyclic-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 

§ 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 § 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. 


jspears on DSK121TN23PROD with PROPOSALS1
Federal Register / Vol. 87, No. 121 / Friday, June 24, 2022 / Proposed Rules 37805 

(ii) Hazard communication. 

Requirements as specified in § 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 § 721.72(e), the 

concentration is set at 1%. For purposes 

of § 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 § 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 

§ 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 § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

(a)(2)(iii) of this section. 

§ 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 

§ 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 § 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 § 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 § 721.72(e), the 

concentration is set at 1%. For purposes 

of § 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 § 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 

§ 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 § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

(a)(2)(iii) of this section. 

§ 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 

§ 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 § 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 § 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 § 721.72(e), the 

concentration is set at 1%. For purposes 

of § 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 § 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 

§ 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 § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

(a)(2)(iii) of this section. 


jspears on DSK121TN23PROD with PROPOSALS1
37806 Federal Register / Vol. 87, No. 121 / Friday, June 24, 2022 / Proposed Rules 

§ 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 § 720.3(c). 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (a)(3), (b), and (c). When 

determining which persons are 

reasonably likely to be exposed as 

required for § 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 § 721.63(b), the concentration is set at 

1.0%. 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (f), (g)(1), (g)(3), and (g)(5). For 

purposes of § 721.72(e), the 

concentration is set at 1.0%. For 

purposes of § 721.72(g)(1), this 

substance may cause: skin irritation; eye 

irritation; and specific target organ 

toxicity. For purposes of § 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 § 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 

§ 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 § 721.185 apply to this 

section. 

§ 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 heterocyclicpolycarboxylic acid, polyhaloarylpolyhydro-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 

§ 721.63(a)(1), (a)(3), (b), and (c). When 

determining which persons are 

reasonably likely to be exposed as 

required for § 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 § 721.63(b), the concentration is set at 

1.0%. 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (f), (g)(1), (g)(3), and (g)(5). For 

purposes of § 721.72(e), the 

concentration is set at 1.0%. For 

purposes of § 721.72(g)(1), this 

substance may cause: skin irritation; 

acute toxicity; reproductive toxicity; 

specific target organ toxicity. For 

purposes of § 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 § 721.80(o). 

(iv) Release to water. Requirements as 

specified in § 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 

§ 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 § 721.185 apply to this 

section. 

§ 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 

§ 721.63(a)(1), (a)(3) through (6) and (c). 

When determining which persons are 

reasonably likely to be exposed as 

required for § 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 § 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 

§ 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 § 721.72(a) 

through (d), (f), (g)(1), and (g)(5). For 

purposes of § 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 § 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 


jspears on DSK121TN23PROD with PROPOSALS1
Federal Register / Vol. 87, No. 121 / Friday, June 24, 2022 / Proposed Rules 37807 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 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 § 721.185 apply to this 

section. 

§ 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 

§ 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 § 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 § 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 

§ 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/m3 as an 8-hour 

time weighted average. Persons who 

wish to pursue NCELs as an alternative 

to § 721.63 respirator requirements may 

request to do so under § 721.30. Persons 

whose § 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 § 721.72(a) 

through (f), (g)(1), (g)(3), and (g)(5). For 

purposes of § 721.72(e), the 

concentration is set at 1.0%. For 

purposes of § 721.72(g)(1), this 

substance may cause: skin irritation; eye 

irritation; reproductive toxicity; specific 

target organ toxicity; aspiration hazard. 

For purposes of § 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 § 721.80(k). 

(iv) Release to water. Requirements as 

specified in § 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 

§ 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 § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

(a)(2)(iii) of this section. 

[FR Doc. 2022–13360 Filed 6–23–22; 8:45 am] 

BILLING CODE 6560–50–P 


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