95688 Federal Register / Vol. 89, No. 231 / Monday, December 2, 2024 / Proposed Rules 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 721 

[EPA–HQ–OPPT–2024–0077; FRL–12348– 

01–OCSPP] 

RIN 2070–AB27 

Significant New Use Rules on Certain 

Chemical Substances (24–2.5e) 

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 2, 2025. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPPT–2024–0077 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: Punam 

Tyagi, New Chemicals Division 

(7405M), Office of Pollution Prevention 

and Toxics, Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW, 

Washington, DC 20460–0001; telephone 

number: (202) 566–1176; email address: 

tyagi.punam@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: The TSCAHotline, 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 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 promulgated at 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 

2, 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 


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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, 

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 720, subpart E. 

Absent a final determination or other 

disposition of the confidentiality claim 

under 40 CFR part 2 procedures, 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 

for 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. 


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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 

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 following: 

• 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 

determining whether the new use is 

ongoing for these chemical substances? 

EPA designates December 2, 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: 


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• 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). 

Where EPA determined that the PMN 

substance may present an unreasonable 

risk of injury to human health via 

inhalation exposure, the underlying 

TSCA Order usually requires that 

potentially exposed employees wear 

specified respirators unless actual 

measurements of the workplace air 

show that air-borne concentrations of 

the PMN substance are below a New 

Chemical Exposure Limit (NCEL). The 

comprehensive NCELs provisions in 

TSCA Orders include requirements 

addressing performance criteria for 

sampling and analytical methods, 

periodic monitoring, respiratory 

protection, and recordkeeping. No 

comparable NCEL provisions currently 

exist in 40 CFR part 721, subpart B, for 

SNURs. Therefore, for these cases, the 

individual SNURs in 40 CFR part 721, 

subpart E, will state that persons subject 

to the SNUR who wish to pursue NCELs 

as an alternative to the 40 CFR 721.63 

respirator requirements may request to 

do so under 40 CFR 721.30. EPA expects 

that persons whose 40 CFR 721.30 

requests to use the NCELs approach for 

SNURs that are approved by EPA will 

be required to comply with NCELs 

provisions that are comparable to those 

contained in the corresponding TSCA 

Order. 

C. Which chemical substances are 

subject to this proposed rule? 

The substances subject to the 

proposed rules in this document are as 

follows: 

PMN Numbers (Proposed CFR 

Citations): P–16–377 (40 CFR 

721.11960) and P–16–378 (40 CFR 

721.11961) 

Chemical Names: Polyester polyol 

(generic). 

CASRN: Not available. 

Effective Date of TSCA Order: August 

8, 2023. 

Basis for TSCA Order: The PMNs state 

that the generic (non-confidential) uses 

will be as film components. Based on 

meeting the criteria of the PMN 

substances being insoluble in water, 

non-reactive, respirable, and being high 

molecular weight polymers, EPA has 

identified concerns for lung effects (lung 

overload). The Order was issued under 

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

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

in the absence of sufficient information 

to permit a reasoned evaluation, the 

substances may present an unreasonable 

risk of injury to human health. 

To protect against these risks, the 

Order requires: 

• No manufacture, processing, or use 

of the PMN substances in a manner that 

would result in respirable particle sizes 

below 10 microns; 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 testing may be 

potentially useful to characterize the 

health 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–18–346 (40 CFR 721.11962) 

Chemical Name: 2,4,8,10-Tetraoxa3,9-diphosphaspiro[5.5]undecane, 3,9- 

bis-[2-(1-methyl-1- phenylethyl)-4- 

(1,1,3,3-tetramethylbutyl)phenoxy]-. 

CASRN: 1507339–21–0. 

Effective Date of TSCA Order: July 25, 

2023. 

Basis for TSCA Order: The PMN states 

that the use will be as an antioxidant 

compounded into various polymers to 

be used in extrusion processes to 

fabricate articles. Based on submitted 

test data on the PMN substance, EPA 

has identified concerns for eye irritation 

and skin sensitization. Based on 

comparison to analogous chemical 

substances, EPA has also identified 

concerns for neurotoxicity, liver, spleen, 

reproductive, and developmental 

effects. Based on comparison to 

analogous neutral organic chemicals, 

EPA predicts toxicity to aquatic 

organisms may occur at concentrations 

that exceed 18 parts per billion (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 release of the PMN substance, or 

any waste stream containing the PMN 

substance, in surface water 

concentrations that exceed 18 ppb; 

• Use of personal protective 

equipment where there is a potential for 

dermal exposure; 

• Use of a NIOSH-certified respirator 

with an APF of at least 50 where there 

is a potential for inhalation exposure; 

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 

neurotoxicity, specific target organ 

toxicity, reproductive toxicity, 

developmental 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. 


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PMN Number (Proposed CFR Citation): 

P–20–44 (40 CFR 721.11963) 

Chemical Name: 1-Propanamine, 3- 

methoxy-N,N-dimethyl-. 

CASRN: 20650–07–1. 

Effective Date of Modified TSCA 

Order: June 14, 2023. 

Basis for TSCA Order: The PMN states 

that the generic (non-confidential) use 

will be as a curing additive for 

automotive paint, an additive for 

industrial polyurethane dispersions, a 

solubilizer for high acid value styrene 

acrylic polymers for use in ink 

applications, for neutralization, 

solubilization, and stability in 

commercial waterborne and solvent 

borne coatings and varnishes used for 

wood, metal, composites, and other 

substrates. Based on submitted test data 

on the new chemical substance, EPA 

has identified concerns for skin and 

respiratory irritation and serious eye 

damage. Based on comparison to 

structurally analogous chemical 

substances, EPA has also identified 

concerns for systemic toxicity, 

respiratory tract effects, and 

reproductive/developmental toxicity. 

Based on comparison to analogous 

aliphatic amines, EPA predicts toxicity 

to aquatic organisms may occur at 

concentrations that exceed 1000 ppb. 

EPA issued an Order 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. The Order was also issued 

under TSCA sections 5(a)(3)(B)(ii)(II) 

and 5(e)(1)(A)(ii)(II), based on a finding 

that the substance is or will be produced 

in substantial quantities and that the 

substance either enters or may 

reasonably be anticipated to enter the 

environment in substantial quantities, 

or there is or may be significant (or 

substantial) human exposure to the 

substance. The Order, effective October 

1, 2020, required the submitter of P–20– 

44 to submit to EPA the results of 

certain toxicity testing before any 

manufacturing (which includes import), 

processing, or use of the PMN 

substance. On May 25, 2021, the PMN 

submitter provided the results of three 

environmental toxicity studies in 

accordance with the requirements of the 

Order. EPA reviewed those studies and 

determined the studies to be valid. EPA 

subsequently modified the terms of the 

Order to mitigate any unreasonable risks 

to human health and the environment 

and issued a modified Order, effective 

June 14, 2023. To protect against these 

potential risks, the modified Order 

requires: 

• No use of the PMN substance in 

consumer products; 

• No release of the PMN substance, or 

any waste stream containing the PMN 

substance, in surface water 

concentrations that exceed 1000 ppb; 

• Use of a NIOSH-certified gas/vapor 

particulate respirator with an APF of at 

least 1000 where there is a potential for 

inhalation exposure or compliance with 

a NCEL of 1.1388mg/m3 as an 8-hour 

time-weighted average to prevent 

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 

irritation, serious eye damage, 

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–21–21 (40 CFR 721.11964) 

Chemical Name: Soybean oil, mixed 

esters with diethylene glycol, phthalic 

acid and terephthalic acid. 

CASRN: Not available. 

Effective Date of TSCA Order: July 5, 

2023. 

Basis for TSCA Order: The PMN states 

that use will be as a raw material to be 

blended into R-side components of the 

polyurethane and polyisocyanurate 

industry (specifically used in slabstock/ 

bunstock processing of foam). Based on 

the acid groups, EPA has identified 

concerns for irritation to the skin, eyes, 

and respiratory tract. Based on test data 

for a feedstock and potential metabolite, 

diethylene glycol, EPA has also 

identified concerns for systemic (body 

weight, bladder, kidney) and 

developmental effects. The Order was 

issued under TSCA sections 

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

based on a finding that in the absence 

of sufficient information to permit a 

reasoned evaluation, the substance may 

present an unreasonable risk of injury to 

human health. To protect against these 

risks, the Order requires: 

• No use of the PMN substance in 

consumer products; 

• 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 3000 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, skin irritation, eye 

damage, and specific target organ 

toxicity testing may be potentially 

useful to characterize the health effects 

of the PMN substance. Although the 

Order does not require these tests, the 

Order’s restrictions remain in effect 

until the Order is modified or revoked 

by EPA based on submission of this or 

other relevant information. 

PMN Number (Proposed CFR Citation): 

P–21–151 (40 CFR 721.11965) 

Chemical Name: Soybean oil, 

epoxidized, polymer with bisphenol A, 

alkyl glycidyl ether, epichlorohydrin, 

polyethylene glycol and 

trihydroxyalkane (generic). 

CASRN: Not available. 

Effective Date of TSCA Order: August 

16, 2023. 

Basis for TSCA Order: The PMN states 

that the generic (non-confidential) use 

will be in polyurethane applications. 

Based on the surfactant properties of the 

PMN substance, EPA has identified 

concerns for lung effects (surfactancy) if 

inhaled. Based on the potential protein 

crosslinking of multifunctional reactive 

groups and epoxides present in the 

feedstocks, EPA has also identified 

concerns for dermal and respiratory 

sensitization. Based on comparison to 

analogous nonionic surfactants, EPA 

predicts toxicity to aquatic organisms 


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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 use of the PMN substance for 

use in a consumer product; 

• No release of the PMN substance, or 

any waste stream containing the PMN 

substance, in surface water 

concentrations that exceed 140 ppb; 

• No processing or use of the PMN 

substance in a spray application; 

• Use of personal protective 

equipment where there is a potential for 

dermal exposure; 

• Use of a NIOSH-certified respirator 

with an APF of at least 1,000 where 

there is a potential for inhalation 

exposure; 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, specific target organ 

toxicity, skin sensitization, and aquatic 

toxicity testing may be potentially 

useful to characterize the health and 

environmental effects of the PMN 

substance. Although the Order does not 

require these tests, the Order’s 

restrictions remain in effect until the 

Order is modified or revoked by EPA 

based on submission of this or other 

relevant information. 

PMN Number (Proposed CFR Citation): 

P–21–168 (40 CFR 721.11966) 

Chemical Name: Metal, [heteropoly

cyclic]-, [[[(hydroxyalkyl)amino] 

sulfonyl]alkyl]sulfonyl

(sulfoalkyl)sulfonyl derivs., ammonium 

sodium salts (generic). 

CASRN: Not available. 

Effective Date of TSCA Order: 

September 22, 2023. 

Basis for TSCA Order: The PMN states 

that the generic (non-confidential) use 

will be as a colorant. Based on 

submitted test data on the PMN 

substance, EPA predicts toxicity to 

aquatic organisms may occur at 

concentrations that exceed 178 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 

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 178 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 chronic 

aquatic toxicity testing may be 

potentially useful to characterize the 

environmental effects of the PMN 

substance. Although the Order does not 

require these tests, the Order’s 

restrictions remain in effect until the 

Order is modified or revoked by EPA 

based on submission of this or other 

relevant information. 

PMN Number (Proposed CFR Citation): 

P–21–173 (40 CFR 721.11967) 

Chemical Name: Siloxanes and 

silicones polyether, polymer with 

aliphatic isocyanate, 2- 

dimethylaminoethanol and polyglycol 

ether (generic). 

CASRN: Not available. 

Effective Date of TSCA Order: June 

29, 2023. 

Basis for TSCA Order: The PMN states 

that the generic (non-confidential) use 

will be as an additive for finishing of 

textiles/fabrics. Based on structure, EPA 

has identified concerns for lung effects 

due to surfactancy. Based on 

comparison to analogous chemical 

substances, EPA has also identified 

concerns for developmental and 

systemic effects. Based on comparison 

to analogous polycationic polymers, 

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: 

• 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; 

• 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 1 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 

developmental toxicity, 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–21–194 (40 CFR 721.11968) 

Chemical Name: Siloxanes and 

Silicones, di-Me, 

[gluconoylamino)alkyl]

dialkylammonio]- hydroxyalkoxy]alkyl 

group-terminated, (salts) (generic). 

CASRN: Not available. 

Effective Date of TSCA Order: 

September 15, 2023. 

Basis for TSCA Order: The PMN states 

that the use will be as a textile softening 

agent. Based on the siloxane moieties, 

EPA has identified concerns for lung 

waterproofing. Based on comparison to 

analogous chemical substances, EPA has 

also identified concerns for irritation to 

skin and eyes. Based on comparison to 

analogous polycationic polymers, EPA 

predicts toxicity to 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 


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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 as a consumer product; 

• No release of the PMN substance, or 

any waste stream containing the PMN 

substance, in surface water 

concentrations that exceed 210 ppb; 

• 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 

metabolism or pharmacokinetics, skin 

irritation, eye 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 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–21–202 (40 CFR 721.11969) 

Chemical Name: Sulfonium, 

carbomonocycle 

bis((trihaloalkyl)carbomonocycle), 

substituted carbomonocyclic ester 

(generic). 

CASRN: Not available. 

Effective Date of TSCA Order: 

December 21, 2022. 

Basis for TSCA Order: The PMN states 

that the generic (non-confidential) use 

of the PMN substance will be as an 

ingredient used in the manufacture of 

photoresist. 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’s cation photolysis 

product will persist in the environment 

for more than six months and estimates 

a bioaccumulation factor of greater than 

or equal to 1,000. EPA also estimates 

that the PMN substance’s cation will 

persist in the environment for more than 

six months and estimates an unknown 

bioaccumulation potential based on 

uncertainty about bioaccumulation. 

Based on the photoreactivity of the PMN 

substance, EPA has identified concerns 

for photosensitization for the cation of 

the PMN substance. Based on 

comparison to chemical substances 

analogous to the sulfonium cation of the 

PMN substance and supported by 

information provided in the SDS, EPA 

has also identified concerns for acute 

toxicity, irritation to the skin, eyes, and 

respiratory tract, eye corrosion, ocular 

lethality, neurological effects, and 

systemic effects for the cation. Based on 

information provided in the SDS, EPA 

has also identified concerns for 

irritation to the skin, eyes, and 

respiratory tract and neurotoxicity. 

Based on comparison to analogous 

chemical substances, EPA has also 

identified concerns for mutagenicity for 

the cation. Based on a potential 

incineration by-product, EPA has also 

identified concerns for both local and 

systemic effects via inhalation exposure. 

Based on test data for salicylic acid and 

sodium salicylate, EPA has also 

identified concerns for acute toxicity 

(mortality), eye irritation, neurotoxicity, 

and reproductive and developmental 

effects for the anion. Based on potential 

for chelation and irritation based on 

acid groups, EPA has also identified 

concerns for developmental effects for 

the anion. 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 

or use of the PMN substance in any way 

that generates a vapor, dust, mist, or 

aerosol in a non-enclosed process; 

• Use of the PMN substance only 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 any form in sealed 

containers weighing 5 kilograms or less; 

and 

• No exceedance of the confidential 

annual importation volume listed the 

Order. 

The proposed SNUR would designate 

as a ‘‘significant new use’’ the absence 

of these protective measures. 

Potentially Useful Information: EPA 

has determined that certain information 

about the physical/chemical properties, 

fate, bioaccumulation, environmental 

hazard, and human health effects of the 

PMN substance may be potentially 

useful in support of a request by the 

PMN submitter to modify the Order, or 

if a manufacturer or processor is 

considering submitting a SNUN for a 

significant new use that will be 

designated by this SNUR. The submitter 

has agreed not to exceed the time limits 

specified in the Order without 

performing the required Tier I and Tier 

II testing outlined in the Testing section 

of the Order. 

PMN Numbers (Proposed CFR 

Citations): P–21–208 (40 CFR 

721.11970), P–21–209 (40 CFR 

721.11971), and P–21–210 (40 CFR 

721.11972) 

Chemical Names: Aromatic diacids, 

polymer with alkyldiacids, alkyldiols, 

benzofurandione, caprolactone and 1,1′- 

methylenebis[4-isocyanatobenzene] 

(generic) (P–21–208), Aromatic diacid, 

polymer with alkyldiacid, alkyldiols, 

polypropylene glycol, benzofurandione, 

caprolactone and 1,1′-methylenebis[4- 

isocyanatobenzene] (generic) (P–21– 

209), and Aromatic diacids, polymer 

with alkyldiacids, alkyldiols, 

benzofurandione, polypropylene, 

alkylhydroxyacid glycolester, 

caprolactone and 1,1′-methylenebis[4- 

isocyanatobenzene] (generic) (P–21– 

210). 

CASRN: Not available. 

Effective Date of TSCA Order: May 26, 

2023. 

Basis for TSCA Order: The PMNs state 

that the generic (non-confidential) uses 

will be as adhesives for profile 

wrapping. Based on the structure of the 

PMN substances, EPA has identified 

concerns for skin sensitization, 

respiratory sensitization, and 

genotoxicity. Based on test data for a 

feedstock residual, EPA has also 

identified concerns for acute toxicity, 

acute neurotoxicity, irritation to the 

skin, eyes, and respiratory tracts, skin 

sensitization, respiratory sensitization, 


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genotoxicity, carcinogenicity, and 

portal-of-entry systemic, reproductive, 

and developmental effects. Based on 

information provided in the SDSs for 

the feedstock residual, EPA also 

identified acute toxicity (inhalation), 

skin sensitization, respiratory 

sensitization, skin irritation, respiratory 

irritation, and eye corrosion. Based on 

Organisation for Economic Co-operation 

and Development (OECD Toolbox 

results for the feedstock residual, EPA 

also identified skin sensitization and 

respiratory sensitization. Based on test 

data for a hydrolysis product of 

feedstock residual, EPA also identified 

acute toxicity, genotoxicity, 

carcinogenicity, eye irritation, skin 

irritation, skin sensitization, and 

systemic and reproductive 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 substances 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 substances in any manner 

that results in inhalation exposure; 

• No release of the PMN substances, 

or any waste stream containing the PMN 

substances, into waters of the United 

States; 

• No processing for use or use of the 

PMN substances in consumer products; 

• 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, carcinogenicity, developmental 

toxicity, serious eye damage, genetic 

toxicity, reproductive toxicity, skin 

irritation, skin sensitization, pulmonary 

effects, and specific target organ toxicity 

testing may be potentially useful to 

characterize the health 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–21–212 (40 CFR 721.11973) 

Chemical Name: Diketone compound 

metal complex (generic). 

CASRN: Not available. 

Effective Date of TSCA Order: August 

2, 2023. 

Basis for TSCA Order: The PMN states 

that the use will be as a luminescent 

material for security ink. Based on 

submitted test data, EPA has identified 

concerns for acute toxicity and 

neurotoxicity. Based on the structure as 

a europium complex, EPA has also 

identified concerns for chelation to 

nutrient metals. Based on test data for 

analogues of the cation, EPA has also 

identified concerns for eye irritation, 

irritation/hypersensitivity reactions, and 

systemic effects. Based on test data for 

analogues of the anion, EPA has also 

identified concerns for acute toxicity, 

neurotoxicity, and systemic and 

developmental effects. Based on test 

data for an incineration product, EPA 

has also identified concerns for 

neurotoxicity, portal-of-entry, and 

systemic effects. Based on comparison 

to analogous lanthanides or rare earth 

metals, EPA predicts toxicity to aquatic 

organisms may occur at concentrations 

that exceed 13 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 in exceedance of an annual 

volume of 1,000 kg/yr; 

• 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, in surface water 

concentrations that exceed 13 ppb; 

• The PMN substance, or waste 

streams containing the PMN substance, 

must be disposed of by hazardous waste 

incineration; 

• Use of personal protective 

equipment where there is a potential for 

dermal exposure; 

• Use of a NIOSH-certified respirator 

with an APF of at least 10 where there 

is a potential for inhalation exposure; 

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, skin irritation/corrosion, 

eye irritation, specific target organ 

toxicity, pulmonary effects, 

developmental 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–21–214 (40 CFR 721.11974) 

Chemical Name: Poly(oxy-1,2- 

ethanedlyl), .alpha.,.alpha.′,.alpha.’’- 

(trialkylamino)tris[omega-hydroxy-, 

alkyl (ester) (generic). 

CASRN: Not available. 

Effective Date of TSCA Order: June 

29, 2023. 

Basis for TSCA Order: The PMN states 

that the generic (non-confidential) use 

will be as a textile finishing agent. 

Based on the structure and intended use 

as an emulsifier, EPA has identified 

concerns for lung toxicity (surfactant 

effects), and skin, eye, and respiratory 

tract irritation. Based on test data for 

alcohol ethoxylates, EPA has also 

identified concerns for developmental 

and systemic effects. Based on 

comparison to analogous aliphatic 

amines and polycationic polymers, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

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 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; 

• No release of the PMN substance, or 

any waste stream containing the PMN 

substance, in surface water 

concentrations that exceed 4 ppb; and 


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• 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, skin irritation, 

eye irritation, 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–22–18 (40 CFR 721.11975) 

Chemical Name: Substituted 

polyalkylenepoly, reaction products 

with substituted heteromonocycle 

substituted heteromonocycle 

polyalkylene derivs. (generic). 

CASRN: Not available. 

Effective Date of TSCA Order: June 

23, 2023. 

Basis for TSCA Order: The PMN states 

that the generic (non-confidential) use 

will be as a component of a lubricant. 

Based on the structure of the PMN 

substance, EPA has identified concerns 

for lung toxicity via cationic binding. 

Based on the use of the PMN substance, 

EPA has also identified concerns for 

surfactant effects on the lungs. Based on 

comparison to analogous chemical 

substances, EPA has also identified 

concerns for irritation. The Order was 

issued under TSCA sections 

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

based on a finding that in the absence 

of sufficient information to permit a 

reasoned evaluation, the substance may 

present an unreasonable risk of injury to 

human health. To protect against these 

risks, the Order requires: 

• No processing for use or use of the 

PMN substance in consumer products at 

a concentration greater than 3%; 

• No manufacture, processing, or use 

of the PMN substance in any manner 

that generates a dust, mist, or aerosol; 

• Use of personal protective 

equipment where there is a potential for 

dermal exposure; 

• No use of the PMN substance other 

than for the confidential use listed in 

the Order; 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 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–22–21 (40 CFR 721.11976) 

Chemical Name: Alkylphosphonic 

acid, calcium salt (generic). 

CASRN: Not available. 

Effective Date of TSCA Order: June 

14, 2023. 

Basis for TSCA Order: The PMN states 

that the generic (non-confidential) use 

will be as a nucleating agent for 

polyolefins. Based on comparison to 

analogous chemical substances, EPA has 

identified concerns for systemic 

(decreased body weight and blood 

effects) and reproductive (male) 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 and the 

environment. To protect against these 

risks, the Order requires: 

• No use of the PMN substance in 

consumer products other than in plastic 

articles and other plastic parts; 

• Use of personal protective 

equipment where there is a potential for 

dermal exposure; 

• Use of a NIOSH-certified respirator 

with an APF of at least 10 where there 

is a potential for inhalation exposure; 

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 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–22–32 (40 CFR 721.11977) 

Chemical Name: Isocyanic acid, 

polymethylenepolyphenylene ester, 

polymer with .alpha.-hydro-.omega.- 

hydroxypoly[oxy(alkanediyl)], 1,1′- 

methylenebis[4-isocyanatobenzene] and 

.alpha.-alkane[.omega.- 

hydroxypoly[oxy(alkanediyl)]] (generic). 

CASRN: Not available. 

Effective Date of TSCA Order: October 

5, 2023. 

Basis for TSCA Order: The PMN states 

that the use will be as a reactive 

polymer for use in adhesives and 

sealants. Based on the weight of 

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 analogues of the residuals 

of the PMN substance, EPA has also 

identified concerns for acute toxicity, 

irritation to the skin, eyes, and 

respiratory tract, skin sensitization, 

respiratory sensitization, lung effects, 

systemic effects, reproductive and 

developmental 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 manufacture, processing, or use 

of the PMN substance in any manner 

that generates vapor, mist, aerosol, or 

dust; 

• 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 


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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 

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–22–33 (40 CFR 721.11978) 

Chemical Name: Alkylamine, 

alkoxysilyl-, hydrolyzed (generic). 

CASRN: Not available. 

Effective Date of TSCA Order: October 

5, 2023. 

Basis for TSCA Order: The PMN states 

that the use will be as an adhesion 

promoter for use in industrial 

manufacturing operations. Based on the 

amine content, EPA has identified 

concerns for irritation to the skin, eye, 

and respiratory tract. Based on potential 

for cationic binding to lung membranes, 

waterproofing, and comparison to 

analogous alkoxysilanes, EPA has also 

identified concerns for lung effects. 

Based on the expected release of a 

hydrolysis product, EPA has also 

identified concerns for neurotoxicity 

and developmental effects. Based on 

comparison to analogous polycationic 

polymers, 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: 

• No manufacture, processing, or use 

of the PMN substance in any manner 

that generates vapor, mist, aerosol, or 

dust; 

• 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; 

• 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, 

skin irritation/corrosion, eye irritation/ 

corrosion, reproductive/developmental 

toxicity, neurotoxicity, 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–22–34 (40 CFR 721.11979) 

Chemical Name: Alkylphosphonic 

acid, disodium salt (generic). 

CASRN: Not available. 

Effective Date of TSCA Order: June 

14, 2023. 

Basis for TSCA Order: The PMN states 

that the generic (non-confidential) use 

will be as a precursor to a nucleating 

agent for polyolefins. Based on 

comparison to analogous chemical 

substances, 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 and the environment. 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 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–22–35 (40 CFR 721.11980) 

Chemical Name: Alkenoic acid, 

alkanediyl ester, polymer with 

bis(substituted alkyl)-alkanediol 

polymer with alkylene oxides alkenoate, 

and alkanamine (generic). 

CASRN: Not available. 

Effective Date of TSCA Order: June 1, 

2023. 

Basis for TSCA Order: The PMN states 

that the use will be as a component of 

flexographic ink formulations to 

improve reactivity when cured under 

LED UV light. Based on comparison to 

analogous acrylates/methacrylates and 

cross-linking potential, EPA has 

identified concerns for irritation to the 

skin, eyes and respiratory tract, and skin 

and respiratory sensitization. Based on 

the structure of the PMN substance, EPA 

has also identified concerns for lung 

effects (cationic binding). Based on 

comparison to analogues of both the low 

molecular weight fraction and the 

residual, EPA also identified concerns 

for acute toxicity, skin irritation/ 

corrosion, eye irritation/corrosion, 

respiratory tract irritation/corrosion, 

skin sensitization, neurotoxicity, and 

systemic and reproductive (male) 

effects. Based on comparison to 

analogous polycationic polymers, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

3 ppb. The Order was issued under 

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

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

in the absence of sufficient information 

to permit a reasoned evaluation, the 


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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 

consumer products; 

• No release of the PMN substance, or 

any waste stream containing the PMN 

substance, in surface water 

concentrations that exceed 3 ppb; 

• Use of a NIOSH-certified particulate 

respirator with an APF of at least 1000 

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 aquatic 

toxicity, specific target organ toxicity, 

pulmonary effects, reproductive/ 

developmental toxicity, skin 

sensitization, skin irritation/corrosion, 

eye irritation/corrosion, acute toxicity, 

and neurotoxicity 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–22–38 (40 CFR 721.11981) 

Chemical Name: Siloxanes and 

silicones, di-Me, mixed (polyhydrosubstituted heterocyclic) alkyl group 

and [(polyalkylsilyl)substituted]- 

terminated (generic). 

CASRN: Not available. 

Effective Date of TSCA Order: 

September 29, 2023. 

Basis for TSCA Order: The PMN states 

that the generic (non-confidential) use 

will be as an additive. Based on 

comparison to analogous chemical 

substances, EPA has identified lung, 

reproductive, and 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 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; 

• 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 

pulmonary effects, specific target organ 

toxicity, and reproductive 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–22–94 (40 CFR 721.11982) 

Chemical Name: Cadmium tin oxide 

(Cd2Sn04). 

CASRN: 12185–56–7. 

Effective Date of TSCA Order: October 

25, 2023. 

Basis for TSCA Order: The PMN states 

that the generic (non-confidential) use 

will be for a contained use as a 

sputtering material. Based on 

comparison to analogous respirable, 

poorly soluble particulates, EPA has 

identified concerns for lung effects (lung 

overload and subsequent 

carcinogenicity). Based on test data for 

components and information provided 

in the SDS, EPA has also identified 

concerns for acute toxicity, irritation to 

the skin, eyes, and respiratory tract, 

systemic effects, reproductive and 

developmental effects, genotoxicity, and 

carcinogenicity. Based on comparison to 

analogous chemical substances, EPA 

predicts toxicity to aquatic organisms 

may occur at concentrations that exceed 

0.2 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 domestic manufacture of the 

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

• No 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; 

• No 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; 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 aquatic 

toxicity, sediment toxicity, specific 

target organ toxicity, acute toxicity, 

pulmonary effects, reproductive 

toxicity, developmental toxicity, skin 

irritation, eye damage, carcinogenicity, 

and genetic 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–22–119 (40 CFR 

721.11983) and P–22–120 (40 CFR 

721.11984) 

Chemical Names: 

Polyhydroxyalkanoate (generic). 

CASRN: Not applicable. 

Effective Date of TSCA Order: 

September 29, 2023. 

Basis for TSCA Order: The PMNs state 

that the generic (non-confidential) uses 

will be as resins for packaging materials 

and for use as binders. Based on 

comparison to analogous chemical 

substances, EPA has identified concerns 


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for skin, eye, and respiratory tract 

irritation. The Order was issued under 

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

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

in the absence of sufficient information 

to permit a reasoned evaluation, the 

substances may present an unreasonable 

risk of injury to human health. To 

protect against these risks, the Order 

requires: 

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. 

The proposed SNUR would designate 

as a ‘‘significant new use’’ the absence 

of these protective measures. 

Potentially Useful Information: EPA 

has determined that certain information 

may be potentially useful in support of 

a request by the PMN submitter to 

modify the Order, or if a manufacturer 

or processor is considering submitting a 

SNUN for a significant new use that will 

be designated by this SNUR. EPA has 

determined that the results of eye 

irritation, pulmonary effects, and skin 

irritation testing may be potentially 

useful to characterize the health 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–22–151 (40 CFR 721.11985) 

Chemical Name: Glycolipids, 

sophorose-contg., yeast-fermented, from 

glycerides and carbohydrates (generic). 

CASRN: Not available. 

Effective Date of TSCA Order: August 

29, 2023. 

Basis for TSCA Order: The PMN states 

that the generic (non-confidential) use 

will be as a surfactant for commercial 

applications. Based on the intended use 

of the new chemical substance as well 

as submitted surface tension data, EPA 

has identified concerns for lung effects 

(surfactancy). Based on test data for 

components and information provided 

in the SDS, EPA has identified concerns 

for eye and respiratory tract irritation 

and systemic effects. Based on 

comparison to analogous aliphatic 

amines, EPA predicts toxicity to aquatic 

organisms may occur at concentrations 

that exceed 550 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; 

• No release of the PMN substance, or 

any waste stream containing the PMN 

substance, in surface water 

concentrations that exceed 550 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 

pulmonary effects, 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–22–178 (40 CFR 721.11986) 

Chemical Name: Aromatic diacid, 

polymer with alkyldiols, hexanedioic 

acid, benzofurandione, and 1,1′- 

methylenebis[4-isocyanatobenzene] 

(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 an adhesive for lamination. 

Based on comparison to analogous 

diisocyanates, EPA has identified 

concerns for skin sensitization, 

respiratory sensitization, and 

pulmonary toxicity. Based on test data 

for the feedstock residual, EPA has also 

identified concerns for acute toxicity, 

skin and respiratory sensitization, 

irritation to the skin, eyes, and 

respiratory tract, and systemic, 

pulmonary, and developmental effects. 

Based on test data for a hydrolysis 

product of a residual, EPA has also 

identified concerns for genetic toxicity, 

carcinogenicity, and portal-of-entry, 

systemic, and reproductive 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 manufacture, processing, or use 

of the PMN substance in any manner 

that results in inhalation exposure; 

• No manufacture, processing, or use 

of the PMN substance with residual MDI 

greater than 5% by weight; 

• No processing for use or use of the 

PMN substance in consumer products; 

• 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, 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 

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–23–13 (40 CFR 721.11987) 

Chemical Name: Phenol, polymer 

with 4,4′- bis(chloromethyl)-1,1′- 

biphenyl. 

CASRN: 208254–04–0. 

Effective Date of TSCA Order: 

November 2, 2023. 

Basis for TSCA Order: The PMN states 

that the use will be as an epoxy molding 

compound for electronic devices. Based 

on comparison to analogous chemical 

substances, EPA has identified concerns 

for portal-of-entry effects (GI effects). 


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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: 

• Manufacture of the PMN substance 

other than by import into the United 

States (i.e., no domestic manufacture) at 

concentrations equal to or less than the 

confidential concentration percentage 

listed in the Order; 

• No release of the PMN substance, or 

any waste stream containing the PMN 

substance, in surface water 

concentrations that exceed 260 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 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 Numbers (Proposed CFR 

Citations): P–23–49 (40 CFR 721.11988) 

and P–23–124 (40 CFR 721.11989) 

Chemical Names: Sulfonium, 

tricarbocyclic-, 2-arylpolyfluoropolyhydro-alkano 

-heteropolycycle-alkanesulfonate (1:1), 

polymer with heteroatom substituted 

aryl and carbomonocyclic 2-alkyl-2- 

alkanoate, di-Me 2,2-(1,2- 

diazenediyl)bis[2-methylpropanoate]- 

initiated (generic) (P–23–49) and 

Sulfonium, tricabocyclic-, 2-heteroatomsubstituted-(halocarbocyclic)carboxylate 

(1:1) (generic) (P–23–124). 

CASRN: Not available. 

Effective Date of TSCA Order: 

September 25, 2023. 

Basis for TSCA Order: The PMNs state 

that the generic (non-confidential) use 

of the PMN substances will be for 

photolithography. Based on the 

physical/chemical properties of the 

PMN substances (as described in the 

New Chemical Program’s PBT category 

at 64 FR 60194; November 1999) and 

test data on structurally similar 

substances, the PMN 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 estimates a 

bioaccumulation factor of greater than 

or equal to 1,000. Based on the presence 

of 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 of the PMN substances. Based on 

comparison to analogous chemical 

substances, EPA has also identified 

concerns for genetic toxicity for the 

cation of the PMN substances. Based on 

the photoreactivity of the PMN 

substances, EPA has also identified 

concerns for photosensitization for the 

cation of the PMN substances. Based on 

a structural alert and OECD QSAR 

(Quantitative Structure-Activity 

Relationship) Toolbox results, EPA has 

also identified concerns for skin 

sensitization for the anion of P–23–124. 

Based on a potential incineration 

product, EPA has also identified 

concerns for local and systemic effects 

for the incineration product. 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 

of the PMN substances in any way that 

generates a vapor, dust, mist, or aerosol 

in a non-enclosed process; 

• Use of the PMN substances only 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–23–50 (40 CFR 721.11990) 

Chemical Name: Substituted

heterocyclic onium compound, salt with 

heteropolysubstitutedalkyl substituted

tricycloalkanecarboxylate (1:1), polymer 

with 3-ethenylphenol and 

heterosubstitutedaromaticalkyl 2- 

methyl-2-propenoate, di-Me 2,2′-(1,2- 

diazenediyl)bis[2- methylpropanoate]- 

initiated (generic). 

CASRN: Not available. 

Effective Date of TSCA Order: 

September 20, 2023. 

Basis for TSCA Order: The PMN states 

that the generic (non-confidential) use 

of the PMN substance will be for 

contained use for microlithography for 

electronic device manufacturing. Based 

on the physical/chemical properties of 

the PMN substance (as described in the 

New Chemical Program’s PBT category 

at 64 FR 60194; November 1999) and 

test data on structurally similar 

substances, the PMN substance is a 

potentially persistent, bioaccumulative, 

and toxic (PBT) chemical. EPA 

estimates that the PMN substance will 

persist in the environment for more than 

six months and estimates a 

bioaccumulation factor of greater than 

or equal to 1,000. Based on comparison 

to chemical substances analogous to the 

cation compounds of the PMN 

substance and supported by information 

provided in the SDS, EPA has identified 

concerns for acute toxicity, irritation to 

the skin and respiratory tract, eye 

corrosion, neurological effects, and 

systemic effects for the cation of the 

PMN substance. Based on comparison to 

analogous chemical substances, EPA has 

also identified concerns for genetic 

toxicity for the cation of the PMN 

substance. Based on the photoreactivity 


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of the PMN substance, EPA has also 

identified concerns for 

photosensitization for the cation of the 

PMN substance. Based on a potential 

incineration product, EPA has also 

identified concerns for local and 

systemic effects for the incineration 

product. 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 

or use of the PMN substance in any way 

that generates a vapor, dust, mist, or 

aerosol in a non-enclosed process; 

• Use of the PMN substance only 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. 

PMN Numbers (Proposed CFR 

Citations): P–23–83 (40 CFR 721.11991), 

P–23–125 (40 CFR 721.11992), and P– 

23–147 (40 CFR 721.11993) 

Chemical Names: Sulfonium, 

tricarbocyclic-, [polyhydro-alkyl- 

(polyfluoro-2-heteroatom substituted)- 

alkano-heteromonocyclic] alkyl ester 

(1:1) (generic) (P–23–83), Sulfonium, 

tricarbocyclic-, polyfluoropolyhydroheteroatom substituted 

carbomonocyclic-2-heteroatom 

substituted carbomonocyclic 

heteropolycycle-5-alkanesulfonate (1:1) 

(generic) (P–23–125), and Sulfonium, 

tris(heteroatom-substituted 

carbomonocyclic), salt with polyhydropolyfluoro-heteroatom-substituted alkyl 

heteropolycyclic-heteroatom-substituted 

aryl heteroatom-substituted benzoate 

(1:1) (generic) (P–23–147). 

CASRN: Not available. 

Effective Date of TSCA Order: October 

27, 2023. 

Basis for TSCA Order: The PMNs state 

that the generic (non-confidential) use 

of the PMN substances will be for 

photolithography. Based on the 

physical/chemical properties of the 

PMN substances (as described in the 

New Chemical Program’s PBT category 

at 64 FR 60194; November 1999) and 

test data on structurally similar 

substances, the PMN substances are 

potentially persistent, bioaccumulative, 

and toxic (PBT) chemicals. EPA 

estimates that the PMN substances will 

persist in the environment for more than 

six months and estimates a 

bioaccumulation factor of greater than 

or equal to 1,000. Based on the presence 

of 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 of the PMN substances. Based on 

comparison to analogous chemical 

substances, EPA has also identified 

concerns for genetic toxicity for the 

sulfonium cation of the PMN 

substances. Based on the photoreactivity 

of the PMN substances, EPA has also 

identified concerns for 

photosensitization for the sulfonium 

cation of the PMN substances. Based on 

comparison to analogous chemical 

substances, EPA has also identified 

concerns for systemic and 

developmental effects for the anion 

component of the PMN substances. 

Based on a potential incineration 

product, EPA has also identified 

concerns for local and systemic effects 

via inhalation exposure for the 

incineration product of the PMN 

substances. Based on OECD Toolbox 

results, EPA also identified concerns for 

skin sensitization for the anion 

component of P–23–147. 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 

of the PMN substances in any way that 

generates a vapor, dust, mist, or aerosol 

in a non-enclosed process; 

• Use of the PMN substances only 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–23–104 (40 CFR 721.11994) 

Chemical Name: Sulfonium, 

carbomonocycle 

bis[(trihaloalkyl)carbomonocycle], 

disubstituted carbomonocyclic ester 

(generic). 

CASRN: Not available. 

Effective Date of TSCA Order: 

September 29, 2023. 


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Basis for TSCA Order: The PMN states 

that the generic (non-confidential) use 

of the PMN substance will be an 

ingredient used in the manufacture of 

photoresist. 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 1,000. Based 

on the presence of 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 cation of the 

PMN substance. Based on comparison to 

analogous chemical substances, EPA has 

also identified concerns for genetic 

toxicity for the cation of the PMN 

substance. Based on the photoreactivity 

of the PMN substance, EPA has also 

identified concerns for 

photosensitization for the cation of the 

PMN substance. Based on a potential 

incineration product, EPA has also 

identified concerns for local and 

systemic effects for the incineration 

product. 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 processing of the PMN 

substance in any way that generates a 

vapor, dust, mist, or aerosol in a nonenclosed 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, 

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 


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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 

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. 

Dated: November 22, 2024. 

Mary Elissa Reaves, 

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). 

■ 2. Add §§ 721.11960 through 

721.11994 to Subpart E to read as 

follows: 

Subpart E—Significant New Uses for 

Specific Chemical Substances 

Sec. 

* * * * * 

721.11960 Polyester polyol (generic). 

721.11961 Polyester polyol (generic). 

721.11962 2,4,8,10-Tetraoxa-3,9- 

diphosphaspiro[5.5]undecane, 3,9-bis-[2- 

(1-methyl-1- phenylethyl)-4-(1,1,3,3- 

tetramethylbutyl)phenoxy]-. 

721.11963 1-Propanamine, 3-methoxy-N,Ndimethyl-. 

721.11964 Soybean oil, mixed esters with 

diethylene glycol, phthalic acid and 

terephthalic acid. 

721.11965 Soybean oil, epoxidized, 

polymer with bisphenol A, alkyl glycidyl 

ether, epichlorohydrin, polyethylene 

glycol and trihydroxyalkane (generic). 

721.11966 Metal, [heteropolycyclic]-, 

[[[(hydroxyalkyl)amino] sulfonyl]

alkyl]sulfonyl(sulfoalkyl)sulfonyl 

derivs., ammonium sodium salts 

(generic). 

721.11967 Siloxanes and silicones 

polyether, polymer with aliphatic 

isocyanate, 2-dimethylaminoethanol and 

polyglycol ether (generic). 

721.11968 Siloxanes and Silicones, di-Me, 

[gluconoylamino)alkyl]dialkylammonio]- 

hydroxyalkoxy]alkyl group-terminated, 

(salts) (generic). 

721.11969 Sulfonium, carbomonocycle 

bis((trihaloalkyl)carbomonocycle), 

substituted carbomonocyclic ester 

(generic). 

721.11970 Aromatic diacids, polymer with 

alkyldiacids, alkyldiols, 

benzofurandione, caprolactone and 1,1′- 

methylenebis[4-isocyanatobenzene] 

(generic). 

721.11971 Aromatic diacid, polymer with 

alkyldiacid, alkyldiols, polypropylene 

glycol, benzofurandione, caprolactone 

and 1,1′-methylenebis[4- 

isocyanatobenzene] (generic). 

721.11972 Aromatic diacids, polymer with 

alkyldiacids, alkyldiols, 

benzofurandione, polypropylene, 

alkylhydroxyacid glycolester, 

caprolactone and 1,1′-methylenebis[4- 

isocyanatobenzene] (generic). 

721.11973 Diketone compound metal 

complex (generic). 


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721.11974 Poly(oxy-1,2-ethanedlyl), 

alpha,alpha′′,alpha′′-(trialkylamino)

tris[omega-hydroxy-, alkyl (ester) 

(generic). 

721.11975 Substituted polyalkylenepoly, 

reaction products with substituted 

heteromonocycle substituted 

heteromonocycle polyalkylene derivs 

(generic). 

721.11976 Alkylphosphonic acid, calcium 

salt (generic). 

721.11977 Isocyanic acid, polymethylene

polyphenylene ester, polymer with 

.alpha.-hydro-.omega.whydroxypoly[oxy(alkanediyl)], 1,1′- 

methylenebis[4-isocyanatobenzene] and 

.alpha.-alkane[.omega.whydroxypoly[oxy(alkanediyl)]] (generic). 

721.11978 Alkylamine, alkoxysilyl-, 

hydrolyzed (generic). 

721.11979 Alkylphosphonic acid, disodium 

salt (generic). 

721.11980 Alkenoic acid, alkanediyl ester, 

polymer with bis(substituted alkyl)- 

alkanediol polymer with alkylene oxides 

alkenoate, and alkanamine (generic). 

721.11981 Siloxanes and silicones, di-Me, 

mixed (polyhydro-substituted 

heterocyclic) alkyl group and 

[(polyalkylsilyl)substituted]-terminated 

(generic). 

721.11982 Cadmium tin oxide (Cd2Sn04). 

721.11983 Polyhydroxyalkanoate (generic). 

721.11984 Polyhydroxyalkanoate (generic). 

721.11985 Glycolipids, sophorose-contg., 

yeast-fermented, from glycerides and 

carbohydrates (generic). 

721.11986 Aromatic diacid, polymer with 

alkyldiols, hexanedioic acid, 

benzofurandione, and 1,1′- 

methylenebis[4-isocyanatobenzene] 

(generic). 

721.11987 Phenol, polymer with 4,4′- 

bis(chloromethyl)-1,1′-biphenyl. 

721.11988 Sulfonium, tricarbocyclic-, 2- 

aryl- polyfluoropolyhydro-alkano 

-heteropolycycle-alkanesulfonate (1:1), 

polymer with heteroatom substituted 

aryl and carbomonocyclic 2-alkyl-2- 

alkanoate, di-Me 2,2-(1,2- 

diazenediyl)bis[2-methylpropanoate]- 

initiated (generic). 

721.11989 Sulfonium, tricabocyclic-, 2- 

heteroatom-substituted- 

(halocarbocyclic)carboxylate (1:1) 

(generic). 

721.11990 Substitutedheterocyclic onium 

compound, salt with 

heteropolysubstitutedalkyl 

substitutedtricycloalkanecarboxylate 

(1:1), polymer with 3-ethenylphenol and 

heterosubstitutedaromaticalkyl 2-methyl2-propenoate, di-Me 2,2′-(1,2- 

diazenediyl)bis[2- methylpropanoate]- 

initiated (generic). 

721.11991 Sulfonium, tricarbocyclic-, 2- 

aryl- polyfluoropolyhydro-alkano 

-heteropolycycle-alkanesulfonate (1:1), 

polymer with heteroatom substituted 

aryl and carbomonocyclic 2-alkyl-2- 

alkanoate, di-Me 2,2-(1,2- 

diazenediyl)bis[2-methylpropanoate]- 

initiated (generic). 

721.11992 Sulfonium, tricarbocyclic-, 

polyfluoropolyhydro-heteroatom 

substituted carbomonocyclic-2- 

heteroatom substituted carbomonocyclic 

heteropolycycle-5-alkanesulfonate (1:1) 

(generic). 

721.11993 Sulfonium, tris(heteroatomsubstituted carbomonocyclic), salt with 

polyhydro-polyfluoro-heteroatomsubstituted alkyl heteropolycyclicheteroatom-substituted aryl heteroatomsubstituted benzoate (1:1) (generic). 

721.11994 Sulfonium, carbomonocycle 

bis[(trihaloalkyl)carbomonocycle], 

disubstituted carbomonocyclic ester 

(generic). 

* * * * * 

§ 721.11960 Polyester polyol (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as polyester polyol (PMN P– 

16–377) 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) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (f), and (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. 

(ii) Industrial, commercial, and 

consumer use. It is a significant new use 

to manufacture, process, or use the 

substance in any manner that would 

result in respirable particle sizes below 

10 microns. 

(b) Specific requirements. The 

provisions of Subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c), and (f) through 

(i) are applicable to manufacturers, 

importers, and processors of this 

substance. 

(2) Limitation or revocation of certain 

notification requirements. The 

provisions of § 721.185 apply to this 

section. 

§ 721.11961 Polyester polyol (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as polyester polyol (PMN P– 

16–378) 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) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (f), and (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. 

(ii) Industrial, commercial, and 

consumer use. It is a significant new use 

to manufacture, process, or use the 

substance in any manner that would 

result in respirable particle sizes below 

10 microns. 

(b) Specific requirements. The 

provisions of Subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c), and (f) through 

(i) are applicable to manufacturers, 

importers, and processors of this 

substance. 

(2) Limitation or revocation of certain 

notification requirements. The 

provisions of § 721.185 apply to this 

section. 

§ 721.11962 2,4,8,10-Tetraoxa-3,9- 

diphosphaspiro[5.5]undecane, 3,9-bis-[2-(1- 

methyl-1- phenylethyl)-4-(1,1,3,3- 

tetramethylbutyl)phenoxy]-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

2,4,8,10-tetraoxa-3,9- 

diphosphaspiro[5.5]undecane, 3,9-bis- 

[2-(1-methyl-1- phenylethyl)-4-(1,1,3,3- 

tetramethylbutyl)phenoxy]- (PMN P– 

18–346; CASRN 1507339–21–0) 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 (5), 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), and (g)(1), (3), and (5). 

For purposes of § 721.72(g)(1), this 


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substance may cause: skin sensitization, 

eye 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) Release to water. Requirements as 

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

(c)(4), where N=18. 

(b) Specific requirements. The 

provisions of Subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitation or revocation of certain 

notification requirements. The 

provisions of § 721.185 apply to this 

section. 

§ 721.11963 1-Propanamine, 3-methoxyN,N-dimethyl-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

1-propanamine, 3-methoxy-N,Ndimethyl- (PMN P–20–44; CASRN 

20650–07–1) 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 (5), (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 1000. For purposes of 

§ 721.63(b), the concentration is set at 

1.0%. 

(A) As an alternative to the respirator 

requirements in paragraph (a)(2)(i) of 

this section, a manufacturer or processor 

may choose to follow the new chemical 

exposure limit (NCEL) provision listed 

in the TSCA section 5(e) Order for this 

substance. The NCEL is 1.1388mg/m3 as 

an 8-hour time weighted average. 

Persons who wish to pursue NCELs as 

an alternative to § 721.63 respirator 

requirements may request to do so 

under § 721.30. Persons who § 721.30 

requests to use the NCELs approach are 

approved by EPA will be required to 

follow NCELs provisions comparable to 

those contained in the corresponding 

TSCA section 5(e) Order. 

(B) [Reserved] 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (f), and (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: skin irritation, 

serious eye damage, 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 use. 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=1000. 

(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. 

§ 721.11964 Soybean oil, mixed esters with 

diethylene glycol, phthalic acid and 

terephthalic acid. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

soybean oil, mixed esters with 

diethylene glycol, phthalic acid and 

terephthalic acid (PMN P–21–21) 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) 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) 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, 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 use. Requirements as 

specified in § 721.80(o). It is a 

significant new use to manufacture, 

process, or use the substance in any 

manner that results in inhalation 

exposure. 

(iv) Release to water. Requirements as 

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

(c)(4), where N=3000. 

(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. 

§ 721.11965 Soybean oil, epoxidized, 

polymer with bisphenol A, alkyl glycidyl 

ether, epichlorohydrin, polyethylene glycol 

and trihydroxyalkane (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as soybean oil, epoxidized, 

polymer with bisphenol A, alkyl 

glycidyl ether, epichlorohydrin, 

polyethylene glycol and 

trihydroxyalkane (PMN P–21–151) 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 

when 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) through (5), 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), and (g)(1) through (3), 

and (5). For purposes of § 721.72(g)(1), 

this substance may cause: respiratory 

sensitization, skin sensitization, and 

specific target organ toxicity. For 

purposes of § 721.72(g)(2), do not spray 

apply. 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 use. Requirements as 

specified in § 721.80(o). It is a 

significant new use to process or use the 

substance in a spray application. 

(iv) Release to water. Requirements as 

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

(c)(4), where N=140. 

(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. 

§ 721.11966 Metal, [heteropolycyclic]-, 

[[[(hydroxyalkyl)amino] 

sulfonyl]alkyl]sulfonyl(sulfoalkyl)sulfonyl 

derivs., ammonium sodium salts (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as metal, [heteropolycyclic]- 

, [[[(hydroxyalkyl)amino] sulfonyl]

alkyl]sulfonyl(sulfoalkyl)sulfonyl 

derivs., ammonium sodium salts (PMN 

P–21–168) 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) Hazard communication. 

Requirements as specified in § 721.72(a) 

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

purposes of § 721.72(e), the 

concentration is set at 1.0%. 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. 

(ii) Release to water. Requirements as 

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

(c)(4), where N=178. 

(b) Specific requirements. The 

provisions of Subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c), (f) through (h), 

and (k) are applicable to manufacturers, 

importers, and processors of this 

substance. 

(2) Limitation or revocation of certain 

notification requirements. The 

provisions of § 721.185 apply to this 

section. 

§ 721.11967 Siloxanes and silicones 

polyether, polymer with aliphatic 

isocyanate, 2-dimethylaminoethanol and 

polyglycol ether (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as siloxanes and silicones 

polyether, polymer with aliphatic 

isocyanate, 2-dimethylaminoethanol 

and polyglycol ether (PMN P–21–173) is 

subject to reporting under this section 

for the significant new uses described in 

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

requirements of this section do not 

apply to quantities of the substance after 

they have been embedded into a textile 

fiber matrix. 

(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 

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 use. Requirements as 

specified in § 721.80(o). It is a 

significant new use to manufacture, 

process, or use the substance in any 

manner that results in inhalation 

exposure. 

(iv) Release to water. Requirements as 

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

(c)(4), where N=1. 

(b) Specific requirements. The 

provisions of Subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitation or revocation of certain 

notification requirements. The 

provisions of § 721.185 apply to this 

section. 

§ 721.11968 Siloxanes and Silicones, diMe, [gluconoylamino)

alkyl]dialkylammonio]- hydroxyalkoxy]alkyl 

group-terminated, (salts) (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as siloxanes and silicones, 

di-Me, [gluconoylamino)

alkyl]dialkylammonio]- 

hydroxyalkoxy]alkyl group-terminated, 

(salts) (PMN P–21–194) 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 

when incorporated into a textile. 

(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 

purposes of § 721.72(e), the 

concentration is set at 1.0%. For 

purposes of § 721.72(g)(1), this 


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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 use. 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 the generation of 

a vapor, mist, dust, or aerosol. 

(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. 

§ 721.11969 Sulfonium, carbomonocycle 

bis((trihaloalkyl)carbomonocycle), 

substituted carbomonocyclic ester 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as sulfonium, 

carbomonocycle 

bis((trihaloalkyl)carbomonocycle), 

substituted carbomonocyclic ester (PMN 

P–21–202) 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), and (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, unless 

in sealed containers weighing 5 

kilograms or less. It is a significant new 

use to process the substance in any way 

that generates dust, mist, or aerosol in 

a non-enclosed process. It is a 

significant new use to manufacture the 

substance longer than 9 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. 

§ 721.11970 Aromatic diacids, polymer 

with alkyldiacids, alkyldiols, 

benzofurandione, caprolactone and 1,1′- 

methylenebis[4-isocyanatobenzene] 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as aromatic diacids, polymer 

with alkyldiacids, alkyldiols, 

benzofurandione, caprolactone and 1,1′- 

methylenebis[4-isocyanatobenzene] 

(PMN P–21–208) 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), and (g)(1) and (5). For 

purposes of § 721.72(g)(1), this 

substance may cause: acute toxicity, 

skin irritation, serious eye damage, 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 use. Requirements as 

specified in § 721.80(o). It is a 

significant new use to manufacture, 

process, or use the substance in any 

manner that results in inhalation 

exposure. 

(iv) Release to water. Requirements as 

specified in § 721.90(a)(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. 

§ 721.11971 Aromatic diacid, polymer with 

alkyldiacid, alkyldiols, polypropylene 

glycol, benzofurandione, caprolactone and 

1,1′-methylenebis[4-isocyanatobenzene] 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as aromatic diacid, polymer 

with alkyldiacid, alkyldiols, 

polypropylene glycol, benzofurandione, 

caprolactone and 1,1′-methylenebis[4- 

isocyanatobenzene] (PMN P–21–209) 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 


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

purposes of § 721.72(g)(1), this 

substance may cause: acute toxicity, 

skin irritation, serious eye damage, 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 use. Requirements as 

specified in § 721.80(o). It is a 

significant new use to manufacture, 

process, or use the substance in any 

manner that results in inhalation 

exposure. 

(iv) Release to water. Requirements as 

specified in § 721.90(a)(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. 

§ 721.11972 Aromatic diacids, polymer 

with alkyldiacids, alkyldiols, 

benzofurandione, polypropylene, 

alkylhydroxyacid glycolester, caprolactone 

and 1,1′-methylenebis[4- 

isocyanatobenzene] (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as aromatic diacids, polymer 

with alkyldiacids, alkyldiols, 

benzofurandione, polypropylene, 

alkylhydroxyacid glycolester, 

caprolactone and 1,1′-methylenebis[4- 

isocyanatobenzene] (PMN P–21–210) 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), and (f), and (g)(1) and (5). 

For purposes of § 721.72(g)(1), this 

substance may cause: acute toxicity, 

skin irritation, serious eye damage, 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 use. Requirements as 

specified in § 721.80(o). It is a 

significant new use to manufacture, 

process, or use the substance in any 

manner that results in inhalation 

exposure. 

(iv) Release to water. Requirements as 

specified in § 721.90(a)(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. 

§ 721.11973 Diketone compound metal 

complex (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as diketone compound metal 

complex (PMN P–21–212) 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 

when completely entrained in dried/ 

cured ink. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (3) through (5), 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), and (g)(1), (3), and (5). 

For purposes of § 721.72(g)(1), this 

substance may cause: acute toxicity, 

skin corrosion, serious eye damage, skin 

irritation, eye irritation, skin 

sensitization, reproductive toxicity, and 

specific target organ toxicity. For 

purposes of § 721.72(g)(3), this 

substance may be: toxic to aquatic life. 

Alternative hazard and warning 

statements that meet the criteria of the 

Globally Harmonized System and OSHA 

Hazard Communication Standard may 

be used. 

(iii) Industrial, commercial, and 

consumer use. Requirements as 

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

significant new use to manufacture the 

substance in excess of an annual volume 

of 1,000 kg/yr. 

(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)(4), (b)(4), and 

(c)(4), where N=13. 

(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. 

§ 721.11974 Poly(oxy-1,2-ethanedlyl), 

alpha,alpha′,alpha′′- 

(trialkylamino)tris[omega-hydroxy-, alkyl 

(ester) (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 


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generically as poly(oxy-1,2-ethanedlyl), 

alpha,alpha′,alpha′′- 

(trialkylamino)tris[omega-hydroxy-, 

alkyl (ester) (PMN P–21–214) 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 embedded into a textile 

fiber matrix. 

(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 

purposes of § 721.72(e), the 

concentration is set at 1.0%. For 

purposes of § 721.72(g)(1), this 

substance may cause: skin irritation, eye 

irritation, reproductive toxicity, 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 use. Requirements as 

specified in § 721.80(o). It is a 

significant new use to manufacture, 

process, or use the substance in any 

manner that results in inhalation 

exposure. 

(iv) Release to water. Requirements as 

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

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

(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. 

§ 721.11975 Substituted polyalkylenepoly, 

reaction products with substituted 

heteromonocycle substituted 

heteromonocycle polyalkylene derivs 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as substituted 

polyalkylenepoly, reaction products 

with substituted heteromonocycle 

substituted heteromonocycle 

polyalkylene derivs. (PMN P–22–18) is 

subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) 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) 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. 

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 use. Requirements as 

specified in § 721.80(k). It is a 

significant new use to process for use or 

use the substance in consumer products 

at a concentration greater than 3%. It is 

a significant new use to manufacture, 

process, or use the substance in any 

manner that results in a dust, mist, or 

aerosol. 

(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. 

§ 721.11976 Alkylphosphonic acid, 

calcium salt (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as alkylphosphonic acid, 

calcium salt (PMN P–22–21) 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 fully reacted, cured, 

destroyed, or entrained in a polymer 

matrix. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(1), (3) through (5), (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), and (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 use. It is a significant new use 

to use the substance in consumer 

products other than in plastic articles 

and other plastic parts. 

(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. 


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§ 721.11977 Isocyanic acid, 

polymethylenepolyphenylene ester, 

polymer with .alpha.-hydro-.omega.- 

hydroxypoly[oxy(alkanediyl)], 1,1′- 

methylenebis[4-isocyanatobenzene] and 

.alpha.-alkane[.omega.- 

hydroxypoly[oxy(alkanediyl)]] (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as isocyanic acid, 

polymethylenepolyphenylene ester, 

polymer with .alpha.-hydro-.omega.- 

hydroxypoly[oxy(alkanediyl)], 1,1′- 

methylenebis[4-isocyanatobenzene] and 

.alpha.-alkane[.omega.- 

hydroxypoly[oxy(alkanediyl)]] (PMN P– 

22–32) 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), and (g)(1) and (5). For 

purposes of § 721.72(g)(1), this 

substance may cause: acute toxicity 

(residual), skin irritation (residual), eye 

irritation (residual), skin sensitization, 

respiratory sensitization, genetic 

toxicity (residual), carcinogenicity 

(residual), reproductive toxicity 

(residual), 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 use. 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 a vapor, mist, 

aerosol, or dust. 

(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. 

§ 721.11978 Alkylamine, alkoxysilyl-, 

hydrolyzed (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as alkylamine, alkoxysilyl-, 

hydrolyzed (PMN P–22–33) 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), and (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, specific target organ toxicity, 

and reproductive 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 use. 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 a vapor, mist, 

aerosol, or dust. 

(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. 

§ 721.11979 Alkylphosphonic acid, 

disodium salt (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as alkylphosphonic acid, 

disodium salt (PMN P–22–34) 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 fully reacted, cured, 

destroyed, or entrained in a polymer 

matrix. 

(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) 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 use. Requirements as 

specified in § 721.80(o). It is a 

significant new use to manufacture, 

process, or use the substance in any 

manner that results in inhalation 

exposure. 

(b) Specific requirements. The 

provisions of Subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

manufacturers, importers, and 

processors of this substance. 


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(2) Limitation or revocation of certain 

notification requirements. The 

provisions of § 721.185 apply to this 

section. 

§ 721.11980 Alkenoic acid, alkanediyl 

ester, polymer with bis(substituted alkyl)- 

alkanediol polymer with alkylene oxides 

alkenoate, and alkanamine (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as alkenoic acid, alkanediyl 

ester, polymer with bis(substituted 

alkyl)-alkanediol polymer with alkylene 

oxides alkenoate, and alkanamine (PMN 

P–22–35) 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 (5), 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 1000. 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (d), (f), and (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, 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 use. 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=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. 

§ 721.11981 Siloxanes and silicones, diMe, mixed (polyhydro-substituted 

heterocyclic) alkyl group- and 

[(polyalkylsilyl)substituted]-terminated 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as siloxanes and silicones, 

di-Me, mixed (polyhydro-substituted 

heterocyclic) alkyl group- and 

[(polyalkylsilyl)substituted]-terminated 

(PMN P–22–38) 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), and (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 use. Requirements as 

specified in § 721.80(o). It is a 

significant new use to manufacture, 

process, or use the substance in any 

manner that results in inhalation 

exposure. 

(iv) Release to water. Requirements as 

specified in § 721.90(a)(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. 

§ 721.11982 Cadmium tin oxide (Cd2Sn04). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

cadmium tin oxide (Cd2Sn04) (PMN P– 

22–94; CASRN 12185–56–7) 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. 

(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 

0.1%. 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (f), and (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: skin irritation, eye 

irritation, genetic toxicity, specific target 

organ toxicity, acute toxicity, 

reproductive toxicity, and 

carcinogenicity. For purposes of 

§ 721.72(g)(3), this substance may be: 

toxicity 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 use. Requirements as 

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

significant new use to manufacture, 

process, or use the substance in any 

manner that results in inhalation 

exposure. 

(iv) Release to water. Requirements as 

specified in § 721.90(a)(1), (b)(1), and 

(c)(1). 

(b) Specific requirements. The 

provisions of Subpart A of this part 


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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. 

§ 721.11983 Polyhydroxyalkanoate 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as polyhydroxyalkanoate 

(PMN P–22–119) 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 plastic or when completely reacted or 

cured or when 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 (5), (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), and (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: skin irritation, eye 

irritation, 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. 

(b) Specific requirements. The 

provisions of Subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (h) 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. 

§ 721.11984 Polyhydroxyalkanoate 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as polyhydroxyalkanoate 

(PMN P–22–120) 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 plastic or when completely reacted or 

cured or when 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 (5), (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), and (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: skin irritation, eye 

irritation, 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. 

(b) Specific requirements. The 

provisions of Subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (h) 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. 

§ 721.11985 Glycolipids, sophorosecontg., yeast-fermented, from glycerides 

and carbohydrates (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as glycolipids, sophorosecontg., yeast-fermented, from glycerides 

and carbohydrates (PMN P–22–151) 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 

purposes of § 721.72(e), the 

concentration is set at 1.0%. For 

purposes of § 721.72(g)(1), this 

substance may cause: eye irritation 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 use. Requirements as 

specified in § 721.80(o). It is a 

significant new use to manufacture, 

process, or use the substance in any 

manner that results in inhalation 

exposure. 

(iv) Release to water. Requirements as 

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

(c)(4), where N=550. 

(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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§ 721.11986 Aromatic diacid, polymer with 

alkyldiols, hexanedioic acid, 

benzofurandione, and 1,1′- methylenebis[4- 

isocyanatobenzene] (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as aromatic diacid, polymer 

with alkyldiols, hexanedioic acid, 

benzofurandione, and 1,1′- 

methylenebis[4-isocyanatobenzene] 

(PMN P–22–178) 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), and (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 use. 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. It is a significant new use to 

manufacture, process, or use the 

substance with residual MDI greater 

than 5% by weight. 

(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. 

§ 721.11987 Phenol, polymer with 4,4′- 

bis(chloromethyl)-1,1′-biphenyl. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

phenol, polymer with 4,4′- 

bis(chloromethyl)-1,1′-biphenyl (PMN 

P–23–13; CASRN 208254–04–0) is 

subject to reporting under this section 

for the significant new uses described in 

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

requirements of this section do not 

apply to quantities of the substance after 

they have been completely reacted or 

cured. 

(2) The significant new uses are: 

(i) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (f), and (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. 

(ii) Industrial, commercial, and 

consumer use. It is a significant new use 

to manufacture the substance other than 

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

domestic manufacture) at 

concentrations equal to or greater than 

the confidential concentration 

percentage listed in the Order. 

(iii) Release to water. Requirements as 

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

(c)(4), where N=260. 

(b) Specific requirements. The 

provisions of Subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c), (f) 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. 

§ 721.11988 Sulfonium, tricarbocyclic-, 2- 

aryl- polyfluoropolyhydro-alkano 

-heteropolycycle-alkanesulfonate (1:1), 

polymer with heteroatom substituted aryl 

and carbomonocyclic 2-alkyl-2-alkanoate, 

di-Me 2,2-(1,2-diazenediyl)bis[2- 

methylpropanoate]-initiated (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as sulfonium, 

tricarbocyclic-, 2-arylpolyfluoropolyhydro-alkano 

-heteropolycycle-alkanesulfonate (1:1), 

polymer with heteroatom substituted 

aryl and carbomonocyclic 2-alkyl-2- 

alkanoate, di-Me 2,2-(1,2- 

diazenediyl)bis[2-methylpropanoate]- 

initiated (PMN P–23–49) 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 

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 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 


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provisions of § 721.185 apply to this 

section. 

§ 721.11989 Sulfonium, tricabocyclic-, 2- 

heteroatom-substituted- 

(halocarbocyclic)carboxylate (1:1) (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as sulfonium, 

tricabocyclic-, 2-heteroatom-substituted- 

(halocarbocyclic)carboxylate (1:1) 

(generic) (PMN P–23–124) 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), and (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 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. 

§ 721.11990 Substitutedheterocyclic 

onium compound, salt with 

heteropolysubstitutedalkyl 

substitutedtricycloalkanecarboxylate (1:1), 

polymer with 3-ethenylphenol and 

heterosubstitutedaromaticalkyl 2-methyl-2- 

propenoate, di-Me 2,2′-(1,2- 

diazenediyl)bis[2- methylpropanoate]- 

initiated (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as substitutedheterocyclic 

onium compound, salt with 

heteropolysubstitutedalkyl 

substitutedtricycloalkanecarboxylate 

(1:1), polymer with 3-ethenylphenol and 

heterosubstitutedaromaticalkyl 2- 

methyl-2-propenoate, di-Me 2,2′-(1,2- 

diazenediyl)bis[2- methylpropanoate]- 

initiated (PMN P–23–50) 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), and (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 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. 

§ 721.11991 Sulfonium, tricarbocyclic-, 2- 

aryl- polyfluoropolyhydro-alkano 

-heteropolycycle-alkanesulfonate (1:1), 

polymer with heteroatom substituted aryl 

and carbomonocyclic 2-alkyl-2-alkanoate, 

di-Me 2,2-(1,2-diazenediyl)bis[2- 

methylpropanoate]-initiated (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as sulfonium, 

tricarbocyclic-, 2-aryl- polyfluor

opolyhydro-alkano -heteropolycyclealkanesulfonate (1:1), polymer with 

heteroatom substituted aryl and 

carbomonocyclic 2-alkyl-2-alkanoate, 

di-Me 2,2-(1,2-diazenediyl)bis[2- 

methylpropanoate]-initiated (PMN P– 

23–83) is subject to reporting under this 

section for the significant new uses 

described in paragraph (a)(2) of this 

section. The requirements of this section 

do not apply to quantities of the 

substance after they have been 

completely reacted 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 


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considered and implemented to prevent 

exposure, where feasible. 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (d), (f), and (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. 

§ 721.11992 Sulfonium, tricarbocyclic-, 

polyfluoropolyhydro-heteroatom 

substituted carbomonocyclic-2-heteroatom 

substituted carbomonocyclic 

heteropolycycle-5-alkanesulfonate (1:1) 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as sulfonium, 

tricarbocyclic-, polyfluoropolyhydroheteroatom substituted 

carbomonocyclic-2-heteroatom 

substituted carbomonocyclic 

heteropolycycle-5-alkanesulfonate (1:1) 

(PMN P–23–125) 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), and (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. 

§ 721.11993 Sulfonium, tris(heteroatomsubstituted carbomonocyclic), salt with 

polyhydro-polyfluoro-heteroatomsubstituted alkyl heteropolycyclicheteroatom-substituted aryl heteroatomsubstituted benzoate (1:1) (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as sulfonium, 

tris(heteroatom-substituted 

carbomonocyclic), salt with polyhydropolyfluoro-heteroatom-substituted alkyl 

heteropolycyclic-heteroatom-substituted 

aryl heteroatom-substituted benzoate 

(1:1) (PMN P–23–147) 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), and (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. 


ddrumheller on DSK120RN23PROD with PROPOSALS5
95716 Federal Register / Vol. 89, No. 231 / Monday, December 2, 2024 / Proposed Rules 

§ 721.11994 Sulfonium, carbomonocycle 

bis[(trihaloalkyl)carbomonocycle], 

disubstituted carbomonocyclic ester 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as sulfonium, 

carbomonocycle 

bis[(trihaloalkyl)carbomonocycle], 

disubstituted carbomonocyclic ester 

(PMN P–23–104) 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), and (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 

process the substance in any way that 

generates dust, mist, or aerosol in a nonenclosed process. It is a significant new 

use to manufacture the substance longer 

than 9 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. 2024–27912 Filed 11–29–24; 8:45 am] 

BILLING CODE 6560–50–P 


ddrumheller on DSK120RN23PROD with PROPOSALS5