102046 Federal Register / Vol. 89, No. 242 / Tuesday, December 17, 2024 / Proposed Rules 

equipment or pollution prevention 

process modifications;’’ section 8.26, 

‘‘Civil or criminal penalties for failure to 

comply;’’ section 8.27, ‘‘Special facilitywide permit provisions;’’ and section 

8.28, ‘‘Delay of testing;’’ as described in 

section II of this preamble. The EPA has 

made, and will continue to make, these 

materials generally available through 

www.regulations.gov and at the EPA 

Region 2 Office (please contact the 

person identified in the FOR FURTHER

INFORMATION CONTACT section of this 

preamble for more information). 

VI. Statutory and Executive Order 

Reviews 

Under the CAA, the Administrator is 

required to approve a SIP submission 

that complies with the provisions of the 

CAA and applicable Federal regulations. 

42 U.S.C. 7410(k); 40 CFR 52.02(a). 

Thus, in reviewing SIP submissions, the 

EPA’s role is to approve state choices, 

provided that they meet the criteria of 

the CAA. Accordingly, this action 

merely proposes to approve State law as 

meeting Federal requirements and does 

not impose additional requirements 

beyond those imposed by State law. For 

that reason, this proposed action: 

• Is not a ‘‘significant regulatory 

action’’ subject to review by the Office 

of Management and Budget under 

Executive Orders 12866 (58 FR 51735, 

October 4, 1993) and 14094 (88 FR 

21879, April 11, 2023); 

• Does not impose an information 

collection burden under the provisions 

of the Paperwork Reduction Act (44 

U.S.C. 3501 et seq.); 

• Is certified as not having a 

significant economic impact on a 

substantial number of small entities 

under the Regulatory Flexibility Act (5 

U.S.C. 601 et seq.); 

• Does not contain any unfunded 

mandate or significantly or uniquely 

affect small governments, as described 

in the Unfunded Mandates Reform Act 

of 1995 (Pub. L. 104–4); 

• Does not have federalism 

implications as specified in Executive 

Order 13132 (64 FR 43255, August 10, 

1999); 

• Is not subject to Executive Order 

13045 (62 FR 19885, April 23, 1997) 

because it approves a state program; 

• Is not a significant regulatory action 

subject to Executive Order 13211 (66 FR 

28355, May 22, 2001); and 

• 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. 

In addition, this proposed SIP will not 

apply on any Indian reservation land or 

in any other area where EPA or an 

Indian Tribe has demonstrated that a 

Tribe has jurisdiction. In those areas of 

Indian country, the rules do 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). 

Executive Order 12898 (Federal 

Actions to Address Environmental 

Justice in Minority Populations and 

Low-Income Populations, 59 FR 7629, 

Feb. 16, 1994) directs Federal agencies 

to identify and address 

‘‘disproportionately high and adverse 

human health or environmental effects’’ 

of their actions on communities with EJ 

concerns to the greatest extent 

practicable and permitted by law. 

Executive Order 14096 (Revitalizing Our 

Nation’s Commitment to Environmental 

Justice for All, 88 FR 25251, April 26, 

2023) builds on and supplements E.O. 

12898 and defines EJ as, among other 

things, the just treatment and 

meaningful involvement of all people, 

regardless of income, race, color, 

national origin, or Tribal affiliation, or 

disability in agency decision-making 

and other Federal activities that affect 

human health and the environment. 

The NJDEP considered EJ as part of its 

SIP submittal given that the CAA and 

applicable implementing regulations 

neither prohibit nor require an 

evaluation. The EPA’s review of the 

NJDEP’s EJ considerations is described 

above in the section titled, 

‘‘Environmental Justice 

Considerations.’’ The consideration was 

done for the purpose of providing 

additional context and information 

about this rulemaking to the public, not 

as a basis of the action. The EPA is 

taking action under the CAA on bases 

independent of the consideration of EJ. 

Due to the nature of the action being 

taken here, this action is expected to 

have a neutral to positive impact on the 

air quality of the affected area. In 

addition, there is no information in the 

record upon which this decision is 

based that is inconsistent with the 

stated goal of E.O. 12898/14096 of 

achieving EJ for communities with EJ 

concerns. 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Ammonia, 

Incorporation by reference, 

Intergovernmental relations, Nitrogen 

oxides, Particulate matter, Reporting 

and recordkeeping requirements, Sulfur 

dioxide, Volatile organic compounds. 

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

Lisa Garcia, 

Regional Administrator, Region 2. 

[FR Doc. 2024–29525 Filed 12–16–24; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 721 

[EPA–HQ–OPPT–2024–0079; FRL–12386– 

01–OCSPP] 

RIN 2070–AB27 

Significant New Use Rules on Certain 

Chemical Substances (24–3.5e) 

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 

certain chemical substances that were 

the subject of premanufacture notices 

(PMNs) and are also subject to an Order 

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 rulemaking to notify EPA at least 90 

days before commencing that activity. 

The required notification initiates EPA’s 

evaluation of the conditions of that use 

for that chemical substance. In addition, 

the manufacture or processing for the 

significant new use may not commence 

until EPA has conducted a review of the 

required notification, made an 

appropriate determination regarding 

that notification, and taken such actions 

as required by that determination. 

DATES: Comments must be received on 

or before January 16, 2025. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPPT–2024–0079, at 

https://www.regulations.gov. Follow the 

online instructions for submitting 

comments. Do not submit electronically 

any information you consider to be 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. Additional 

instructions on commenting and visiting 

the docket, along with more information 

about dockets generally, is available at 

https://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: 

For technical information: Jordan 

Garbin, New Chemicals Division 

(7405M), Office of Pollution Prevention 

and Toxics, Environmental Protection 


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Agency, 1200 Pennsylvania Ave. NW, 

Washington, DC 20460–0001; telephone 

number: (202) 564–4156; email address: 

garbin.jordan@epa.gov. 

For general information on SNURs: 

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 on TSCA: 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. Executive Summary 

A. 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 factors in TSCA section 

5(a)(2) (see also the discussion in Unit 

II.). 

B. What action is the Agency taking? 

EPA is proposing SNURs for the 

chemical substances discussed in Unit 

III. These SNURs, if finalized as 

proposed, would require persons who 

intend to manufacture or process any of 

these chemical substances for an 

activity that is designated as a 

significant new use to notify EPA at 

least 90 days before commencing that 

activity. 

C. Does this action apply to me? 

1. General Applicability 

This action applies to you 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. 

2. Applicability to Importers and 

Exporters 

This action may also apply to certain 

entities through pre-existing import 

certification and export notification 

requirements under TSCA (https:// 

www.epa.gov/tsca-import-exportrequirements). 

Chemical importers are subject to 

TSCA section 13 (15 U.S.C. 2612), the 

requirements in 19 CFR 12.118 through 

12.127, 19 CFR 127.28, and the EPA 

policy in support of import certification 

at 40 CFR part 707, subpart B. Chemical 

importers must certify that the shipment 

of the chemical substance complies with 

all applicable rules and orders under 

TSCA, including regulations issued 

under TSCA sections 5, 6, 7 and Title 

IV. 

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 January 

16, 2025 are subject to TSCA section 

12(b) (15 U.S.C. 2611(b)) and must 

comply with the export notification 

requirements in 40 CFR part 707, 

subpart D. 

D. What are the incremental economic 

impacts of this action? 

EPA has evaluated the potential costs 

of establishing SNUN reporting 

requirements for potential 

manufacturers (including importers) 

and processors of the chemical 

substances subject to these proposed 

SNURs. This analysis, which is 

available in the docket, is briefly 

summarized here. 

1. Estimated Costs for SNUN 

Submissions 

If a SNUN is submitted, costs are an 

estimated $45,000 per SNUN 

submission for large business submitters 

and $14,500 for small business 

submitters. These estimates include the 

cost to prepare and submit the SNUN 

(including registration for EPA’s Central 

Data Exchange (CDX)), and the payment 

of a user fee. Businesses that submit a 

SNUN would be subject to either a 

$37,000 user fee required by 40 CFR 

700.45(c)(2)(ii) and (d), or, if they are a 

small business as defined at 13 CFR 

121.201, a reduced user fee of $6,480 

(40 CFR 700.45(c)(1)(ii) and (d)) per 

fiscal year 2022. The costs of 

submission for SNUNs will not be 

incurred by any company unless a 

company decides to pursue a significant 

new use as defined in these SNURs. 

Additionally, these estimates reflect the 

costs and fees as they are known at the 

time of this rulemaking. 

2. Estimated Costs for Export 

Notifications 

EPA has also evaluated the potential 

costs associated with the export 

notification requirements under TSCA 

section 12(b) and the implementing 

regulations at 40 CFR part 707, subpart 

D. For persons exporting a substance 

that is the subject of a SNUR, a one-time 

notice to EPA must be provided for the 

first export or intended export to a 

particular country. The total costs of 

export notification will vary by 

chemical, depending on the number of 

required notifications (i.e., the number 

of countries to which the chemical is 

exported). While EPA is unable to make 

any estimate of the likely number of 

export notifications for the chemical 

substances covered by these SNURs, as 

stated in the accompanying economic 

analysis, the estimated cost of the export 

notification requirement on a per unit 

basis is approximately $106. 

E. What should I consider as I prepare 

my comments for EPA? 

1. Submitting CBI 

Do not submit CBI to EPA through 

email or https://www.regulations.gov. If 

you wish to include CBI in your 

comment, please follow the applicable 

instructions at https://www.epa.gov/ 

dockets/commenting-epa-dockets#rules 

and clearly mark the information that 

you claim to be CBI. Information so 

marked will not be disclosed except in 

accordance with procedures set forth in 

40 CFR parts 2 and 703. 

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 

This unit provides general 

information about SNURs. For 

additional information about EPA’s new 

chemical program go to https:// 

www.epa.gov/reviewing-new-chemicalsunder-toxic-substances-control-act-tsca. 

A. Significant New Use Determination 

Factors 

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, 


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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, and potential 

human exposures and environmental 

releases that may be associated with the 

substances, in the context of the four 

bulleted TSCA section 5(a)(2) factors 

listed in this unit and discussed in Unit 

III. 

These proposed SNURs 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 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). 

B. Rationale and Objectives of the 

SNURs 

1. Rationale 

Under TSCA, no person may 

manufacture a new chemical substance 

or manufacture or process a chemical 

substance for a significant new use until 

EPA makes a determination as described 

in TSCA section 5(a) and takes any 

required action. The issuance of a SNUR 

is not a risk determination itself, only a 

notification requirement for ‘‘significant 

new uses,’’ so that the Agency has the 

opportunity to review the SNUN for the 

significant new use and make a TSCA 

section 5(a)(3) risk determination. 

During review of the PMNs submitted 

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. Based on the 

findings outlined in Unit III., 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 

significant new uses to ensure that all 

manufacturers and processors—not just 

the original submitter—are held to the 

same standard. 

2. Objectives 

EPA is proposing these SNURs 

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 submitter begins 

manufacturing or processing a listed 

chemical substance for the described 

significant new use. 

• To be obligated to make a 

determination under TSCA section 

5(a)(3) regarding the use described in 

the SNUN, under the conditions of use. 

The Agency will either determine under 

TSCA section 5(a)(3)(C) that the 

significant new use is not likely to 

present an unreasonable risk, including 

an unreasonable risk to a potentially 

exposed or susceptible subpopulation 

identified as relevant by the 

Administrator under the conditions of 

use, or make a determination under 

TSCA section 5(a)(3)(A) or (B) and take 

the required regulatory action associated 

with the determination, before 

manufacture or processing for the 

significant new use of the chemical 

substance can occur. 

Issuance of a proposed 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 at 

https://www.epa.gov/tsca-inventory. 

C. Significant New Uses Claimed as CBI 

EPA is proposing to establish certain 

significant new uses which have been 

claimed as CBI subject to Agency 

confidentiality regulations at 40 CFR 

part 2 and 40 CFR part 703. Absent a 

final determination or other disposition 

of the confidentiality claim under these 

regulations, EPA is required to keep this 

information confidential. EPA 

promulgated a procedure at 40 CFR 

721.11 to deal with the situation where 

a specific significant new use is CBI. 

Under these procedures. a manufacturer 

or processor may request EPA to 

identify the confidential significant new 

use under the rule. The manufacturer or 

processor must show that it has a bona 

fide intent to manufacture or process the 

chemical substance. If EPA concludes 

that the person has shown a bona fide 

intent to manufacture or process the 

chemical substance, EPA will identify 

the confidential significant new use to 

that person. Since most of the chemical 

identities of the chemical substances 

subject to these SNURs are also CBI, 

manufacturers and processors can 

combine the bona fide submission 

under the procedure in 40 CFR 721.11 

into a single step. 

D. Applicability of General Provisions 

General provisions for SNURs appear 

in 40 CFR part 721, subpart A. These 

provisions describe persons subject to 

SNURs, recordkeeping requirements, 

exemptions to reporting requirements, 

and applicability of the rule to uses 

occurring before the effective date of the 

rule. Pursuant to 40 CFR 721.1(c), 

persons subject to SNURs must comply 

with the same requirements and EPA 

regulatory procedures as submitters of 

PMNs under TSCA section 5(a)(1)(A). In 

particular, 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), 5(h)(2), 5(h)(3), 

and 5(h)(5) and the regulations at 40 

CFR part 720. In addition, provisions 

relating to user fees appear at 40 CFR 

part 700. 

Once EPA receives a SNUN, EPA 

must either determine that the 

significant new 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 under 

TSCA section 5 before the manufacture 

(including import) or processing for the 

significant new use can commence. If 

EPA determines that the significant new 

use of the chemical substance 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. 

As discussed in Unit I.C.2., persons 

who export or intend to export a 

chemical substance identified in a 

proposed or final SNUR are subject to 

the export notification provisions of 

TSCA section 12(b), and persons who 

import a chemical substance identified 

in a final SNUR are subject to the TSCA 

section 13 import certification 

requirements. See also https://

www.epa.gov/tsca-import-exportrequirements. 

E. Applicability of the Proposed SNURs 

to Uses Occurring Before the Effective 

Date of the Final Rule 

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 and 


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received determinations under TSCA 

section 5(a)(3)(C). TSCA Orders have 

been issued for these chemical 

substances and the PMN submitters are 

required by the TSCA Orders to submit 

a SNUN before undertaking activities 

that would be designated as significant 

new uses in these SNURs. Additionally, 

the identities of many of the chemical 

substances subject to this proposed rule 

have been claimed as confidential per 

40 CFR 720.85, further reducing the 

likelihood that another party would 

manufacture or process the substances 

for an activity that would be designated 

as a significant new use. Based on this, 

the Agency believes that it is highly 

unlikely that any of the significant new 

uses identified in Unit III. are ongoing. 

When the chemical substances 

identified in Unit III. 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. 

Persons who begin manufacture or 

processing of the chemical substances 

for a significant new use identified on 

or after the designated cutoff date 

specified in Unit III.A. 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 EPA would have to 

take action under TSCA section 5 

allowing manufacture or processing to 

proceed. 

F. Important Information About SNUN 

Submissions 

1. SNUN Submissions 

SNUNs must be submitted on EPA 

Form No. 7710–25, generated using ePMN software, and submitted to the 

Agency in accordance with the 

procedures set forth in 40 CFR 720.40 

and 721.25. E–PMN software is 

available electronically at https://

www.epa.gov/reviewing-new-chemicalsunder-toxic-substances-control-act-tsca. 

2. Development and Submission of 

Information 

EPA recognizes that TSCA section 5 

does not require development of any 

particular new information (e.g., 

generating test data) before submission 

of a SNUN. There is an exception: If a 

person is required to submit information 

for a chemical substance pursuant to a 

rule, order or consent agreement under 

TSCA section 4, 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 to or reasonably 

ascertainable by them (see 40 CFR 

720.50). However, upon review of PMNs 

and SNUNs, the Agency has the 

authority to require appropriate testing. 

To assist with EPA’s analysis of the 

SNUN, submitters are encouraged, but 

not required, to provide the potentially 

useful information identified for the 

chemical substance in Unit III.C. 

EPA strongly encourages persons, 

before performing any testing, to consult 

with the Agency pertaining to protocol 

selection. Furthermore, pursuant to 

TSCA section 4(h), which pertains to 

reduction of testing in vertebrate 

animals, EPA encourages consultation 

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-andmanaging-chemicals-under-tsca/ 

alternative-test-methods-and-strategiesreduce. 

The potentially useful information 

described in Unit III. may not be the 

only means of providing information to 

evaluate the chemical substance 

associated with the significant new 

uses. However, submitting a SNUN 

without any test data may increase the 

likelihood that EPA will take action 

under TSCA sections 5(e) or 5(f). EPA 

recommends that potential SNUN 

submitters contact EPA early enough so 

that they will be able to conduct the 

appropriate tests. 

SNUN submitters should be aware 

that EPA will be better able to evaluate 

SNUNs that provide detailed 

information on the human exposure and 

environmental release that may result 

from the significant new use of the 

chemical substances. 

III. Chemical Substances Subject to 

These Proposed SNURs 

A. What is the designated cutoff date for 

ongoing uses? 

EPA designates December 17, 2024 as 

the cutoff date for determining whether 

the new use is ongoing. This 

designation is explained in more detail 

in Unit II.E. 

B. What information is provided for 

each chemical substance? 

For each chemical substance 

identified in Unit III.C., EPA provides 

the following information: 

• PMN number (the proposed CFR 

citation assigned in the regulatory text 

section of the proposed rule). 

• Chemical name (generic name, if 

the specific name is claimed as CBI). 

• Chemical Abstracts Service Registry 

Number (CASRN) (if assigned for nonconfidential chemical identities). 

• Basis for the action (effective date of 

and basis for the TSCA Order). 

• Potentially useful information. 

The regulatory text section of the 

proposed rule specifies the activities 

designated as significant new uses. 

Certain new uses, including production 

volume limits and other uses designated 

in the proposed rules, may be claimed 

as CBI. 

These proposed rules include PMN 

substances that are subject to orders 

issued under TSCA section 5(e)(1)(A), as 

required by the determinations made 

under TSCA section 5(a)(3)(B). Those 

TSCA Orders require protective 

measures to limit exposures or 

otherwise mitigate the potential 

unreasonable risk. The proposed SNURs 

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). 

C. Which chemical substances are 

subject to these proposed rules? 

The substances subject to the 

proposed rules in this document are as 

follows: 

PMN Number (Proposed CFR Citation): 

P–18–127 (40 CFR 721.12043) 

Chemical Name: Heptane, 2-methoxy2-methyl-. 

CASRN: 76589–16–7. 

Effective Date of TSCA Order: 

December 15, 2023. 

Basis for TSCA Order: The PMN states 

that the use will be as a fragrance for 

household and consumer products, 

mainly laundry detergents. Based on 

submitted test data on the PMN 

substance, EPA has identified concerns 

for skin sensitization. Based on 

comparison to analogous chemical 

substances, EPA has also identified 

concerns for systemic and 

developmental effects. Based on 

submitted test data on the PMN 

substance, EPA predicts toxicity to 


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aquatic organisms may occur at 

concentrations that exceed 210 ppb. The 

Order was issued under TSCA sections 

5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), 

based on a finding that in the absence 

of sufficient information to permit a 

reasoned evaluation, the substance may 

present an unreasonable risk of injury to 

human health and the environment. To 

protect against these risks, the Order 

requires: 

• Manufacture of the PMN substance 

only by import into the United States in 

a solution of no greater than 5% by 

weight (i.e., no domestic manufacture); 

• Processing of the PMN substance 

only in a solution of no greater than 5% 

by weight of the PMN substance; 

• Processing for use or use of the 

PMN substance in consumer products 

only if the concentration of the PMN 

substance is less than 1% by weight; 

• No release of the PMN substance, or 

any waste stream containing the PMN 

substance, in surface water 

concentrations that exceed 210 ppb; 

• 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 

developmental toxicity, specific target 

organ toxicity, and pulmonary effects 

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. 

PMN Number (Proposed CFR Citation): 

P–18–325 (40 CFR 721.12044) 

Chemical Name: Benzenesulfonic 

acid, alkyl-, compd. with 1,1′- 

iminobis[2-propanol] (1:1) (generic). 

CASRN: Not available. 

Effective Date of TSCA Order: January 

9, 2024. 

Basis for TSCA Order: The PMN states 

that the use will be as an industrial 

crosslinking catalyst. Based on the 

structure of the anion, EPA identified 

concerns for lung toxicity (surfactant 

effects). Based on test data for the 

neutral form of the cation and analogues 

for the anion, EPA also identified 

concerns for skin and eye irritation, and 

systemic and reproductive effects. Based 

on comparison to analogous anionic 

surfactants, EPA predicts toxicity to 

aquatic organisms may occur at 

concentrations that exceed 0.4 ppb. The 

Order was issued under TSCA sections 

5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), 

based on a finding that in the absence 

of sufficient information to permit a 

reasoned evaluation, the substance may 

present an unreasonable risk of injury to 

human health and the environment. To 

protect against these risks, the Order 

requires: 

• No manufacture, processing, or use 

of the PMN substance in any manner 

that results in inhalation exposure to the 

PMN substance; 

• No processing for use or use of the 

PMN substance other than as an 

industrial cross-linking catalyst; 

• No release of the PMN substances, 

or any waste stream containing the PMN 

substances, into waters of the United 

States; 

• 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 skin 

irritation/corrosion, eye irritation/ 

corrosion, pulmonary effects, 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. 

PMN Number (Proposed CFR Citation): 

P–20–14 (40 CFR 721.12045) 

Chemical Name: Sugars, polymer 

with alkanetriamine (generic). 

CASRN: Not available. 

Effective Date of TSCA Order: January 

27, 2023. 

Basis for TSCA Order: The PMN states 

that the generic (non-confidential) use 

will be as a water resistant resin 

additive. Based on comparison to 

analogous chemical substances, EPA has 

identified concerns for systemic effects 

(body weight). Based on potential 

chelation to nutrient metals, EPA has 

also identified concerns for 

developmental and systemic effects. 

Based on submitted test data on the 

PMN substance, EPA predicts toxicity to 

aquatic organisms may occur at 

concentrations that exceed 191 ppb. The 

Order was issued under TSCA sections 

5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), 

based on a finding that in the absence 

of sufficient information to permit a 

reasoned evaluation, the substance may 

present an unreasonable risk of injury to 

human health and the environment. To 

protect against these risks, the Order 

requires: 

• No use of the PMN substance in a 

consumer product; 

• No release of the PMN substance, or 

any waste stream containing the PMN 

substance, in surface water 

concentrations that exceed 191 ppb; 

• 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 

reproductive toxicity and specific target 

organ 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. 

PMN Number (Proposed CFR Citation): 

P–21–86 (40 CFR 721.12046) 

Chemical Name: Isooctadecanamide, 

N,N-bis(2-ethylhexyl)-. 

CASRN: 1616494–50–8. 

Effective Date of TSCA Order: 

February 6, 2024. 

Basis for TSCA Order: The PMN states 

that the generic (non-confidential) use 

will be as an automotive engine 


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additive. Based on test data for the 

metabolite, EPA has identified concerns 

for systemic 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 processing for use of the PMN 

substance in a consumer product where 

the concentration of the PMN substance 

in the consumer product formulation 

exceeds the confidential percentage 

listed in the Order; 

• No use of the PMN substance in a 

consumer product where the 

concentration of the PMN substance 

exceeds the confidential percentage 

listed in the Order; 

• 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 

metabolism or pharmacokinetics 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. 

PMN Number (Proposed CFR Citation): 

P–21–164 (40 CFR 721.12047) 

Chemical Name: 2-Butanone, oxime, 

reaction products with 

trimethoxymethylsilane. 

CASRN: 2639393–45–4. 

Effective Date of TSCA Order: 

November 13, 2023. 

Basis for TSCA Order: The PMN states 

that the use will be as a crosslinker for 

waterproofing. Based on comparison to 

analogous chemical substances, EPA has 

identified concerns for irritation to skin 

and eyes and systemic effects. Based on 

test data for hydrolysis products, EPA 

has also identified concerns for acute 

toxicity, skin irritation, eye corrosion, 

respiratory tract irritation and corrosion, 

skin sensitization, systemic effects, 

developmental effects, neurotoxicity 

and carcinogenicity. Based on test data 

for hydrolysis products, EPA predicts 

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 and the 

environment. To protect against these 

risks, the Order requires: 

• No use of the PMN substance unless 

at 4% or less by weight in formulation; 

• No loading or unloading of the 

PMN substance for manufacture, 

processing, or use unless under a gas 

(e.g., nitrogen) blanket; 

• Application of the PMN substance 

for use only by roll, brush, or dip 

coating; 

• Use of personal protective 

equipment where there is a potential for 

dermal exposure; 

• Use of a NIOSH-certified 

combination particulate and gas/vapor 

respirator with an APF of at least 50 

where there is a potential for inhalation 

exposure; 

• Disposal of the PMN substance, or 

waste streams containing the PMN 

substance, only by incineration; 

• No release of the PMN substance, or 

any waste stream containing the PMN 

substance, into waters of the United 

States; 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 acute 

toxicity, carcinogenicity, eye damage, 

pulmonary effects, 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. 

PMN Number (Proposed CFR Citation): 

P–21–170 (40 CFR 721.12048) 

Chemical Name: 2,6-Bis(dialkyl)-4-[2- 

(1-alkyl-4(1H)- 

pyridinylidene)alkylidene]-2,5- 

cycloalkyladien-1-one (generic). 

CASRN: Not available. 

Effective Date of TSCA Order: January 

27, 2024. 

Basis for TSCA Order: The PMN states 

that the use will be as a color indicator 

for frying oil breakdown. Based on 

comparison to analogous chemical 

substances, EPA has identified concerns 

for irritation to skin and eyes, skin 

sensitization, neurotoxicity, systemic 

effects (respiratory tract, lung, liver, 

kidney, spleen, and body weight 

effects), reproductive and 

developmental effects, genotoxicity, 

carcinogenicity, and acute toxicity 

(mortality). Based on OECD Toolbox 

results, EPA identified concerns for skin 

sensitization and based on information 

provided in the SDS, EPA has also 

identified concerns for acute toxicity 

and irritation to skin, eyes, and 

respiratory tract. Based on comparison 

to analogous chemical substances, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

1 ppb. The Order was issued under 

TSCA sections 5(a)(3)(B)(ii)(I) and 

5(e)(1)(A)(ii)(I), based on a finding that 

in the absence of sufficient information 

to permit a reasoned evaluation, the 

substance may present an unreasonable 

risk of injury to human health and the 

environment. To protect against these 

risks, the Order requires: 

• Manufacture of the PMN substance 

only below an annual volume of 10 kg; 

• No manufacture, processing, or use 

of the PMN substance resulting in 

releases to air except with the use of a 

HEPA filtration system; 

• No processing for use or use of the 

PMN substance other than as a color 

indicator for frying oil breakdown; 

• No processing for use or use of the 

PMN substance where the concentration 

of the PMN substance in the final 

product exceeds 0.008%; 

• No release of the PMN substance, or 

any waste stream containing the PMN 

substance, into waters of the United 

States; 

• Use of a NIOSH-certified particulate 

respirator with an APF of at least 10 

where there is a potential for inhalation 

exposure; 

• 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. 


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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 

biodegradation, bioaccumulation, log P, 

and aquatic toxicity testing may be 

potentially useful to characterize the 

physical/chemical properties and 

environmental fate/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. 

PMN Number (Proposed CFR Citation): 

P–21–184 (40 CFR 721.12049) 

Chemical Name: Fatty acids, soya, 

reaction products with ammoniaethanolamine reaction by-products. 

CASRN: 2378512–59–3. 

Effective Date of TSCA Order: 

November 16, 2023. 

Basis for TSCA Order: The PMN states 

that the generic (non-confidential) use 

will be in asphalt emulsion 

applications. Based on comparison to 

analogous chemical substances, EPA has 

identified concerns for acute toxicity, 

skin and eye irritation/corrosion, skin 

sensitization, point-of-contact effects, 

lung effects, and systemic effects. Based 

on the surfactant-like properties of the 

PMN substance and its use as an 

emulsifier, EPA has also identified 

concerns for lung effects (surfactancy). 

Based on information in the SDS, EPA 

has also identified concerns for skin 

irritation, eye corrosion, and respiratory 

irritation. Based on comparison to 

analogous aliphatic amines, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

2 ppb. The Order was issued under 

TSCA sections 5(a)(3)(B)(ii)(I) and 

5(e)(1)(A)(ii)(I), based on a finding that 

in the absence of sufficient information 

to permit a reasoned evaluation, the 

substance may present an unreasonable 

risk of injury to human health and the 

environment. To protect against these 

risks, the Order requires: 

• No manufacture, processing, or use 

of the PMN substance in any manner 

that results in the generation of vapor, 

mist, dust, or aerosol; 

• No processing for use or use of the 

PMN substance in a consumer product; 

• Use of personal protective 

equipment where there is a potential for 

dermal exposure; 

• No release of the PMN substance, or 

any waste stream containing the PMN 

substance, in surface water 

concentrations that exceed 2 ppb; 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 acute 

toxicity, specific target organ toxicity, 

pulmonary effects, skin irritation/ 

corrosion, eye damage, neurotoxicity, 

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. 

PMN Numbers (Proposed CFR 

Citations): P–22–3 (40 CFR 721.12050), 

P–22–4 (40 CFR 721.12051), P–22–5 (40 

CFR 721.12052), and P–22–6 (40 CFR 

721.12053) 

Chemical Names: 1,5- 

Pentanediamine, 2-methyl-, 

hydrochloride (1:2) (P–22–3), 1,5- 

Pentanediamine, 2-methyl-, 

hydrochloride (1:1) (P–22–4), Formic 

acid, compd. with 2-methyl-1,5- 

pentanediamine (2:1) (P–22–5), and 

Formic acid, compd. with 2-methyl-1,5- 

pentanediamine (1:1) (P–22–6). 

CASRNs: 34813–63–3 (P–22–3), 

1840915–04–9 (P–22–4), 1836131–73–7 

(P–22–5), and 1836131–75–9 (P–22–6). 

Effective Date of TSCA Order: 

December 4, 2023. 

Basis for TSCA Order: The PMNs state 

that the uses will be as clay stabilizers 

for oil and gas fracking. Based on 

submitted test data on the P–22–3 

substance, comparison to analogous 

chemical substances, structure and 

expected acidity or basicity of 

components, physical/chemical 

properties of components, and 

information provided in the SDS, EPA 

has identified concerns for acute 

toxicity, irritation or corrosion to skin, 

eyes, and respiratory tract, and systemic 

effects. Based on submitted test data for 

the P–22–3 substance, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 570 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 and the 

environment. To protect against these 

risks, the Order requires: 

• No processing for use or use of the 

PMN substances in consumer products; 

• No manufacture, processing, or use 

of the PMN substances in any manner 

that results in inhalation exposure to the 

PMN substances; 

• Use of personal protective 

equipment where there is a potential for 

dermal exposure; 

• No release of the PMN substances, 

or any waste stream containing the PMN 

substances, in surface water 

concentrations that exceed 570 ppb 

combined; 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 eye 

irritation/corrosion, skin irritation/ 

corrosion, specific target organ toxicity, 

pulmonary effects, and aquatic toxicity 

testing may be potentially useful to 

characterize the health and 

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. 

PMN Number (Proposed CFR Citation): 

P–22–11 (40 CFR 721.12054) 

Chemical Name: Alkadiene, 

homopolymer, hydroxy-terminated, 

bis[N-[2-[(1-oxo-2-propen-1- 

yl)oxylethyl]carbamates] (generic). 

CASRN: Not available. 

Effective Date of TSCA Order: 

November 27, 2023. 

Basis for TSCA Order: The PMN states 

that the generic (non-confidential) use 

will be as a functionalized rubber in the 

resin side of two component epoxy 


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modified acrylic adhesive and as a 

functionalized rubber in the resin side 

of two component acrylic adhesive. 

Based on test data on one or both of the 

two components in the formulation, 

EPA has identified concerns for skin 

sensitization, and systemic, 

reproductive, and developmental 

effects. Based on the weight of the 

scientific evidence, EPA has also 

identified concerns for respiratory 

sensitization. Based on information in 

the SDS, EPA has also identified 

concerns for skin sensitization and 

reproductive 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. To protect against these 

risks, the Order requires: 

• 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; 

• 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 skin 

sensitization, developmental toxicity, 

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. 

PMN Number (Proposed CFR Citation): 

P–22–25 (40 CFR 721.12055) 

Chemical Name: Oxirane, 2- 

(chloromethyl)-, homopolymer, ether 

with dialkyl-alkanediol (2:1) (generic). 

CASRN: Not available. 

Effective Date of TSCA Order: 

February 20, 2024. 

Basis for TSCA Order: The PMN states 

that the use will be as a chemical 

intermediate. Based on comparison to 

analogous chemical substances and 

structural alerts, EPA has identified 

concerns for acute toxicity, irritation to 

the respiratory tract, skin, and eyes, 

systemic effects, genetic toxicity, and 

carcinogenicity. 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 exceedance of the confidential 

annual production volume listed in the 

Order; 

• No manufacture, processing, or use 

of the PMN substance in any manner 

that results in the generation of a vapor, 

mist, dust, or aerosol; 

• Use of the PMN substance only as 

a chemical intermediate; 

• Disposal of the PMN substance, or 

waste streams containing the PMN 

substance, only by hazardous waste 

incineration; 

• No release of the PMN substance, or 

any waste stream containing the PMN 

substance, into waters of the United 

States; 

• 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 acute 

toxicity, specific target organ toxicity, 

pulmonary effects, eye irritation, skin 

irritation, genetic toxicity, and 

carcinogenicity 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. 

PMN Number (Proposed CFR Citation): 

P–22–49 (40 CFR 721.12056) 

Chemical Name: Aryl, polymer with 

formaldehyde, glycidyl ether, reaction 

products with amino alkyl-alkane 

diamine, cyclohexanediamine and 

alkylene (alkylcyclohexanamine) 

(generic). 

CASRN: Not available. 

Effective Date of TSCA Order: January 

11, 2024. 

Basis for TSCA Order: The PMN states 

that the use will be as a hardener in 

coatings for oil and gas, power, and 

chemical/petrochemical industries for 

tank and pipe linings and for asset 

protection, in coatings in wastewater 

applications industries for tank and 

pipe linings and for asset protection, in 

coatings used in manufacturing 

industries for tank and pipe linings and 

for asset protection, and in OEM 

automotive and heavy industrial 

machinery coatings. Based on submitted 

test data on the PMN substance, EPA 

has identified concerns for acute 

toxicity. Based on residual data, EPA 

has also identified concerns for 

irritation to the skin, eye, and 

respiratory tract, skin and respiratory 

sensitization, systemic, developmental, 

and reproductive effects, corrosion to all 

tissues, and genetic toxicity. Based on 

submitted test data on the PMN 

substance and comparison to analogous 

polycationic polymers, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 2 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, or 

any waste stream containing the PMN 

substance, in surface water 

concentrations that exceed 2 ppb; 

• 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 

consumer product; 

• 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 


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determined that the results of skin 

irritation, skin corrosion, eye irritation, 

eye corrosion, 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. 

PMN Number (Proposed CFR Citation): 

P–22–50 (40 CFR 721.12057) 

Chemical Name: Alkene, alkoxy-, 

polymer with alkoxyalkene (generic). 

CASRN: Not available. 

Effective Date of TSCA Order: January 

8, 2024. 

Basis for TSCA Order: The PMN states 

that the generic (non-confidential) use 

will be as a lubricant. Based on 

comparison to analogous chemical 

substances, EPA has identified concerns 

for skin, eye, and respiratory tract 

irritation and systemic effects. Based on 

comparison to analogous neutral 

organics, EPA predicts toxicity to 

aquatic organisms may occur at 

concentrations that exceed 32 ppb. The 

Order was issued under TSCA sections 

5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), 

based on a finding that in the absence 

of sufficient information to permit a 

reasoned evaluation, the substance may 

present an unreasonable risk of injury to 

human health and the environment. To 

protect against these risks, the Order 

requires: 

• No processing for use or 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 to the 

PMN substance; 

• No processing for use or use of the 

PMN substance other than for the 

confidential use listed in the Order; 

• No release of the PMN substance, or 

any waste stream containing the PMN 

substance, into waters of the United 

States; 

• 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 specific 

target organ toxicity, skin irritation, eye 

irritation, 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. 

PMN Number (Proposed CFR Citation): 

P–22–58 (40 CFR 721.12058) 

Chemical Name: 

Methanesulfonamide, 1,1,1-trifluoro-N- 

[(trifluoromethyl)sulfonyl]-, sodium salt 

(1:1). 

CASRN: 91742–21–1. 

Effective Date of TSCA Order: 

February 13, 2024. 

Basis for TSCA Order: The PMN states 

that the generic (non-confidential) use 

will be as a process chemical. Based on 

submitted test data on the PMN 

substance, EPA has identified concerns 

for acute toxicity and serious eye 

damage. Based on comparison to 

analogous chemical substances, EPA has 

also identified concerns for respiratory 

tract and skin irritation, neurotoxicity, 

systemic, reproductive, and 

developmental effects. Based on 

comparison to analogous chemical 

substances, EPA has also identified 

concerns for respiratory, systemic, and 

neurological effects for the potential 

incineration product of the anion. Based 

on submitted test data on the PMN 

substance and comparison to analogous 

substances, EPA predicts toxicity to 

aquatic organisms may occur at 

concentrations that exceed 140 ppb. The 

Order was issued under TSCA sections 

5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), 

based on a finding that in the absence 

of sufficient information to permit a 

reasoned evaluation, the substance may 

present an unreasonable risk of injury to 

human health and the environment. To 

protect against these risks, the Order 

requires: 

• No manufacture of the PMN 

substance other than in an enclosed 

process; 

• No processing or use of the PMN 

substance other than in a manner that 

does not generate a vapor, mist, dust, or 

aerosol that results in inhalation 

exposure to workers; 

• No use of the PMN substance other 

than for the confidential use listed in 

the Order; 

• No use of the PMN substance other 

than in the form of a liquid; 

• No release of the PMN substance, or 

any waste stream containing the PMN 

substance, in surface water 

concentrations that exceed 100 ppb; 

• Use of a NIOSH-certified 

combination particulate and gas/vapor 

respirator with an APF of at least 50 

where there is a potential for inhalation 

exposure; 

• 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 specific 

target organ toxicity, pulmonary effects, 

reproductive toxicity, developmental 

toxicity, neurotoxicity, sediment 

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. 

PMN Number (Proposed CFR Citation): 

P–22–75 (40 CFR 721.12059) 

Chemical Name: 1H-Isoindole1,3(2H)-dione, 3a,4,7,7a-tetrahydro-2-(2- 

hydroxyethyl)-. 

CASRN: 15458–48–7. 

Effective Date of TSCA Order: January 

19, 2024. 

Basis for TSCA Order: The PMN states 

that the use will be as a monomer used 

to produce an unsaturated polyester 

resin. Based on comparison to 

analogous chemical substances, EPA has 

identified concerns for acute toxicity, 

skin and eye irritation, and systemic 

effects. Based on comparison to 

analogous imides, EPA predicts toxicity 

to aquatic organisms may occur at 

concentrations that exceed 21 ppb. The 

Order was issued under TSCA sections 

5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), 

based on a finding that in the absence 

of sufficient information to permit a 

reasoned evaluation, the substance may 

present an unreasonable risk of injury to 

human health and the environment. To 

protect against these risks, the Order 

requires: 


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• Manufacture of the PMN substance 

only at or below an annual volume of 

3,000 kg; 

• No domestic manufacture of the 

PMN substance (i.e., import only); 

• No use of the PMN substance other 

than as a monomer used to produce an 

unsaturated polyester resin; 

• 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 acute 

toxicity, eye irritation, skin irritation, 

pulmonary effects, 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. 

PMN Number (Proposed CFR Citation): 

P–22–78 (40 CFR 721.12060) 

Chemical Name: Oxirane, 2-methyl-, 

polymer with oxirane, mono-isoalkyl 

ethers, phosphates, salt (generic). 

CASRN: Not available. 

Effective Date of TSCA Order: 

November 27, 2023. 

Basis for TSCA Order: The PMN states 

that the use will be as a dispersing agent 

for pesticide formulations. Based on 

structure, EPA has identified concerns 

for lung effects (surfactancy). Based on 

comparison to analogous chemical 

substances, EPA has also identified 

concerns for skin irritation and systemic 

effects. Based on comparison to 

analogous anionic surfactants, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

23 ppb. The Order was issued under 

TSCA sections 5(a)(3)(B)(ii)(I) and 

5(e)(1)(A)(ii)(I), based on a finding that 

in the absence of sufficient information 

to permit a reasoned evaluation, the 

substance may present an unreasonable 

risk of injury to human health and the 

environment. To protect against these 

risks, the Order requires: 

• No processing for use or use of the 

PMN substance other than as a 

dispersing agent for pesticide 

formulations; 

• No manufacture or processing of the 

PMN substance in any manner that 

results in the generation of a vapor, 

mist, dust, or aerosol; 

• Use of personal protective 

equipment where there is a potential for 

dermal exposure; 

• No release of the PMN substance, or 

any waste stream containing the PMN 

substance, in surface water 

concentrations that exceed 23 ppb; 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 

pulmonary effects, 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. 

PMN Number (Proposed CFR Citation): 

P–22–80 (40 CFR 721.12061) 

Chemical Name: Poly(oxy-1,2- 

ethanediyl), .alpha.-(2-aminoethyl)- 

.omega.-(2-aminoethoxy)- and Poly(oxy1,2-ethanediyl), .alpha.,.alpha.′,- 

(iminodi-2,1- ethanediyl)bis[.omega.-(2- 

aminoethoxy)-. 

CASRNs: 24991–53–5 and 90350–34– 

8. 

Effective Date of TSCA Order: 

December 1, 2023. 

Basis for TSCA Order: The PMN states 

that the use will be as an industrial 

intermediate used in the manufacture of 

polyamides as a monomer. Based on the 

pH of the PMN substance, EPA has 

identified concerns for skin, eye, and 

respiratory tract corrosion. Based on 

comparison to analogous chemical 

substances, EPA has also identified 

concerns for acute toxicity and skin 

sensitization. Based on comparison to 

analogous polycationic polymers, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

0.7 ppb. The Order was issued under 

TSCA sections 5(a)(3)(B)(ii)(I) and 

5(e)(1)(A)(ii)(I), based on a finding that 

in the absence of sufficient information 

to permit a reasoned evaluation, the 

substance may present an unreasonable 

risk of injury to human health and the 

environment. To protect against these 

risks, the Order requires: 

• No manufacture, processing, or use 

of the PMN substance in any manner 

that results in inhalation exposure; 

• No release of the PMN substance, or 

any waste stream containing the PMN 

substance, in surface water 

concentrations that exceed 0.7 ppb; 

• 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 acute 

toxicity, skin corrosion, eye corrosion, 

pulmonary effects, 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. 

PMN Number (Proposed CFR Citation): 

P–22–82 (40 CFR 721.12062) 

Chemical Name: Alkenoic acid, alkyl, 

carbopolycyclic alkyl ester, polymer 

with trihalo (trihaloalkyl) alkyl alkyl 

alkenoate (generic). 

CASRN: Not available. 

Effective Date of TSCA Order: 

November 3, 2023. 

Basis for TSCA Order: The PMN states 

that the generic (non-confidential) use 

will be as a component of photoresist. 

Based on test data on the degradation 

product and an analogue of the 

degradation product, EPA has identified 

concerns for neurotoxicity, 

reproductive, developmental, and 

systemic effects. Based on the potential 

incineration product, EPA has also 

identified concerns for systemic effects, 

and neurotoxicity. The Order was 

issued under TSCA sections 


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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 manufacture of the PMN 

substance other than by import into the 

United States (i.e., no domestic 

manufacture) in a liquid formulation; 

• No processing or use of the PMN 

substance other than in a liquid 

formulation; 

• Use of the PMN substance only for 

the confidential use listed in the Order; 

• No release of the PMN substance, or 

any waste stream containing the PMN 

substance, into waters of the United 

States; 

• Disposal of the PMN substance, or 

waste streams containing the PMN 

substance, only by incineration; 

• 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 

pulmonary effects, reproductive and 

developmental effects, and 

neurotoxicity 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. 

PMN Number (Proposed CFR Citation): 

P–22–121 (40 CFR 721.12063) 

Chemical Name: Polychloroalkene 

(generic). 

CASRN: Not available. 

Effective Date of TSCA Order: 

February 6, 2024. 

Basis for TSCA Order: The PMN states 

that the generic (non-confidential) use 

will be as a process intermediate. Based 

on submitted test data on the PMN 

substance and information in the SDS, 

EPA has identified concerns for acute 

toxicity (oral) and skin sensitization. 

Based on test data for analogues, EPA 

identified concerns for acute toxicity 

(oral, inhalation), skin irritation, eye 

corrosion, respiratory irritation, 

genotoxicity, carcinogenicity, and 

systemic effects. Based on submitted 

acute test data and comparison to 

analogous chemical substances, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

0.15 ppb. The Order was issued under 

TSCA sections 5(a)(3)(B)(ii)(I) and 

5(e)(1)(A)(ii)(I), based on a finding that 

in the absence of sufficient information 

to permit a reasoned evaluation, the 

substance may present an unreasonable 

risk of injury to human health and the 

environment. To protect against these 

risks, the Order requires: 

• No domestic manufacture of the 

PMN substance (i.e., import only); 

• No processing, use, loading, or 

unloading of the PMN substance unless 

under a gas (e.g., nitrogen) blanket or in 

a closed system except that sampling 

may occur outside the closed system 

resulting in exposures; 

• No use of the PMN substance other 

than for the confidential use listed in 

the Order; 

• Use of a NIOSH-certified 

combination particulate and gas/vapor 

respirator with an APF of at least 50 

where there is a potential for inhalation 

exposure; 

• Use of personal protective 

equipment where there is a potential for 

dermal exposure; 

• No release of the PMN substance, or 

any waste stream containing the PMN 

substance, in surface water 

concentrations that exceed 0.15 ppb; 

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 

carcinogenicity, eye irritation/corrosion, 

genetic toxicity, pulmonary effects, skin 

irritation, specific target organ toxicity, 

toxicokinetics, 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. 

PMN Number (Proposed CFR Citation): 

P–22–145 (40 CFR 721.12064) 

Chemical Name: Alkanoic acid, 

trialkyl-, diester with carbomonocycle 

bis(alkyleneoxy)]bis[alkanediol] 

(generic). 

CASRN: Not available. 

Effective Date of TSCA Order: 

February 21, 2024. 

Basis for TSCA Order: The PMN states 

that the use will be as a reactive-diluent 

in a polyol component of a 2K 

(Isocyanate-Polyol) Urethane coating 

system for interior concrete floor sealant 

or interior/exterior paver sealer. 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 

six months and estimates a 

bioconcentration factor of greater than 

or equal to 5,000. Based on test data for 

a potential hydrolysis product, EPA has 

identified concerns for acute toxicity 

and systemic, reproductive, and 

developmental effects. Based on 

comparison to analogous esters, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

0.14 ppb. The Order was issued under 

TSCA sections 5(a)(3)(B)(ii)(I) and 

5(e)(1)(A)(ii)(I), based on a finding that 

in the absence of sufficient information 

to permit a reasoned evaluation, the 

substance may present an unreasonable 

risk of injury to human health and the 

environment. To protect against these 

risks, the Order requires: 

• No use of the PMN substance in any 

manner that generates a spray, mist, 

vapor, or aerosol containing the PMN 

substance unless the concentration of 

the PMN substance is less than 5.7% by 

weight; 

• No processing for use or use of the 

PMN substance in a consumer product; 

• No release of the PMN substance, or 

any waste stream containing the PMN 

substance, into waters of the United 

States; 

• Disposal of the PMN substance, or 

waste streams containing the PMN 

substance, only by incineration; 

• 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. 


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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 acute 

toxicity, reproductive toxicity, 

developmental toxicity, specific target 

organ toxicity, toxicokinetics, 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. 

PMN Number (Proposed CFR Citation): 

P–22–175 (40 CFR 721.12065) 

Chemical Name: Modified 

Silsesquioxane, alkoxy-terminated 

(generic). 

CASRN: Not available. 

Effective Date of TSCA Order: January 

30, 2024. 

Basis for TSCA Order: The PMN states 

that the use will be as a curable binder 

resin for composite stone articles 

(engineered stone). Based on 

comparison to analogous alkoxysilanes 

and other analogous chemical 

substances, EPA has identified concerns 

for lung toxicity. Based on the reactivity 

of the PMN substance and the low 

molecular weight fraction content, EPA 

has also identified concerns for 

irritation to the skin, eyes, and 

respiratory tract. Based on comparison 

with analogous chemical substances, 

EPA has also identified concerns for 

hematological effects (i.e., increased 

neutrophils, eosinophils, lymphocytes) 

associated with lung toxicity. Based on 

comparison to analogous alkoxysilanes, 

EPA predicts toxicity to aquatic 

organisms may occur at concentrations 

that exceed 7 ppb. The Order was issued 

under TSCA sections 5(a)(3)(B)(ii)(I) and 

5(e)(1)(A)(ii)(I), based on a finding that 

in the absence of sufficient information 

to permit a reasoned evaluation, the 

substance may present an unreasonable 

risk of injury to human health and the 

environment. To protect against these 

risks, the Order requires: 

• No domestic manufacture of the 

PMN substance (i.e., import only); 

• Use of the PMN substance only if 

the concentration of the PMN substance 

does not exceed 10% by weight in 

formulation; 

• Use of a NIOSH-certified respirator 

with an APF of at least 10 where there 

is a potential for inhalation exposure; 

• No release of the PMN substance, or 

any waste stream containing the PMN 

substance, in surface water 

concentrations that exceed 7 ppb; 

• 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 skin 

irritation, eye 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. 

PMN Number (Proposed CFR Citation): 

P–23–18 (40 CFR 721.12066) 

Chemical Name: Vegetable oil, 

polymer with pimelin ketone, 

oxymethylene and 

polymethylenepolyphenylene 

isocyanate (generic). 

CASRN: Not applicable. 

Effective Date of TSCA Order: 

February 23, 2024. 

Basis for TSCA Order: The PMN states 

that the use will be as an industrial 

adhesive. Based on the weight of the 

scientific evidence, EPA has identified 

concerns for skin and respiratory 

sensitization and lung toxicity for the 

PMN substance and the low molecular 

weight fraction. Based on test data for 

residuals and comparison to analogous 

chemical substances of the residuals, 

EPA has also identified acute toxicity, 

irritation to the skin, eyes, and 

respiratory tract, skin sensitization, 

respiratory sensitization, neurotoxicity, 

lung effects, systemic effects, 

reproductive and developmental effects, 

genetic toxicity, and carcinogenicity for 

the residuals. 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 manufacture, processing, or use 

of the PMN substance in any manner 

that results in inhalation exposure to the 

PMN substance; 

• No processing for use or use of the 

PMN substance in a consumer product; 

• 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 skin 

irritation, skin sensitization, and 

pulmonary effects 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. 

PMN Number (Proposed CFR Citation): 

P–23–20 (40 CFR 721.12067) 

Chemical Name: Silsesquioxanes, 3- 

mercaptopropyl, polymers with silicic 

acid (H4SiO4) tetra-Et ester, 

[(trimethylsilyl)oxy]-terminated. 

CASRN: 2796383–42–9. 

Effective Date of TSCA Order: 

November 21, 2023. 

Basis for TSCA Order: The PMN states 

that the generic (non-confidential) use 

will be as an additive/intermediate. 

Based on comparison to analogous 

chemical substances and alkoxysilanes, 

EPA has identified concerns for lung 

effects. Based on analogue data for the 

hydrolysis product, EPA has also 

identified concerns for skin 

sensitization and systemic effects. Based 

on comparison to analogous 

alkoxysilanes and thiols, EPA predicts 

toxicity to aquatic organisms may occur 

at concentrations that exceed 3 ppb. The 

Order was issued under TSCA sections 

5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), 

based on a finding that in the absence 

of sufficient information to permit a 

reasoned evaluation, the substance may 


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present an unreasonable risk of injury to 

human health and the environment. To 

protect against these risks, the Order 

requires: 

• Use of the PMN substance only for 

the confidential use listed in the Order; 

• No manufacture, processing, or use 

of the PMN substance in any manner 

that results in inhalation exposure to the 

PMN substance; 

• Use of personal protective 

equipment where there is a potential for 

dermal exposure; 

• No release of the PMN substance, or 

any waste stream containing the PMN 

substance, in surface water 

concentrations that exceed 3 ppb; 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 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. 

PMN Number (Proposed CFR Citation): 

P–23–36 (40 CFR 721.12068). 

Chemical Name: Castor oil, polymer 

with dicyclopentadiene, maleic 

anhydride, 2-methyl-1,3-propanediol, 

3a,4,7,7a-tetrahydro-2-(2-hydroxyethyl)- 

1H-isoindole-1,3(2H)-dione and 

triethylene glycol. 

CASRN: 2794200–69–2. 

Effective Date of TSCA Order: January 

19, 2024. 

Basis for TSCA Order: The PMN states 

that the use will be as a resin used in 

an electrical insulation coating to 

insulate electrical components (motors) 

in automobiles. Based on test data for 

the expected hydrolysis product and an 

analogue of the expected hydrolysis 

product, EPA has identified concerns 

for skin irritation, eye irritation, 

systemic effects, and reproductive/ 

developmental effects. Based on 

comparison to analogous nonionic 

polymers, EPA predicts toxicity to 

aquatic organisms may occur at 

concentrations that exceed 27 ppb. The 

Order was issued under TSCA sections 

5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), 

based on a finding that in the absence 

of sufficient information to permit a 

reasoned evaluation, the substance may 

present an unreasonable risk of injury to 

human health and the environment. To 

protect against these risks, the Order 

requires: 

• No processing for use or use of the 

PMN substance in a consumer product; 

• No manufacture, processing, or use 

of the PMN substance in any manner 

that generates a vapor, mist, dust, or 

aerosol; 

• Use of personal protective 

equipment where there is a potential for 

dermal exposure; 

• No release of the PMN substance, or 

any waste stream containing the PMN 

substance, in surface water 

concentrations that exceed 27 ppb; 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 skin 

irritation, eye irritation, specific target 

organ toxicity, toxicokinetics, 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. 

PMN Numbers (Proposed CFR 

Citations): P–23–37 (40 CFR 721.12069), 

P–23–44 (40 CFR 721.12070), P–23–80 

(40 CFR 721.12071), and P–23–93 (40 

CFR 721.12072) 

Chemical Names: Monoaromatic 

cyclic alkylene sulfonium fluoroalkyl 

sulfonic acid salt (generic) (P–23–37 and 

P–23–44), Aromatic sulfonium tricyclo 

fluoroalkyl sulfonic acid salt (generic) 

(P–23–80), and Aromatic 

dibenzothiophenium fluoroalkyl 

carbopolycycle sulfonic acid salt 

(generic) (P–23–93). 

CASRNs: Not available. 

Effective Date of TSCA Order: 

December 22, 2023. 

Basis for TSCA Order: The PMNs state 

that the generic (non-confidential) use 

of the PMN substances will be as 

photoacid generators (PAGs) for use in 

electronics industry. 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 substance are 

potentially persistent, bioaccumulative, 

and toxic (PBT) chemicals. EPA 

estimates that the PMN substances will 

persist in the environment for more than 

six months and have unknown 

bioaccumulation. Based on comparison 

to analogous chemical compounds, EPA 

has identified concerns for acute 

toxicity, irritation to the skin and 

respiratory tract, neurological effects, 

and systemic effects for the cation of the 

PMN substances, as well as eye 

corrosion for P–23–44, P–23–80, and P– 

23–93. Based on comparison to 

analogous chemical substances, EPA has 

also identified concerns for genetic 

toxicity for the PMN substances, and 

skin sensitization and portal-of-entry 

(respiratory) effects for P–23–93. Based 

on the photoreactivity of the PMN 

substances, EPA has also identified 

concerns for photosensitization. Based 

on comparison to analogous 

compounds, EPA has also identified 

concerns for systemic and reproductive 

effects for the anion of P–23–44 and P– 

23–93. Based on data on a potential 

incineration product, EPA identified 

concerns for local and systemic effects 

via inhalation exposure. Based on a lack 

of scientific data, there is unknown 

toxicity to aquatic organisms. 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 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; 


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• Use of the PMN substances only for 

the confidential uses listed in the Order; 

• No domestic manufacture of the 

PMN substances (i.e., import only); 

• Import of the PMN substances only 

in solution or 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. 

PMN Number (Proposed CFR Citation): 

P–23–64 (40 CFR 721.12073) 

Chemical Name: Alkanediol, 

substituted, polymer with 

diisocyanatoalkane, substituted 

heterocycle-modified (generic). 

CASRN: Not available. 

Effective Date of TSCA Order: 

February 21, 2024. 

Basis for TSCA Order: The PMN states 

that the generic (non-confidential) use 

will be as a component in aerospace 

coatings. Based on comparison to 

analogous chemical substances, EPA has 

identified concerns for pulmonary 

effects, systemic effects, and skin 

sensitization. The Order was issued 

under TSCA sections 5(a)(3)(B)(ii)(I) and 

5(e)(1)(A)(ii)(I), based on a finding that 

in the absence of 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 processing for use or use of the 

PMN substance in consumer products; 

• No manufacture, processing, or use 

of the PMN substance in any manner 

that results in the generation of a vapor, 

mist, dust, or aerosol; 

• 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 

pulmonary effects 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. 

PMN Number (Proposed CFR Citation): 

P–23–72 (40 CFR 721.12074) 

Chemical Name: Halosubstituted 

carbopolycycle, polymer with 

substituted carbomonocycles and 

oxybis[alkanol] (generic). 

CASRN: Not available. 

Effective Date of TSCA Order: 

February 22, 2024. 

Basis for TSCA Order: The PMN states 

that the use will be as a UV resin for 

offset lithographic printing on plastic 

substrates. 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 six months 

and estimates a bioaccumulation factor 

of greater than or equal to 5,000. Based 

on test data for hydrolysis products of 

the low molecular weight fraction of the 

PMN substance, EPA has identified 

concerns for genetic toxicity, 

carcinogenicity, and systemic, 

reproductive, and developmental 

effects. Based on comparison to 

analogous esters, EPA predicts toxicity 

to aquatic organisms may occur at 

concentrations that exceed 0.4 ppb. The 

Order was issued under TSCA sections 

5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), 

based on a finding that in the absence 

of sufficient information to permit a 

reasoned evaluation, the substance may 

present an unreasonable risk of injury to 

human health and the environment. To 

protect against these risks, the Order 

requires: 

• No processing for use or use of the 

PMN substance in a consumer product; 

• No processing for use or use of the 

PMN substance other than in an 

enclosed roll-coating lithographic 

printing machine; 

• No processing for use or use of the 

PMN substance in a final coating 

formulation that exceeds 40% by 

weight; 

• Disposal of the PMN substance only 

by landfill; 

• No release of the PMN substance, or 

any waste stream containing the PMN 

substance, into waters of the United 

States; 

• Use of a NIOSH-certified respirator 

with an APF of at least 10 where there 

is a potential for inhalation exposure; 

• 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 

carcinogenicity, developmental toxicity, 

genetic toxicity, reproductive toxicity, 

specific target organ toxicity, 

toxicokinetics, 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. 

PMN Number (Proposed CFR Citation): 

P–23–94 (40 CFR 721.12075) 

Chemical Name: Polymer of 

benzenedicarboxylic acid, substitutedbenzenedicarboxylic acid, branchedalkyldiol, alkyldiol and triisocyanate 

(generic). 

CASRN: Not available. 

Effective Date of TSCA Order: January 

9, 2024. 

Basis for TSCA Order: The PMN states 

that the use will be as a reactive 

polymer for use in surface pretreatment. Based on test data for the 

feedstock residual, EPA has identified 

concerns for lung effects for the 

residual. Based on OECD QSAR Toolbox 

results and the structural alert for 

diisocyanates, EPA has also identified 


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concerns for dermal and respiratory 

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 

substance may present an unreasonable 

risk of injury to human health. To 

protect against these risks, the Order 

requires: 

• No processing for use or 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 to the 

PMN substance; 

• 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 specific 

target organ toxicity, pulmonary effects, 

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. 

PMN Number (Proposed CFR Citation): 

P–23–172 (40 CFR 721.12076) 

Chemical Name: Sulfonium, 

tricarbocyclic-, alkylcarbomonocyclicpolyfluoro-heteropolycyclic-alkyl 

sulfonate (1:1), polymer with alkylaryl 

and carbomonocyclic alkylalkanoate, diMe 2,2′-(1,2-diazenediyl)bis[2- 

alkylalkanoate]-initiated (generic). 

CASRN: Not available. 

Effective Date of TSCA Order: January 

29, 2024. 

Basis for TSCA Order: The PMN states 

that the generic (non-confidential) use 

of the PMN 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 

six months and estimates unknown 

bioaccumulation. Based on comparison 

to analogous sulfonium compounds, 

EPA has identified concerns for acute 

toxicity, irritation to the skin and 

respiratory tract, eye corrosion, 

neurological effects, and systemic 

effects for the sulfonium cation. Based 

on comparison to analogous chemical 

substances, EPA has also identified 

concerns for genetic toxicity. Based on 

the photoreactivity of the PMN 

substance, EPA has also identified 

concerns for photosensitization. Based 

on a potential incineration product 

(trifluroacetate), EPA has also identified 

concerns for local, neurological, 

developmental and systemic effects via 

inhalation exposure. 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 precautionary statements 

on each label and in the SDS; 

• No modification of the processing 

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 for 

the confidential use listed in the Order; 

• No domestic manufacture of the 

PMN substance (i.e., import only); 

• Import of the PMN substance only 

in solution or 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. 

IV. 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 14094: Modernizing Regulatory 

Review 

This action proposes to establish 

SNURs for new chemical substances 

that were the subject of PMNs. The 

Office of Management and Budget 

(OMB) has exempted these types of 

actions from review under Executive 

Order 12866 (58 FR 51735, October 4, 

1993), as amended by Executive Order 

14094 (88 FR 21879, April 11, 2023). 

B. Paperwork Reduction Act (PRA) 

According to the PRA (44 U.S.C. 3501 

et seq.), an agency may not conduct or 

sponsor, and a person is not required to 

respond to a collection of information 

that requires OMB approval under PRA, 

unless it has been approved by OMB 

and displays a currently valid OMB 

control number. The OMB control 

numbers for EPA’s regulations in title 40 

of the CFR, after appearing in the 

Federal Register, are listed in 40 CFR 

part 9, and included on the related 

collection instrument or form, if 

applicable. 

The information collection 

requirements related to SNURs have 

already been approved by OMB 

pursuant to PRA under OMB control 

number 2070–0038 (EPA ICR No. 1188). 

This action does not impose any burden 

requiring additional OMB approval. If 

an entity were to submit a SNUN to the 

Agency, the annual burden is estimated 

to average between 30 and 170 hours 

per submission. 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. 

EPA always welcomes your feedback 

on the burden estimates. Send any 

comments about the accuracy of the 

burden estimate, and any suggested 

methods for improving the collection 

instruments or instruction or 

minimizing respondent burden, 


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including through the use of automated 

collection techniques. 

C. Regulatory Flexibility Act (RFA) 

I certify that this action will not have 

a significant economic impact on a 

substantial number of small entities 

under the RFA (5 U.S.C. 601 et seq.). 

The 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, 

EPA has concluded that no small or 

large entities presently engage in such 

activities. 

A SNUR requires that any person who 

intends to engage in such activity in the 

future must first notify EPA by 

submitting a SNUN. Although some 

small entities may decide to pursue a 

significant new use in the future, EPA 

cannot presently determine how many, 

if any, there may be. However, EPA’s 

experience to date is that, in response to 

the promulgation of SNURs covering 

over 1,000 chemicals, the Agency 

receives only a small number of notices 

per year. For example, the number of 

SNUNs received was 16 in Federal fiscal 

year (FY) FY2018, five in FY2019, seven 

in FY2020, 13 in FY2021, 11 in FY2022, 

and 15 in FY2023, and only a fraction 

of these submissions were from small 

businesses. 

In addition, the Agency currently 

offers relief to qualifying small 

businesses by reducing the SNUN 

submission fee from $37,000 to $6,480. 

This lower fee reduces the total 

reporting and recordkeeping cost of 

submitting a SNUN to about $14,500 per 

SNUN submission for qualifying small 

firms. Therefore, the potential economic 

impacts of complying with these 

proposed SNURs are not expected to be 

significant or adversely impact a 

substantial number of small entities. In 

a SNUR that published in the Federal 

Register of June 2, 1997 (62 FR 29684) 

(FRL–5597–1), the Agency presented its 

general determination that SNURs are 

not expected to have a significant 

economic impact on a substantial 

number of small entities, which was 

provided to the Chief Counsel for 

Advocacy of the Small Business 

Administration. 

D. Unfunded Mandates Reform Act 

(UMRA) 

This action does not contain an 

unfunded mandate of $100 million or 

more (in 1995 dollars) in any one year 

as described in UMRA, 2 U.S.C. 1531– 

1538, and does not significantly or 

uniquely affect small governments. 

Based on EPA’s experience with 

proposing and finalizing SNURs, State, 

local, and Tribal governments have not 

been impacted by SNURs, and EPA does 

not have any reasons to believe that any 

State, local, or Tribal government will 

be impacted by these SNURs. In 

addition, the estimated costs of this 

action to the private sector do not 

exceed $183 million or more in any one 

year (the 1995 dollars are adjusted to 

2023 dollars for inflation using the GDP 

implicit price deflator). The estimated 

costs for this action are discussed in 

Unit I.D. 

E. Executive Order 13132: Federalism 

This action will not have federalism 

implications as specified in Executive 

Order 13132 (64 FR 43255, August 10, 

1999), because it is not expected to 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. Accordingly, the 

requirements of Executive Order 13132 

do not apply to this action. 

F. Executive Order 13175: Consultation 

and Coordination With Indian Tribal 

Governments 

This action will not have Tribal 

implications as specified in Executive 

Order 13175 (65 FR 67249, November 9, 

2000), because it is not expected to have 

substantial direct effects on Indian 

Tribes, significantly or uniquely affect 

the communities of Indian Tribal 

governments and does not involve or 

impose any requirements that affect 

Indian Tribes. Accordingly, the 

requirements of Executive Order 13175 

do not apply to this action. 

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 it does not concern an 

environmental health or safety risk. 

Since this action does not concern a 

human health risk, EPA’s 2021 Policy 

on Children’s Health also does not 

apply. Although the establishment of 

these SNURs do not address an existing 

children’s environmental health 

concern because the chemical uses 

involved are not ongoing uses, SNURs 

require that persons notify EPA at least 

90 days before commencing 

manufacture (defined by statute to 

include import) or processing of any of 

these chemical substances for an 

activity that is designated as a 

significant new use by this rulemaking. 

This notification allows EPA to assess 

the intended uses to identify potential 

risks and take appropriate actions before 

the activities commence. 

H. Executive Order 13211: Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use 

This action is not a ‘‘significant 

energy action’’ as defined in Executive 

Order 13211 (66 FR 28355, May 22, 

2001), because it is not likely to have a 

significant adverse effect on the supply, 

distribution, or use of energy. 

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 and Executive 

Order 14096: Revitalizing Our Nation’s 

Commitment to Environmental Justice 

for All 

EPA believes that this type of action 

does not concern human health or 

environmental conditions and therefore 

cannot be evaluated with respect to the 

potentially disproportionate and 

adverse effects on communities with 

environmental justice concerns in 

accordance with Executive Orders 

12898 (59 FR 7629, February 16, 1994) 

and 14096 (88 FR 25251, April 26, 

2023). Although this action does not 

concern human health or environmental 

conditions, the premanufacture 

notifications required by these SNURs 

will allow EPA to assess the intended 

uses to identify potential 

disproportionate risks and take 

appropriate actions before the activities 

commence. 

List of Subjects in 40 CFR part 721 

Environmental protection, Chemicals, 

Hazardous substances, Reporting and 

recordkeeping requirements. 

Kevin DeBell, 

Acting Director, Office of Pollution Prevention 

and Toxics. 

Therefore, for the reasons stated in the 

preamble, EPA proposes to amend 40 

CFR chapter I as follows: 

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). 


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■ 2. Add §§ 721.12043 through 

721.12076 to Subpart E to read as 

follows: 

Subpart E—Significant New Uses for 

Specific Chemical Substances 

Sec. 

* * * * * 

721.12043 Heptane, 2-methoxy-2-methyl-. 

721.12044 Benzenesulfonic acid, alkyl-, 

compd. with 1,1′-iminobis[2-propanol] 

(1:1) (generic). 

721.12045 Sugars, polymer with 

alkanetriamine (generic). 

721.12046 Isooctadecanamide, N,N-bis(2- 

ethylhexyl)-. 

721.12047 2-Butanone, oxime, reaction 

products with trimethoxymethylsilane. 

721.12048 2,6-Bis(dialkyl)-4-[2-(1-alkyl4(1H)-pyridinylidene)alkylidene]-2,5- 

cycloalkyladien-1-one (generic). 

721.12049 Fatty acids, soya, reaction 

products with ammonia-ethanolamine 

reaction by-products. 

721.12050 1,5-Pentanediamine, 2-methyl-, 

hydrochloride (1:2). 

721.12051 1,5-Pentanediamine, 2-methyl-, 

hydrochloride (1:1). 

721.12052 Formic acid, compd. with 2- 

methyl-1,5- pentanediamine (2:1). 

721.12053 Formic acid, compd. with 2- 

methyl-1,5-pentanediamine (1:1). 

721.12054 Alkadiene, homopolymer, 

hydroxy-terminated, bis[N-[2-[(1-oxo-2- 

propen-1-yl)oxylethyl]carbamates] 

(generic). 

721.12055 Oxirane, 2-(chloromethyl)-, 

homopolymer, ether with dialkylalkanediol (2:1) (generic). 

721.12056 Aryl, polymer with 

formaldehyde, glycidyl ether, reaction 

products with amino alkyl-alkane 

diamine, cyclohexanediamine and 

alkylene (alkylcyclohexanamine) 

(generic). 

721.12057 Alkene, alkoxy-, polymer with 

alkoxyalkene (generic). 

721.12058 Methanesulfonamide, 1,1,1- 

trifluoro-N-[(trifluoromethyl)sulfonyl]-, 

sodium salt (1:1). 

721.12059 1H-Isoindole-1,3(2H)-dione, 

3a,4,7,7a-tetrahydro-2-(2-hydroxyethyl). 

721.12060 Oxirane, 2-methyl-, polymer 

with oxirane, mono-isoalkyl ethers, 

phosphates, salt (generic). 

721.12061 Poly(oxy-1,2-ethanediyl), 

.alpha.-(2-aminoethyl)-.omega.-(2- 

aminoethoxy)- and Poly(oxy-1,2- 

ethanediyl), .alpha.,.alpha.′,-(iminodi2,1- ethanediyl)bis[.omega.-(2- 

aminoethoxy)-. 

721.12062 Alkenoic acid, alkyl, 

carbopolycyclic alkyl ester, polymer 

with trihalo (trihaloalkyl) alkyl alkyl 

alkenoate (generic). 

721.12063 Polychloroalkene (generic). 

721.12064 Alkanoic acid, trialkyl-, diester 

with carbomonocycle 

bis(alkyleneoxy)]bis[alkanediol] 

(generic). 

721.12065 Modified Silsesquioxane, 

alkoxy-terminated (generic). 

721.12066 Vegetable oil, polymer with 

pimelin ketone, oxymethylene and 

polymethylenepolyphenylene isocyanate 

(generic). 

721.12067 Silsesquioxanes, 3- 

mercaptopropyl, polymers with silicic 

acid (H4SiO4) tetra-Et ester, 

[(trimethylsilyl)oxy]-terminated. 

721.12068 Castor oil, polymer with 

dicyclopentadiene, maleic anhydride, 2- 

methyl-1,3-propanediol, 3a,4,7,7atetrahydro-2-(2-hydroxyethyl)-1Hisoindole-1,3(2H)-dione and triethylene 

glycol. 

721.12069 Monoaromatic cyclic alkylene 

sulfonium fluoroalkyl sulfonic acid salt 

(generic). 

721.12070 Monoaromatic cyclic alkylene 

sulfonium fluoroalkyl sulfonic acid salt 

(generic). 

721.12071 Aromatic sulfonium tricyclo 

fluoroalkyl sulfonic acid salt (generic). 

721.12072 Aromatic dibenzothiophenium 

fluoroalkyl carbopolycycle sulfonic acid 

salt (generic). 

721.12073 Alkanediol, substituted, polymer 

with diisocyanatoalkane, substituted 

heterocycle-modified (generic). 

721.12074 Halosubstituted carbopolycycle, 

polymer with substituted 

carbomonocycles and oxybis[alkanol] 

(generic). 

721.12075 Polymer of benzenedicarboxylic 

acid, substituted-benzenedicarboxylic 

acid, branched-alkyldiol, alkyldiol and 

triisocyanate (generic). 

721.12076 Sulfonium, tricarbocyclic-, 

alkylcarbomonocyclic-polyfluoroheteropolycyclic-alkyl sulfonate (1:1), 

polymer with alkylaryl and 

carbomonocyclic alkylalkanoate, di-Me 

2,2′-(1,2-diazenediyl)bis[2- 

alkylalkanoate]-initiated (generic). 

* * * * * 

§ 721.12043 Heptane, 2-methoxy-2-methyl-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

as Heptane, 2-methoxy-2-methyl- (PMN 

P–18–127; CASRN 76589–16–7) 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), (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), (3), and (5). For 

purposes of § 721.72(g)(1), this 

substance may cause: skin sensitization 

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 manufacture the substance 

unless by import into the United States 

in a solution of no greater than 5% by 

weight (i.e., no domestic manufacture). 

It is a significant new use to process the 

substance unless in a solution of no 

greater than 5% by weight of the 

substance. It is a significant new use to 

process for use or use the substance in 

consumer products unless the 

concentration of the substance is less 

than 1% by weight. 

(iv) Release to water. Requirements as 

specified in § 721.90(a)(4), (b)(4), and 

(c)(4), where N=210. 

(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. 

§ 721.12044 Benzenesulfonic acid, alkyl-, 

compd. with 1,1′-iminobis[2-propanol] (1:1) 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as benzenesulfonic acid, 

alkyl-, compd. with 1,1′-iminobis[2- 

propanol] (1:1) (PMN P–18–325) 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) and (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), and (g)(1), (3) and (5). For 


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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 § 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). It is a 

significant new use to manufacture, 

process, or use the substance in any 

manner that results in inhalation 

exposure to the substance. It is a 

significant new use to process for use or 

use the substance other than as an 

industrial cross-linking catalyst. 

(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. 

§ 721.12045 Sugars, polymer with 

alkanetriamine (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as sugars, polymer with 

alkanetriamine (PMN P–20–14) 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 

cured. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1) and (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), (3), and (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: 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(o). 

(iv) Release to water. Requirements as 

specified in § 721.90(a)(4), (b)(4), and 

(c)(4), where N=191. 

(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. 

§ 721.12046 Isooctadecanamide, N,Nbis(2-ethylhexyl)-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

as isooctadecanamide, N,N-bis(2- 

ethylhexyl)- (PMN P–21–86; CASRN 

1616494–50–8) 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 entrained 

in a polymer. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1) and (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 (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. It is a significant 

new use to process the substance for use 

in a consumer product where the 

concentration of the substance in the 

consumer product formulation exceeds 

the confidential percentage listed in the 

Order. It is a significant new use to use 

the substance in a consumer product 

where the concentration of the 

substance exceeds the confidential 

percentage listed in the Order. 

(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. 

§ 721.12047 2-Butanone, oxime, reaction 

products with trimethoxymethylsilane. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

as 2-butanone, oxime, reaction products 

with trimethoxymethylsilane (PMN P– 

21–164; CASRN 2639393–45–4) 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 or 

cured. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

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

When determining which persons are 

reasonably likely to be exposed as 

required for § 721.63(a)(1) and (4), 

engineering control measures (e.g., 

enclosure or confinement of the 

operation, general and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent 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) 


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

purposes of § 721.72(g)(1), this 

substance may cause: acute toxicity, 

carcinogenicity, serious eye damage, 

reproductive toxicity, skin irritation, 

skin sensitization, 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 load or unload the substance 

for manufacture, processing, or use in 

any manner unless under a gas (e.g. 

nitrogen) blanket. It is a significant new 

use to use the substance unless at 4% 

or less by weight in formulation. It is a 

significant new use to apply the 

substance for use unless by roll, brush, 

or dip coating. 

(iv) Disposal. Requirements as 

specified in § 721.85(a)(1), (b)(1), and 

(c)(1). 

(v) 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 (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. 

§ 721.12048 2,6-Bis(dialkyl)-4-[2-(1-alkyl4(1H)-pyridinylidene)alkylidene]-2,5- 

cycloalkyladien-1-one (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as 2,6-bis(dialkyl)-4-[2-(1- 

alkyl-4(1H)-pyridinylidene)alkylidene]- 

2,5-cycloalkyladien-1-one (generic) 

(PMN P–21–170) 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), (3) through (6), and (c). 

When determining which persons are 

reasonably likely to be exposed as 

required for § 721.63(a)(1) and (4), 

engineering control measures (e.g., 

enclosure or confinement of the 

operation, general and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent 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. 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

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

purposes of § 721.72(g)(1), this 

substance may cause: acute toxicity, 

skin irritation, eye irritation, skin 

sensitization, genetic toxicity, 

carcinogenicity, 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(k), (t). It is a 

significant new use to manufacture the 

substance in excess of an annual volume 

of 10 kg. It is a significant new use to 

process for use or use the substance 

other than as a color indicator for frying 

oil breakdown. It is a significant new 

use to manufacture, process, or use the 

substance in any manner that results in 

the release of the substance to air except 

with the use of a HEPA filtration 

system. 

(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. 

§ 721.12049 Fatty acids, soya, reaction 

products with ammonia-ethanolamine 

reaction by-products. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

as fatty acids, soya, reaction products 

with ammonia-ethanolamine reaction 

by-products (PMN P–21–184; CASRN 

2378512–59–3) 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), (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), (3), and (5). For 

purposes of § 721.72(g)(1), this 

substance may cause: acute toxicity, 

skin corrosion, skin irritation, serious 

eye damage, eye irritation, skin 

sensitization, 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(o), and (y)(1) and 

(2). It is a significant new use to 

manufacture, process, or use the 

substance in any manner that results in 

the generation of vapor, mist, aerosol, or 

dust. 

(iv) Release to water. Requirements as 

specified in § 721.90(a)(4), (b)(4), and 

(c)(4), where N=2. 

(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. 

§ 721.12050 1,5-Pentanediamine, 

2-methyl-, hydrochloride (1:2). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

as 1,5-pentanediamine, 2-methyl-, 

hydrochloride (1:2) (PMN P–22–3; 

CASRN 34813–63–3) 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), (3), (b), and (c). When 

determining which persons are 


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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), (3), and (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: acute toxicity, 

skin irritation, and eye irritation. 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 to the substance. 

(iv) Release to water. Requirements as 

specified in § 721.90(a)(4), (b)(4), and 

(c)(4), where N=570 of P–22–3, P–22–4, 

P–22–5, and P–22–6 combined. 

(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. 

§ 721.12051 1,5-Pentanediamine, 

2-methyl-, hydrochloride (1:1). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

as 1,5-pentanediamine, 2-methyl-, 

hydrochloride (1:1) (PMN P–22–4; 

CASRN 1840915–04–9) 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), (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), (3), and (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: acute toxicity, 

skin irritation, eye irritation, serious eye 

damage, skin corrosion, 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(o). It is a 

significant new use to manufacture, 

process, or use the substance in any 

manner that results in inhalation 

exposure to the substance. 

(iv) Release to water. Requirements as 

specified in § 721.90(a)(4), (b)(4), and 

(c)(4), where N=570 of P–22–3, P–22–4, 

P–22–5, and P–22–6 combined. 

(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. 

§ 721.12052 Formic acid, compd. with 2- 

methyl-1,5- pentanediamine (2:1). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

as formic acid, compd. with 2-methyl1,5- pentanediamine (2:1) (PMN P–22– 

5; CASRN 1836131–73–7) 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) and (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), (3), and (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: acute toxicity, 

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. 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 to the substance. 

(iv) Release to water. Requirements as 

specified in § 721.90(a)(4), (b)(4), and 

(c)(4), where N=570 of P–22–3, P–22–4, 

P–22–5, and P–22–6 combined. 

(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. 

§ 721.12053 Formic acid, compd. with 2- 

methyl-1,5-pentanediamine (1:1). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

as formic acid, compd. with 2-methyl1,5-pentanediamine (1:1) (PMN P–22–6; 

CASRN 1836131–75–9) 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) and (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 


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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), (3), and (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: acute toxicity, 

skin corrosion, skin irritation, serious 

eye damage, 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. 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 to the substance. 

(iv) Release to water. Requirements as 

specified in § 721.90(a)(4), (b)(4), and 

(c)(4), where N=570 of P–22–3, P–22–4, 

P–22–5, and P–22–6 combined. 

(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. 

§ 721.12054 Alkadiene, homopolymer, 

hydroxy-terminated, bis[N-[2-[(1-oxo-2- 

propen-1- yl)oxylethyl]carbamates] 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as alkadiene, homopolymer, 

hydroxy-terminated, bis[N-[2-[(1-oxo-2- 

propen-1-yl)oxylethyl]carbamates] 

(PMN P–22–11) 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), (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 (5). For 

purposes of § 721.72(g)(1), this 

substance may cause: skin sensitization, 

respiratory sensitization, reproductive 

toxicity, and 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 manufacture, 

process, or use the substance in any 

manner that results in inhalation 

exposure to the substance. 

(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. 

§ 721.12055 Oxirane, 2-(chloromethyl)-, 

homopolymer, ether with dialkyl-alkanediol 

(2:1) (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as oxirane, 2-(chloromethyl)- 

, homopolymer, ether with dialkylalkanediol (2:1) (PMN P–22–25) 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), (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 

0.1%. 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

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

of § 721.72(e), the concentration is set at 

0.1%. For purposes of § 721.72(g)(1), 

this substance may cause: acute toxicity, 

skin irritation, eye irritation, genetic 

toxicity, carcinogenicity, and 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(g), (t), (y)(1), and 

(2). It is a significant new use to 

manufacture, process, or use the 

substance in any manner that generates 

a vapor, mist, aerosol, or dust. 

(iv) Disposal. It is a significant new 

use to dispose of the substance, or waste 

streams containing the substance, other 

than by hazardous waste incineration. 

(v) 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 (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. 

§ 721.12056 Aryl, polymer with 

formaldehyde, glycidyl ether, reaction 

products with amino alkyl-alkane diamine, 

cyclohexanediamine and alkylene 

(alkylcyclohexanamine) (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as aryl, polymer with 

formaldehyde, glycidyl ether, reaction 

products with amino alkyl-alkane 

diamine, cyclohexanediamine and 

alkylene (alkylcyclohexanamine) (PMN 

P–22–49) 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 cured. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

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

When determining which persons are 

reasonably likely to be exposed as 

required for § 721.63(a)(1) and (4), 

engineering control measures (e.g., 


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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. 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

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

purposes of § 721.72(g)(1), this 

substance may cause: acute toxicity, 

skin irritation, eye irritation, skin 

corrosion, serious eye damage, 

respiratory sensitization, skin 

sensitization, genetic toxicity, 

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(o). 

(iv) Release to water. Requirements as 

specified in § 721.90(a)(4), (b)(4), and 

(c)(4), where N=2. 

(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. 

§ 721.12057 Alkene, alkoxy-, polymer with 

alkoxyalkene (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as alkene, alkoxy-, polymer 

with alkoxyalkene (PMN P–22–50) 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) and (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), (3), and (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. Requirements as 

specified in § 721.80(k) and (o). It is a 

significant new use to manufacture, 

process, or use the substance in any 

manner that results in inhalation 

exposure to the substance. 

(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. 

§ 721.12058 Methanesulfonamide, 1,1,1- 

trifluoro-N-[(trifluoromethyl)sulfonyl]-, 

sodium salt (1:1). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

as Methanesulfonamide, 1,1,1-trifluoroN-[(trifluoromethyl)sulfonyl]-, sodium 

salt (1:1) (PMN P–22–58; CASRN 

91742–21–1) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. The requirements of this 

section do not apply to quantities of the 

substance after they have been 

incorporated into an article. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

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

(c). When determining which persons 

are reasonably likely to be exposed as 

required for § 721.63(a)(1) and (4), 

engineering control measures (e.g., 

enclosure or confinement of the 

operation, general and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent 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%. 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (f), (g)(1), (3), and (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: acute toxicity, 

serious eye damage, skin irritation, 

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(b), (k), (v)(2), and 

(y)(1) and (2). It is a significant new use 

to process the substance in a manner 

that generates a vapor, mist, aerosol, or 

dust that results in inhalation to 

workers. 

(iv) Release to water. Requirements as 

specified in § 721.90(a)(4), (b)(4), and 

(c)(4), where N=100. 

(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. 

§ 721.12059 1H-Isoindole-1,3(2H)-dione, 

3a,4,7,7a-tetrahydro-2-(2-hydroxyethyl)-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

as 1H-Isoindole-1,3(2H)-dione, 

3a,4,7,7a-tetrahydro-2-(2-hydroxyethyl)- 

(PMN P–22–75; CASRN 15458–48–7) 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 

cured. 

(2) The significant new uses are: 


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(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (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), (3), and (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: acute toxicity, 

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. Requirements as 

specified in § 721.80(f), (k), and (t). It is 

a significant new use to manufacture the 

substance in excess of an annual volume 

of 3,000 kg. It is a significant new use 

to use the substance other than as a 

monomer used to produce an 

unsaturated polyester resin. 

(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. 

§ 721.12060 Oxirane, 2-methyl-, polymer 

with oxirane, mono-isoalkyl ethers, 

phosphates, salt (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as oxirane, 2-methyl-, 

polymer with oxirane, mono-isoalkyl 

ethers, phosphates, salt (PMN P–22–78) 

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) and (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), (3), and (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 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(k). It is a 

significant new use to manufacture or 

process the substance in a manner that 

generates a vapor, mist, aerosol, or dust. 

It is a significant new use to process for 

use or use the substance other than as 

a dispersing agent for pesticide 

formulations. 

(iv) Release to water. Requirements as 

specified in § 721.90(a)(4), (b)(4), and 

(c)(4), where N=23. 

(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. 

§ 721.12061 Poly(oxy-1,2-ethanediyl), 

.alpha.-(2-aminoethyl)-.omega.-(2- 

aminoethoxy)- and Poly(oxy-1,2-ethanediyl), 

.alpha.,.alpha.′,-(iminodi-2,1- 

ethanediyl)bis[.omega.-(2-aminoethoxy)-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

as poly(oxy-1,2-ethanediyl), .alpha.-(2- 

aminoethyl)-.omega.-(2-aminoethoxy)- 

and poly(oxy-1,2-ethanediyl), 

.alpha.,.alpha.′,-(iminodi-2,1- 

ethanediyl)bis[.omega.-(2-aminoethoxy)- 

(PMN P–22–80; CAS Nos. 24991–53–5 

and 90350–34–8) 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 destroyed. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (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), (3), and (5). For 

purposes of § 721.72(g)(1), this 

substance may cause: acute toxicity, 

skin corrosion, serious eye damage, and 

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 manufacture, process, or use 

the substance in any manner that results 

in inhalation exposure to the substance. 

(iv) Release to water. Requirements as 

specified in § 721.90(a)(4), (b)(4), and 

(c)(4), where N=0.7. 

(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. 

§ 721.12062 Alkenoic acid, alkyl, 

carbopolycyclic alkyl ester, polymer with 

trihalo (trihaloalkyl) alkyl alkyl alkenoate 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as alkenoic acid, alkyl, 

carbopolycyclic alkyl ester, polymer 

with trihalo (trihaloalkyl) alkyl alkyl 

alkenoate (PMN P–22–82) is subject to 

reporting under this section for the 

significant new uses described in 


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paragraph (a)(2) of this section. The 

requirements of this section do not 

apply to quantities of the substance after 

they have been entrained in dried 

photoresist. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (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 (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: reproductive 

toxicity and 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), (k), (v)(1), (2) 

and (4), (w)(1), (2) and (4), and (x)(1), (2) 

and (4). It is a significant new use to 

manufacture the substance other than by 

import into the United States (i.e., no 

domestic manufacture) in a liquid 

formulation. 

(iv) Disposal. Requirements as 

specified in § 721.85(a)(1), (b)(1), and 

(c)(1). 

(v) 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 (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. 

§ 721.12063 Polychloroalkene (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as polychloroalkene (PMN 

P–22–121) 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. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

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

When determining which persons are 

reasonably likely to be exposed as 

required for § 721.63(a)(1) and (4), 

engineering control measures (e.g., 

enclosure or confinement of the 

operation, general and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent 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), (3), and (5). For 

purposes of § 721.72(g)(1), this 

substance may cause: acute toxicity, 

skin irritation, serious eye damage, skin 

sensitization, genetic toxicity, 

carcinogenicity, 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) and (k). It is a 

significant new use to process, use, 

load, or unload the substance unless 

under a gas (e.g., nitrogen) blanket or in 

a closed system except that sampling 

may occur outside the closed system 

resulting in exposures. 

(iv) Release to water. Requirements as 

specified in § 721.90(a)(4), (b)(4), and 

(c)(4), where N=0.15. 

(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. 

§ 721.12064 Alkanoic acid, trialkyl-, diester 

with carbomonocycle 

bis(alkyleneoxy)]bis[alkanediol] (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as alkanoic acid, trialkyl-, 

diester with carbomonocycle 

bis(alkyleneoxy)]bis[alkanediol] (PMN 

P–22–145) 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), (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), (3), and (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: acute toxicity, 

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(o). It is a 

significant new use to use the substance 

in any manner that may generate a 

spray, mist, vapor, or aerosol containing 

the substance unless the concentration 

of the substance is less than 5.7% by 

weight. 

(iv) Disposal. Requirements as 

specified in § 721.85(a)(1), (b)(1), and 

(c)(1). 

(v) 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 (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. 

§ 721.12065 Modified Silsesquioxane, 

alkoxy-terminated (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as modified silsesquioxane, 

alkoxy-terminated (PMN P–22–175) 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), (3) through (6), (b), and 

(c). When determining which persons 

are reasonably likely to be exposed as 

required for § 721.63(a)(1) and (4), 

engineering control measures (e.g., 

enclosure or confinement of the 

operation, general and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent 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), (3), and (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. Requirements as 

specified in § 721.80(f). It is a significant 

new use to use the substance unless the 

concentration of the substance does not 

exceed 10% by weight in formulation. 

(iv) Release to water. Requirements as 

specified in § 721.90(a)(4), (b)(4), and 

(c)(4), where N=7. 

(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. 

§ 721.12066 Vegetable oil, polymer with 

pimelin ketone, oxymethylene and 

polymethylenepolyphenylene isocyanate 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as vegetable oil, polymer 

with pimelin ketone, oxymethylene and 

polymethylenepolyphenylene 

isocyanate (PMN P–23–18) 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 

cured. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1) and (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 (5). For 

purposes of § 721.72(g)(1), this 

substance may cause: acute toxicity, 

skin irritation, eye irritation, respiratory 

sensitization, skin sensitization, genetic 

toxicity, carcinogenicity, reproductive 

toxicity, and 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 manufacture, 

process, or use the substance in any 

manner that results in inhalation 

exposure to the substance. 

(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. 

§ 721.12067 Silsesquioxanes, 3- 

mercaptopropyl, polymers with silicic acid 

(H4SiO4) tetra-Et ester, [(trimethylsilyl)oxy]- 

terminated. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

as silsesquioxanes, 3-mercaptopropyl, 

polymers with silicic acid (H4SiO4) 

tetra-Et ester, [(trimethylsilyl)oxy]- 

terminated (PMN P–23–20; CASRN 

2796383–42–9) 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 cured. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (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), (3), and (5). For 

purposes of § 721.72(g)(1), this 

substance may cause: skin sensitization 

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(k). It is a 

significant new use to manufacture, 

process, or use the substance in any 

manner that results inhalation exposure. 

(iv) Release to water. Requirements as 

specified in § 721.90(a)(4), (b)(4), and 

(c)(4), where N=3. 

(b) Specific requirements. The 

provisions of Subpart A of this part 

apply to this section except as modified 

by this paragraph (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. 


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§ 721.12068 Castor oil, polymer with 

dicyclopentadiene, maleic anhydride, 2- 

methyl-1,3-propanediol, 3a,4,7,7atetrahydro-2-(2-hydroxyethyl)-1H-isoindole1,3(2H)-dione and triethylene glycol. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

as castor oil, polymer with 

dicyclopentadiene, maleic anhydride, 2- 

methyl-1,3-propanediol, 3a,4,7,7atetrahydro-2-(2-hydroxyethyl)-1Hisoindole-1,3(2H)-dione and triethylene 

glycol (PMN P–23–36; CASRN 

2794200–69–2) 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 or cured. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (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), (3), and (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. Requirements as 

specified in § 721.80(o), (y)(1), and (2). 

It is a significant new use to 

manufacture or process the substance in 

a manner that generates a vapor, mist, 

aerosol, or dust. 

(iv) Release to water. Requirements as 

specified in § 721.90(a)(4), (b)(4), and 

(c)(4), where N=27. 

(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. 

§ 721.12069 Monoaromatic cyclic alkylene 

sulfonium fluoroalkyl sulfonic acid salt 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as monoaromatic cyclic 

alkylene sulfonium fluoroalkyl sulfonic 

acid salt (PMN P–23–37) 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), (2)(i) and (iii), (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), (2)(i) through (iii), 

(v), (3)(i) and (ii), and (5). For purposes 

of § 721.72(g)(1), this substance may 

cause: acute toxicity, skin irritation, 

skin sensitization, genetic toxicity, and 

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), (k), and (t). It is 

a significant new use to import the 

substance other than in solution, or in 

sealed containers weighing 5 kilograms 

or less. It is a significant new use to 

modify the processing or use of 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. 

§ 721.12070 Monoaromatic cyclic alkylene 

sulfonium fluoroalkyl sulfonic acid salt 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as monoaromatic cyclic 

alkylene sulfonium fluoroalkyl sulfonic 

acid salt (PMN P–23–44) 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), (2)(i) and (iii), (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), (2)(i) through (iii), 

(v), (3)(i) and (ii), and (5). For purposes 

of § 721.72(g)(1), this substance may 

cause: acute toxicity, skin irritation, 

serious eye damage, reproductive 

toxicity, skin sensitization, genetic 

toxicity, and 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), (k), and (t). It is 

a significant new use to import the 

substance other than in solution, or in 

sealed containers weighing 5 kilograms 

or less. It is a significant new use to 

modify the processing or use of the 

substance in any way that generates 


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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. 

§ 721.12071 Aromatic sulfonium tricyclo 

fluoroalkyl sulfonic acid salt (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as aromatic sulfonium 

tricyclo fluoroalkyl sulfonic acid salt 

(PMN P–23–80) 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), (2)(i) and (iii), (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), (2)(i) through (iii), 

(v), (3)(i) and (ii), and (5). For purposes 

of § 721.72(g)(1), this substance may 

cause: acute toxicity, skin irritation, 

serious eye damage, skin sensitization, 

genetic toxicity, and 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), (k), and (t). It is 

a significant new use to import the 

substance other than in solution, or in 

sealed containers weighing 5 kilograms 

or less. It is a significant new use to 

modify the processing or use of 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. 

§ 721.12072 Aromatic dibenzothiophenium 

fluoroalkyl carbopolycycle sulfonic acid salt 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as aromatic 

dibenzothiophenium fluoroalkyl 

carbopolycycle sulfonic acid salt (PMN 

P–23–93) 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), (2)(i) and (iii), (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), (2)(i) through (iii), 

(v), (3)(i) and (ii), and (5). For purposes 

of § 721.72(g)(1), this substance may 

cause: acute toxicity, skin irritation, 

serious eye damage, reproductive 

toxicity, skin sensitization, genetic 

toxicity, and 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), (k), and (t). It is 

a significant new use to import the 

substance other than in solution, or in 

sealed containers weighing 5 kilograms 

or less. It is a significant new use to 

modify the processing or use of 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. 

§ 721.12073 Alkanediol, substituted, 

polymer with diisocyanatoalkane, 

substituted heterocycle-modified (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as alkanediol, substituted, 

polymer with diisocyanatoalkane, 

substituted heterocycle-modified (PMN 

P–23–64) 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 cured. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (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 (5). For 

purposes of § 721.72(g)(1), this 

substance may cause: skin sensitization 

and specific target organ toxicity. 

Alternative hazard and warning 

statements that meet the criteria of the 

Globally Harmonized System and OSHA 


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Hazard Communication Standard may 

be used. 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(o), and (y)(1) and 

(2). It is a significant new use to 

manufacture or process the substance in 

a manner that generates a vapor, mist, 

aerosol, or dust. 

(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. 

§ 721.12074 Halosubstituted 

carbopolycycle, polymer with substituted 

carbomonocycles and oxybis[alkanol] 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as halosubstituted 

carbopolycycle, polymer with 

substituted carbomonocycles and 

oxybis[alkanol] (PMN P–23–72) 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 

cured. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

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

(c). When determining which persons 

are reasonably likely to be exposed as 

required for § 721.63(a)(1) and (4), 

engineering control measures (e.g., 

enclosure or confinement of the 

operation, general and local ventilation) 

or administrative control measures (e.g., 

workplace policies and procedures) 

shall be considered and implemented to 

prevent 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 

0.1%. 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

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

purposes of § 721.72(e), the 

concentration is set at 0.1%. For 

purposes of § 721.72(g)(1), this 

substance may cause: genetic toxicity, 

carcinogenicity, 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(o). It is a 

significant new use to process for use or 

use the substance other than in an 

enclosed roll-coating lithographic 

printing machine. It is a significant new 

use to process for use or use the 

substance to a final formulation for 

coating application that exceeds 40% by 

weight. 

(iv) Disposal. Requirements as 

specified in § 721.85(a)(2), (b)(2), and 

(c)(2). 

(v) 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 (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. 

§ 721.12075 Polymer of 

benzenedicarboxylic acid, substitutedbenzenedicarboxylic acid, branchedalkyldiol, alkyldiol and triisocyanate 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as polymer of 

benzenedicarboxylic acid, substitutedbenzenedicarboxylic acid, branchedalkyldiol, alkyldiol and triisocyanate 

(PMN P–23–94) 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 cured. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (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 (5). For 

purposes of § 721.72(g)(1), this 

substance may cause: skin sensitization, 

respiratory sensitization, and 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 manufacture, 

process, or use the substance in any 

manner that results 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. 

§ 721.12076 Sulfonium, tricarbocyclic-, 

alkylcarbomonocyclic-polyfluoroheteropolycyclic-alkyl sulfonate (1:1), 

polymer with alkylaryl and carbomonocyclic 

alkylalkanoate, di-Me 2,2′-(1,2- 

diazenediyl)bis[2-alkylalkanoate]-initiated 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as sulfonium, tricarbocyclic-, 

alkylcarbomonocyclic-polyfluoroheteropolycyclic-alkyl sulfonate (1:1), 

polymer with alkylaryl and 

carbomonocyclic alkylalkanoate, di-Me 

2,2′-(1,2-diazenediyl)bis[2- 

alkylalkanoate]-initiated (PMN P–23– 

172) 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), (2)(i) and (iii), (3), and (c). 

When determining which persons are 

reasonably likely to be exposed as 


ddrumheller on DSK120RN23PROD with PROPOSALS1
102074 Federal Register / Vol. 89, No. 242 / Tuesday, December 17, 2024 / Proposed Rules 

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), (2)(i) through (iii), 

(v), (3)(i) and (ii), and (5). For purposes 

of § 721.72(g)(1), this substance may 

cause: acute toxicity, skin irritation, 

serious eye damage, skin sensitization, 

genetic toxicity, reproductive toxicity, 

and 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), (k), and (t). It is 

a significant new use to import the 

substance other than in solution, or in 

sealed containers weighing 5 kilograms 

or less. It is a significant new use to 

modify the processing of 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. 

[FR Doc. 2024–29275 Filed 12–16–24; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF THE INTERIOR 

Fish and Wildlife Service 

50 CFR Part 17 

[Docket No. FWS–R7–ES–2024–0117; 

FXES1111090FEDR–256–FF09E21000] 

RIN 1018–BI15 

Endangered and Threatened Wildlife 

and Plants; Endangered Species 

Status for Suckley’s Cuckoo Bumble 

Bee 

AGENCY: Fish and Wildlife Service, 

Interior. 

ACTION: Proposed rule. 

SUMMARY: We, the U.S. Fish and 

Wildlife Service (Service), propose to 

list the Suckley’s cuckoo bumble bee 

(Bombus suckleyi), an invertebrate 

species from North America, as an 

endangered species under the 

Endangered Species Act of 1973, as 

amended (Act). This determination also 

serves as our 12-month finding on a 

petition to list the Suckley’s cuckoo 

bumble bee. After a review of the best 

available scientific and commercial 

information, we find that listing the 

species is warranted. Accordingly, we 

propose to list the species as an 

endangered species under the Act. If we 

finalize this rule as proposed, it would 

add this species to the List of 

Endangered and Threatened Wildlife 

and extend the Act’s protections to the 

species. Due to the current lack of data 

sufficient to perform required analyses, 

we conclude that the designation of 

critical habitat for the species is not 

determinable at this time. 

DATES: We will accept comments 

received or postmarked on or before 

February 18, 2025. Comments submitted 

electronically using the Federal 

eRulemaking Portal (see ADDRESSES, 

below) must be received by 11:59 p.m. 

eastern time on the closing date. We 

must receive requests for a public 

hearing, in writing, at the address 

shown in FOR FURTHER INFORMATION

CONTACT by January 31, 2025. 

ADDRESSES: You may submit comments 

by one of the following methods: 

(1) Electronically: Go to the Federal 

eRulemaking Portal: 

https://www.regulations.gov. In the 

Search box, enter FWS–R7–ES–2024– 

0117, which is the docket number for 

this rulemaking. Then, click on the 

Search button. On the resulting page, in 

the panel on the left side of the screen, 

under the Document Type heading, 

check the Proposed Rule box to locate 

this document. You may submit a 

comment by clicking on ‘‘Comment.’’ 

(2) By hard copy: Submit by U.S. mail 

to: Public Comments Processing, Attn: 

FWS–R7–ES–2024–0117, U.S. Fish and 

Wildlife Service, MS: PRB/3W, 5275 

Leesburg Pike, Falls Church, VA 22041– 

3803. 

We request that you send comments 

only by the methods described above. 

We will post all comments on https:// 

www.regulations.gov. This generally 

means that we will post any personal 

information you provide us (see 

Information Requested, below, for more 

information). 

Availability of supporting materials: 

Supporting materials, such as the 

species status assessment report, are 

available at https://www.regulations.gov 

at Docket No. FWS–R7–ES–2024–0117. 

FOR FURTHER INFORMATION CONTACT: 

Mike Daigneault, Acting Field 

Supervisor, Southern Alaska Fish and 

Wildlife Field Office, 4700 BLM Road, 

Anchorage, AK 99507; telephone 907– 

271–1467. Individuals in the United 

States who are deaf, deafblind, hard of 

hearing, or have a speech disability may 

dial 711 (TTY, TDD, or TeleBraille) to 

access telecommunications relay 

services. Individuals outside the United 

States should use the relay services 

offered within their country to make 

international calls to the point-ofcontact in the United States. Please see 

Docket No. FWS–R7–ES–2024–0117 on 

https://www.regulations.gov for a 

document that summarizes this 

proposed rule. 

SUPPLEMENTARY INFORMATION: 

Executive Summary 

Why we need to publish a rule. Under 

the Act, a species warrants listing if it 

meets the definition of an endangered 

species (in danger of extinction 

throughout all or a significant portion of 

its range) or a threatened species (likely 

to become an endangered species within 

the foreseeable future throughout all or 

a significant portion of its range). If we 

determine that a species warrants 

listing, we must list the species 

promptly and designate the species’ 

critical habitat to the maximum extent 

prudent and determinable. We have 

determined that Suckley’s cuckoo 

bumble bee meets the Act’s definition of 

an endangered species; therefore, we are 

proposing to list it as such. Listing a 

species as an endangered or threatened 

species can be completed only by 

issuing a rule through the 

Administrative Procedure Act 

rulemaking process (5 U.S.C. 551 et 

seq.). 

What this document does. We 

propose to list Suckley’s cuckoo bumble 

bee as an endangered species under the 

Act. 

The basis for our action. Under the 

Act, we may determine that a species is 

an endangered or a threatened species 

because of any of five factors: (A) The 

present or threatened destruction, 

modification, or curtailment of its 

habitat or range; (B) overutilization for 

commercial, recreational, scientific, or 

educational purposes; (C) disease or 

predation; (D) the inadequacy of 

existing regulatory mechanisms; or (E) 

other natural or manmade factors 

affecting its continued existence. We 

have determined that Suckley’s cuckoo 

bumble bee meets the Act’s definition of 

an endangered species due to threats 


ddrumheller on DSK120RN23PROD with PROPOSALS1