87346 Federal Register / Vol. 88, No. 241 / Monday, December 18, 2023 / Rules and Regulations 

Inbound Letter Post letters and flats will 

increase to $8.45. 

• International Business ReplyTM

Mail Service: The price for IBRS cards 

will increase to $2.15, and the price for 

IBRS envelopes (up to 2 ounces) will 

increase to $2.70. 

New prices will be listed in the 

updated Notice 123, Price List. 

Ruth Stevenson, 

Attorney, Ethics and Legal Compliance. 

[FR Doc. 2023–27760 Filed 12–15–23; 8:45 am] 

BILLING CODE 7710–12–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 9 and 721 

[EPA–HQ–OPPT–2022–0462; FRL–10183– 

03–OCSPP] 

RIN 2070–AB27 

Significant New Use Rules on Certain 

Chemical Substances (22–2.5e) 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: EPA is issuing 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 designated as a significant new use by 

this rule to notify EPA at least 90 days 

before commencing that activity. The 

required notification initiates EPA’s 

evaluation of the use, under the 

conditions of use for that chemical 

substance, within the applicable review 

period. Persons may not commence 

manufacture or processing for the 

significant new use until they have 

submitted a Significant New Use Notice 

(SNUN), and EPA has conducted a 

review of the notice, made an 

appropriate determination on the notice, 

and has taken such actions as are 

required by that determination. 

DATES: This rule is effective on February 

16, 2024. For purposes of judicial 

review, this rule shall be promulgated at 

1 p.m. (EST) on January 2, 2024. 

ADDRESSES: The docket for this action, 

identified under docket identification 

(ID) number EPA–HQ–OPPT–2022– 

0462, is available online at https://

www.regulations.gov or in person at the 

Office of Pollution Prevention and 

Toxics Docket (OPPT Docket) in the 

Environmental Protection Agency 

Docket Center (EPA/DC). Please review 

the visitor instructions and additional 

information about the docket available 

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

FOR FURTHER INFORMATION CONTACT: 

For technical information contact: 

William Wysong, New Chemicals 

Division (7405M), Office of Pollution 

Prevention and Toxics, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave. NW, Washington, DC 20460–0001; 

telephone number: (202) 564–4163; 

email address: wysong.william@epa.gov. 

For general information contact: The 

TSCA-Hotline, ABVI-Goodwill, 422 

South Clinton Ave., Rochester, NY 

14620; telephone number: (202) 554– 

1404; email address: TSCA-Hotline@

epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. 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 four TSCA section 5(a)(2) 

factors listed in Unit II.A.1. 

B. What action is the Agency taking? 

EPA is finalizing these SNURs under 

TSCA section 5(a)(2) for certain 

chemical substances that were the 

subject of PMNs. This document 

addresses final rules for 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 final 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). 

Previously, EPA proposed SNURs for 

these chemical substances in the 

Federal Register of October 31, 2022 (87 

FR 65548) (FRL–10183–02–OCSPP). The 

docket includes information considered 

by the Agency in developing the 

proposed and final rules, including 

public comments and EPA’s responses 

to the public comments received. The 

proposed SNURs for certain chemical 

substances not included in this Federal 

Register document will be addressed in 

a future Federal Register document. 

C. Why is the Agency taking this action? 

The Agency is issuing these SNURs to 

ensure that EPA receives timely 

advanced notice of any future 

manufacturing (including importing) or 

processing of the chemical substances 

subject to these proposed SNURs for 

uses identified as significant new uses, 

and to ensure that an appropriate 

determination (relevant to the potential 

risks associated with such 

manufacturing (including importing), 

processing, distribution in commerce, 

use and disposal) has been issued prior 

to the commencement of such 

manufacturing (including importing) or 

processing. The SNURs are necessary to 

ensure that manufacturing (including 

import) or processing for significant 

new uses cannot proceed until EPA has 

responded to the planned new use 

circumstances by taking the required 

actions under TSCA sections 5(e) or 5(f) 

in the event that EPA determines that: 

(1) The significant new use presents 

an unreasonable risk under the 

conditions of use (without consideration 

of costs or other non-risk factors, and 

including an unreasonable risk to a 

potentially exposed or susceptible 

subpopulation (PESS) identified as 

relevant by EPA); 

(2) The information available to EPA 

is insufficient to permit a reasoned 

evaluation of the health and 

environmental effects of the significant 

new use; 

(3) In the absence of sufficient 

information, the manufacturing 

(including importing), processing, 

distribution in commerce, use, or 

disposal of the substance, or any 

combination of such activities, may 

present an unreasonable risk (without 

consideration of costs or other non-risk 

factors, and including an unreasonable 

risk to a PESS identified as relevant by 

EPA); or 

(4) There is substantial production 

and sufficient potential for 

environmental release or human 

exposure (as defined in TSCA section 

5(a)(3)(B)(ii)(II)). 

For manufacturing (including 

importing) or processing for the 

significant new use to proceed after EPA 

has made one of these four 

determinations, EPA must take actions 

under TSCA sections 5(e) or 5(f) to 

protect health and the environment. 

However, EPA may also determine that 

the significant new use is not likely to 

present an unreasonable risk under 

TSCA section 5(a)(3)(C), after which 

manufacturing (including importing) or 


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Federal Register / Vol. 88, No. 241 / Monday, December 18, 2023 / Rules and Regulations 87347 

processing for the significant new use 

may proceed. 

The rationale and objectives for this 

SNUR are further explained in Unit II.B. 

D. Does this action apply to me? 

1. General Applicability 

This action may apply to you if you 

manufacture (defined by statute to 

include import), process, or use the 

chemical substances addressed in this 

Federal Register document. 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 affect certain 

entities through pre-existing import 

certification and export notification 

rules under TSCA. Chemical importers 

are subject to the TSCA section 13 (15 

U.S.C. 2612), import provisions 

promulgated at 19 CFR 12.118 through 

12.127 (see also 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. 

In addition, pursuant to 40 CFR 

721.20, this action may also apply to 

any persons who export or intend to 

export a chemical substance identified 

in this document is subject to the export 

notification provisions of TSCA section 

12(b) (15 U.S.C. 2611(b)) (see 40 CFR 

721.20), and must comply with the 

export notification requirements in 40 

CFR part 707, subpart D. 

E. What are the estimated incremental 

impacts of this action? 

EPA has evaluated the potential costs 

of establishing SNUR reporting 

requirements for potential 

manufacturers (including importers) 

and processors of the chemical 

substances included in these 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 $26,700 per SNUN 

submission for large business submitters 

and $11,000 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 

$19,020 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 $3,300 

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

fiscal year 2022. The costs of 

submission for SNUNs will not be 

incurred by any company unless a 

company decides to pursue a significant 

new use as defined in these SNURs. 

Additionally, these estimates reflect the 

costs and fees as they are known at the 

time of this rulemaking. 

2. Estimated Costs for Export 

Notifications 

EPA has also evaluated the potential 

costs associated with the export 

notification requirements under TSCA 

section 12(b) and the implementing 

regulations at 40 CFR part 707, subpart 

D. For persons exporting a substance 

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

notice to EPA must be provided for the 

first export or intended export to a 

particular country. The total costs of 

export notification will vary by 

chemical, depending on the number of 

required notifications (i.e., the number 

of countries to which the chemical is 

exported). While EPA is unable to make 

any estimate of the likely number of 

export notifications for the chemical 

substances covered by these SNURs, as 

stated in the accompanying economic 

analysis, the estimated cost of the export 

notification requirement on a per unit 

basis is approximately $106. 

II. Background 

A. Significant New Use Determination 

1. 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 addition to the factors enumerated 

in TSCA section 5(a)(2), the statute 

authorizes EPA to consider any other 

relevant factors. 

2. Scientific Standards, Evidence, and 

Available Information 

EPA has used reasonably available 

information, as well as technical 

procedures, measures, methods, 

protocols, methodologies, and models 

consistent with the best available 

science, as applicable. These 

information sources supply information 

relevant to whether a particular use 

would be a significant new use, based 

on relevant factors including those 

listed under TSCA section 5(a)(2). 

The clarity and completeness of the 

data, assumptions, methods, quality 

assurance, and analyses employed in 

EPA’s decision are documented, as 

applicable and to the extent necessary 

for purposes of the proposed SNURs, in 

the references cited throughout the 

preamble of this proposed rule. The 

extent to which the various information, 

procedures, measures, methods, 

protocols, methodologies or models 

used in EPA’s decision have been 

subject to independent verification or 

peer review is adequate to justify their 

use, collectively, in the record for a 

significant new use rule. 

3. Determination for These Chemical 

Substances 

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 

possible uses of these chemical 

substances, in the context of the four 

TSCA section 5(a)(2) factors listed in 

Unit II.A.1. 

These 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 SNURs identify 

significant new uses as any 

manufacturing, processing, use, 

distribution in commerce, or disposal 

that does not conform to the restrictions 

imposed by the underlying TSCA 

Orders, consistent with TSCA section 

5(f)(4). 


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B. Rationale and Objectives 

1. Rationale 

During review of the PMNs submitted 

for the chemical substances that are 

subject to these SNURs, EPA concluded 

that regulation was warranted under 

TSCA section 5(e), pending the 

development of information sufficient to 

make reasoned evaluations of the health 

or environmental effects of the chemical 

substances. The basis for such findings 

is outlined in Unit V. of the proposed 

rule for each chemical. Based on these 

findings, TSCA section 5(e) Orders 

requiring the use of appropriate 

exposure controls were negotiated with 

the PMN submitters. As a general 

matter, EPA believes it is necessary to 

follow the TSCA Orders with a SNUR 

that identifies the absence of those 

protective measures as 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 issuing these SNURs because 

the Agency wants to 

• Receive notice of any person’s 

intent to manufacture or process a listed 

chemical substance for the described 

significant new use before that activity 

begins. 

• Have an opportunity to review and 

evaluate data submitted in a SNUN 

before the notice submitter begins 

manufacturing or processing a listed 

chemical substance for the described 

significant new use; and 

• 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 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. 

C. Applicability of General Provisions 

General provisions for SNURs appear 

in 40 CFR part 721, subpart A. These 

provisions describe persons required to 

submit a Significant New Use Notice 

(SNUN), recordkeeping requirements, 

and exemptions to reporting 

requirements, among other things. 

Provisions relating to user fees appear 

at 40 CFR part 700. Pursuant to 40 CFR 

721.1(c), persons submitting a SNUN are 

subject to the same requirements and 

regulatory procedures as submitters of 

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

These include the information 

submission requirements of TSCA 

sections 5(b) and 5(d)(1), the 

exemptions authorized by TSCA 

sections 5(h)(1), (h)(2), (h)(3), and (h)(5), 

and the regulations at 40 CFR part 720, 

except where modified in part 721. 

Once EPA receives a SNUN, and 

before the manufacture or processing for 

the significant new use can commence, 

EPA must either determine that the use 

addressed in the SNUN is not likely to 

present an unreasonable risk of injury 

under the conditions of use for the 

chemical substance or take such 

regulatory action as is associated with 

an alternative determination. If EPA 

determines that the use is not likely to 

present an unreasonable risk, EPA is 

required under TSCA section 5(g) to 

make public, and submit for publication 

in the Federal Register, a statement of 

EPA’s findings. 

D. Applicability of the Significant New 

Use Designation 

Any use that EPA determines in the 

final rule was ongoing as of the date of 

publication of the proposal and did not 

cease prior to issuance of the final rule, 

will not be designated as a significant 

new use in the final rule. EPA has no 

information to suggest that any of the 

significant new uses identified in this 

rule are ongoing. 

Under the procedures in 40 CFR 

721.11 a manufacturer or processor may 

request EPA to determine whether a 

specific use would be a 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 and must identify 

the specific use for which it intends 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 any 

confidential significant new use 

designations under the rule. 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 to identify 

if a chemical substance is subject to 40 

CFR part 721 and if a specific use would 

be a significant new use under the rule. 

The chemical substances subject to 

this rule have undergone 

premanufacture review. In cases where 

EPA has not received a notice of 

commencement (NOC) and the chemical 

substance is not on the TSCA Inventory, 

no person may commence any activities 

without first submitting a PMN. 

Therefore, when EPA has received a 

PMN for a chemical substance but has 

not received a NOC for that same 

substance, the fact that a NOC has not 

been received is evidence that no 

manufacturing or processing of the 

chemical substance is occuring in the 

United States. When chemical 

substances identified in this rule are 

added to the TSCA Inventory, EPA 

recognizes that, before the rule is 

effective, other persons might engage in 

a use that has been identified as a 

significant new use. However, TSCA 

Orders have been issued for these 

chemical substances, and the PMN 

submitters are prohibited by the TSCA 

Orders from undertaking activities 

which would be designated as 

significant new uses. The identities of 

many of the chemical substances subject 

to these SNURs have been claimed as 

confidential per 40 CFR 720.85. 

As discussed in the Federal Register 

of April 24, 1990 (55 FR 17376 (FRL– 

3658–5)), EPA has decided that the 

intent of TSCA section 5(a)(1)(B) is best 

served by designating a use as a 

significant new use as of the date of 

publication of the proposed rule rather 

than as of the effective date of the final 

rule. The objective of EPA’s approach is 

to ensure that a person cannot impede 

finalization of a SNUR by initiating a 

significant new use after publication of 

the proposed rule but before the 

effective date of the final rule. Uses 

arising after the publication of the 

proposed rule are distinguished from 

uses that are identified in the final rule 

as having been ongoing on the date of 

publication of the proposed rule. The 

former would be new uses, the latter 

ongoing uses, except that uses that are 

identified as ongoing as of the 

publication of the proposed rule would 

not be considered ongoing uses if they 

have ceased by the date of issuance of 

a final rule. 

In the unlikely event that before a 

final rule becomes effective a person 

begins commercial manufacturing 

(including importing) or processing of 

the chemical substances for a use that is 

designated as a significant new use in 

that final rule, such a person would 

have to cease any such activity upon the 

effective date of the final rule. To 

resume their activities, these persons 

would have to first comply with all 

applicable SNUR notification 

requirements and wait until all TSCA 

prerequisites for the commencement of 


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Federal Register / Vol. 88, No. 241 / Monday, December 18, 2023 / Rules and Regulations 87349 

manufacture or processing have been 

satisfied. 

Issuance of a SNUR for a chemical 

substance does not signify that the 

chemical substance is listed on the 

TSCA Chemical Substance Inventory 

(TSCA Inventory). Guidance on how to 

determine if a chemical substance is on 

the TSCA Inventory is available on the 

internet at https://www.epa.gov/tscainventory. 

E. Important Information About SNUN 

Submissions 

1. SNUN Submissions 

According to 40 CFR 721.1(c), persons 

submitting a SNUN must comply with 

the same notification requirements and 

EPA regulatory procedures as persons 

submitting a PMN, including 

submission of test data on health and 

environmental effects as described in 40 

CFR 720.50. SNUNs must be submitted 

on EPA Form No. 7710–25, generated 

using e-PMN software, and submitted to 

the Agency in accordance with the 

procedures set forth in 40 CFR 720.40. 

E–PMN software is available 

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

reviewing-new-chemicals-under-toxicsubstances-control-act-tsca. 

2. Development and Submission of 

Information With the SNUN 

EPA recognizes that TSCA section 5 

does not require developing any 

particular new information (e.g., 

generating test data) before submission 

of a SNUN. There is an exception: If a 

person is otherwise required to submit 

information for a chemical substance 

subject to the SNUR pursuant to a rule, 

TSCA Order or consent agreement 

under TSCA section 4, then TSCA 

section 5(b)(1)(A) requires such 

information to be submitted to EPA at 

the time of submission of the SNUN. 

In the absence of a rule, Order, or 

consent agreement under TSCA section 

4 covering the chemical substance, 

persons are required only to submit 

information in their possession or 

control and to describe any other 

information known or reasonably 

ascertainable (see 40 CFR 720.50). 

However, upon review of PMNs and 

SNUNs, the Agency may determine 

under TSCA section 5(e) that it is 

necessary to require appropriate testing. 

Unit IV. of the proposed rule lists 

potentially useful information for the 

SNURs listed in this document. 

Descriptions of this information is 

provided for informational purposes. 

The potentially useful information 

identified in Unit IV. of the proposed 

rule will be useful to EPA’s evaluation 

in the event that someone submits a 

SNUN for the significant new use. 

EPA strongly encourages persons to 

consult with the Agency before 

performing any testing. Furthermore, 

pursuant to TSCA section 4(h), which 

pertains to reduction of testing in 

vertebrate animals, EPA encourages 

dialog with the Agency on the use of 

alternative test methods and strategies 

(also called New Approach 

Methodologies, or NAMs), if available, 

to generate the recommended test data. 

EPA encourages dialog with Agency 

representatives to help determine how 

best the submitter can meet both the 

data needs and the objective of TSCA 

section 4(h). For more information on 

alternative test methods and strategies 

to reduce vertebrate animal testing, visit 

https://www.epa.gov/assessing-andmanaging-chemicals-under-tsca/ 

alternative-test-methods-and-strategiesreduce. 

The potentially useful information 

listed in Unit IV. of the proposed rule 

may not be the only means of 

addressing the potential risks of the 

chemical substance. However, 

submitting a SNUN without any test 

data or other information may increase 

the likelihood that EPA will take action 

under TSCA 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 which provide detailed 

information on the following: 

• Human exposure and 

environmental release that may result 

from the significant new use of the 

chemical substances. 

• Information on risks posed by the 

chemical substances compared to risks 

posed by potential substitutes. 

III. Public Comments on Proposed Rule 

and EPA Responses 

EPA received public comments on the 

proposed rules from seven identifying 

entities. The Agency’s responses are 

presented in the Response to Public 

Comments document that is available in 

the docket for this rulemaking. EPA is 

not finalizing the SNUR applicable to 

PMN P–20–0105, which was proposed 

as 40 CFR 721.11764. As described in 

the response to comments EPA will repropose and finalize that SNUR in a 

future action. 

IV. Substances Subject to This Rule 

EPA is establishing significant new 

use and recordkeeping requirements for 

certain chemical substances in 40 CFR 

part 721, subpart E. In Unit V. of the 

proposed SNURs, EPA provided the 

following information for each chemical 

substance: 

• PMN number. 

• Chemical name (generic name, if 

the specific name is claimed as 

confidential business information 

(CBI)). 

• Chemical Abstracts Service Registry 

Number (CAS RN) (if assigned for nonconfidential chemical identities). 

• Effective date of and basis for the 

TSCA Order. 

• Potentially Useful Information. This 

is information identified by EPA that 

would help characterize the potential 

health and/or environmental effects of 

the chemical substances if a 

manufacturer or processor is 

considering submitting a SNUN for a 

significant new use designated by the 

SNUR. 

• CFR citation assigned in the 

regulatory text section of these rules. 

The regulatory text specifies the 

activities designated as significant new 

uses. Certain new uses, including 

production volume limits and other 

uses designated in the rules, may be 

claimed as CBI. In cases where the rules 

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. 

V. 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 establishes 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 


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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 associated with SNURs 

have already been approved by OMB 

pursuant to the PRA under OMB control 

number 2070–0038 (EPA ICR No. 

1188.13). This action does not impose 

any burden requiring additional OMB 

approval. If an entity were to submit a 

SNUN to the Agency, the annual burden 

is estimated to average between 30 and 

170 hours per response. This burden 

estimate includes the time needed to 

review instructions, search existing data 

sources, gather and maintain the data 

needed, and complete, review, and 

submit the required SNUN. 

EPA is amending the table in 40 CFR 

part 9 to list the SNURs and OMB 

approval number for the information 

collection activities contained in this 

action. This listing of the OMB control 

numbers and their subsequent 

codification in the CFR satisfies the 

display requirements of PRA and OMB’s 

implementing regulations at 5 CFR part 

1320. The Information Collection 

Request (ICR) covering the SNUR 

activities was previously subject to 

public notice and comment prior to 

OMB approval, and given the technical 

nature of the table, EPA finds that 

further notice and comment to amend it 

is unnecessary. As a result, EPA finds 

that there is ‘‘good cause’’ under section 

553(b)(3)(B) of the Administrative 

Procedure Act (5 U.S.C. 553(b)(3)(B)) to 

amend this table without further notice 

and comment. 

EPA always welcomes your feedback 

on the burden estimate. Send any 

comments about the accuracy of the 

burden estimate, and any suggested 

methods for minimizing respondent 

burden, including through the use of 

automated collection techniques, to the 

Director, Regulatory Support Division, 

Office of Mission Support (2822T), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW, Washington, 

DC 20460–0001. Please remember to 

include the OMB control number in any 

correspondence, but do not submit any 

completed forms to this address. 

C. Regulatory Flexibility Act (RFA) 

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 SNUNs per year. For 

example, the number of SNUNs 

received was 10 in Federal fiscal year 

(FY) FY2016, 14 in FY2017, 16 in 

FY2018, five in FY2019, seven in 

FY2020, and 13 in FY2021, and only a 

fraction of these were from small 

businesses. 

In addition, the Agency currently 

offers relief to qualifying small 

businesses by reducing the SNUN 

submission fee from $19,020 to $3,330. 

This lower fee reduces the total 

reporting and recordkeeping cost of 

submitting a SNUN to about $11,164 per 

SNUN submission for qualifying small 

firms. Therefore, the potential economic 

impacts of complying with this SNUR 

are not expected to be significant or 

adversely impact a substantial number 

of small entities. In a SNUR that 

published in the Federal Register of 

June 2, 1997 (62 FR 29684) (FRL–5597– 

1), the Agency presented its general 

determination that SNURs are not 

expected to have a significant economic 

impact on a substantial number of small 

entities, which was provided to the 

Chief Counsel for Advocacy of the Small 

Business Administration. 

D. Unfunded Mandates Reform Act 

(UMRA) 

Based on EPA’s experience with 

proposing and finalizing SNURs, State, 

local, and Tribal governments have not 

been impacted by these rulemakings, 

and EPA does not have any reasons to 

believe that any State, local, or Tribal 

government will be impacted by this 

action. As such, EPA has determined 

that this action does not impose any 

enforceable duty, contain any unfunded 

mandate, or otherwise have any effect 

on small governments subject to the 

requirements of UMRA sections 202, 

203, 204, or 205 (2 U.S.C. 1501 et seq.). 

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 Tribe 

Governments 

This action does 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 

human health, 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 rule. 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. 


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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 

This action does not concern human 

health or environmental conditions and 

therefore cannot be evaluated with 

respect to the potential for 

disproportionate impacts on non-white 

and low-income populations in 

accordance with Executive Order 12898 

(59 FR 7629, February 16, 1994) and 

Executive Order 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 allows EPA to assess 

the intended uses to identify potential 

disproportionate risks and take 

appropriate actions before the activities 

commence. 

K. Congressional Review Act (CRA) 

This action is subject to the CRA (5 

U.S.C. 801 et seq.), and EPA will submit 

a rule report to each House of the 

Congress and to the Comptroller General 

of the United States. This action is not 

a ‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 

List of Subjects 

40 CFR Part 9 

Environmental protection, Reporting 

and recordkeeping requirements. 

40 CFR Part 721 

Environmental protection, Chemicals, 

Hazardous substances, Reporting and 

recordkeeping requirements. 

Dated: December 12, 2023. 

Mary Elissa Reaves, 

Director, Office of Pollution Prevention and 

Toxics. 

Therefore, for the reasons stated in the 

preamble, 40 CFR chapter I is amended 

as follows: 

PART 9—OMB APPROVALS UNDER 

THE PAPERWORK REDUCTION ACT 

■ 1. The authority citation for part 9 

continues to read as follows: 

Authority: 7 U.S.C. 135 et seq., 136–136y; 

15 U.S.C. 2001, 2003, 2005, 2006, 2601–2671; 

21 U.S.C. 331j, 346a; 31 U.S.C. 9701; 33 

U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 

1321, 1326, 1330, 1342, 1344, 1345 (d) and 

(e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, 

1971–1975 Comp. p. 973; 42 U.S.C. 241, 

242b, 243, 246, 300f, 300g, 300g–1, 300g–2, 

300g–3, 300g–4, 300g–5, 300g–6, 300j–1, 

300j–2, 300j–3, 300j–4, 300j–9, 1857 et seq., 

6901–6992k, 7401–7671q, 7542, 9601–9657, 

11023, 11048. 

■ 2. Amend the table in § 9.1 by adding 

entries for §§ 721.11752 through 

721.11763 and 721.11765 through 

721.11776 in numerical order under the 

undesignated center heading 

‘‘Significant New Uses of Chemical 

Substances’’ to read as follows: 

§ 9.1 OMB approvals under the Paperwork 

Reduction Act. 

* * * * * 

40 CFR citation OMB control 

No. 

* * * * * 

Significant New Uses of Chemical 

Substances 

* * * * * 

721.11752 ................................. 2070–0038 

721.11753 ................................. 2070–0038 

721.11754 ................................. 2070–0038 

721.11755 ................................. 2070–0038 

721.11756 ................................. 2070–0038 

721.11757 ................................. 2070–0038 

721.11758 ................................. 2070–0038 

721.11759 ................................. 2070–0038 

721.11760 ................................. 2070–0038 

721.11761 ................................. 2070–0038 

721.11762 ................................. 2070–0038 

721.11763 ................................. 2070–0038 

721.11765 ................................. 2070–0038 

721.11766 ................................. 2070–0038 

721.11767 ................................. 2070–0038 

721.11768 ................................. 2070–0038 

721.11769 ................................. 2070–0038 

721.11770 ................................. 2070–0038 

721.11771 ................................. 2070–0038 

721.11772 ................................. 2070–0038 

721.11773 ................................. 2070–0038 

721.11774 ................................. 2070–0038 

721.11775 ................................. 2070–0038 

721.11776 ................................. 2070–0038 

* * * * * 

* * * * * 

PART 721—SIGNIFICANT NEW USES 

OF CHEMICAL SUBSTANCES 

■ 3. The authority citation for part 721 

continues to read as follows: 

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

2625(c). 

Subpart E—Significant New Uses for 

Specific Chemical Substances 

■ 4. Add §§ 721.11752 through 

721.11763 and 721.11765 through 

721.11776 in numerical order to subpart 

E to read as follows: 

Sec 

* * * * * 

721.11752 Quaternary ammonium salt of 

polyisobutene succinic acid (generic). 

721.11753 2-Propenoic acid, 2-alkyl-, 2- 

(dialkylamino)alkyl ester, polymer with 

.alpha.-(2-alkyl-1-oxo-2-alken-1-yl)- 

.omega.-methoxypoly(oxy-1,2- 

alkanediyl) (generic). 

721.11754 Alkanedioic acid, polymer with 

cycloalkyl dimethanol, alkyl and 

cycloalkyl diisocyanates, dimethylalkanediol, dihydroxyalkanoic acid 

methylenebis[isocyanatocyclohexane], 

hydroxyethyl acrylate- and polyalkyl 

glycol monoalkyl ether blocked (generic). 

721.11755 Poly(oxy-1,4-butanediyl), 

.alpha.-hydro-.omega.-hydroxy-, polymer 

with 1,1′-methylenebis[4- 

isocyanatobenzene], caprolactamblocked. 

721.11756 Tall-oil pitch, fraction, sterollow (generic). 

721.11757 Carboxylic acid, reaction 

products with metal hydroxide, 

inorganic dioxide and metal (generic). 

721.11758 Multi-walled carbon nanotubes; 

closed; 4.4–12.8 nm diameter; bundle 

length 10.6–211.1 mm; Grade: Jenotube 6. 

721.11759 Multi-walled carbon nanotubes; 

closed; 5.1–11.6 nm diameter; bundle 

length 1.9–552.0 mm; Grade: Jenotube 8. 

721.11760 Multi-walled carbon nanotubes; 

closed; 7.9–14.2 nm diameter; bundle 

length 9.4–106.4 mm; Grade: Jenotube 10. 

721.11761 Multi-walled carbon nanotubes; 

closed; 17.0–34.7 nm diameter; globular 

shape; Grade: Jenotube 20. 

721.11762 Nonanamide, N,N-dimethyl-. 

721.11763 2-Propenoic acid, 2-methyl, 2- 

(dimethylamino)ethyl ester, polymers 

with 2-(C16–18-acylamino)ethyl acrylate 

and hydroxyalkyl acrylate, acetates 

(generic). 

721.11765 2H-Pyran, tetrahydro-4-methyl. 

721.11766 Organic acid ester, polymer with 

aliphatic diols and 1,1′-methylenebis[4- 

isocyanatobenzene] (generic). 

721.11767 4,4-Methylenebis (2,6-dimethyl 

phenol) polymer with 2- 

(chloromethyl)oxirane, 1,4-benzenediol, 

2-methyl-2-propenoic acid, mixed alkyl 

substituted 2-methyl 2-propenoate, and 

ethyl 2-propenoate, reaction products 

with 2-(dimethylamino) ethanol 

(generic). 

721.11768 Phenol, methylethylidene, 

polymer chloromethyl epoxide and 

methylethylidene bis-oxy, bis-amine 

(generic). 

721.11769 Amine, 

methylethylidenebis(oxy) (generic). 

721.11770 Carbamic acid, N-[3- 

(trialkoxysilyl)propyl]-, C,C′-[2,2,4(or 

2,4,4)-trimethyl-1,6-hexanediyl] ester 

(generic). 

721.11771 Arylfurandione, 

[bis(trihaloalkyl)alkylidene]bis-, polymer 

with alkanediamine (generic). 

721.11772 Phosphonic acid, dimethyl ester, 

reaction products with alkyl-alkylalkanediol and alkanediol (generic). 

721.11773 Silane, halogenated (generic). 

721.11774 Heteromonocycle, polymer, 

substituted aliphatic carbamate, [2-[(1- 

oxo-2-propen-1-yl)oxy]alkyl]ester 

(generic). 


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721.11775 Alkanes, C4-8-branched and 

linear. 

721.11776 5H-1,2-Oxathiole, 2,2-dioxide. 

* * * * * 

§ 721.11752 Quaternary ammonium salt of 

polyisobutene succinic acid (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as quaternary ammonium 

salt of polyisobutene succinic acid 

(PMN P–16–349) 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)(3), (6)(vii) and (7), (b) and 

(c). 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)(ix), (2)(i) and (v), 

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

concentration is set at 1.0%. Alternative 

hazard and warning statements that 

meet the criteria of the Globally 

Harmonized System and OSHA Hazard 

Communication Standard may be used. 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(k). It is a 

significant new use to manufacture, 

process, or use the substance in any 

manner that results in inhalation 

exposure. It is a significant new use to 

use the substance in any consumer 

product to be added to gasoline or diesel 

fuels by the consumer. 

(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 and processors of this 

substance. 

(2) Limitation or revocation of certain 

notification requirements. The 

provisions of § 721.185 apply to this 

section. 

§ 721.11753 2-Propenoic acid, 2-alkyl-, 2- 

(dialkylamino)alkyl ester, polymer with 

.alpha.-(2-alkyl-1-oxo-2-alken-1-yl)-.omega.- 

methoxypoly(oxy-1,2-alkanediyl) (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as 2-propenoic acid, 2-alkyl-, 

2-(dialkylamino)alkyl ester, polymer 

with .alpha.-(2-alkyl-1-oxo-2-alken-1- 

yl)-.omega.-methoxypoly(oxy-1,2- 

alkanediyl) (PMN P–18–27) is subject to 

reporting under this section for the 

significant new uses described in 

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

requirements of this section do not 

apply to quantities of the substance after 

they have been completely reacted 

(cured) or when present as an impurity 

at less than 1% by weight. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(3) and (5) through (8), and 

(c). 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 or of at least 

1,000 during spray applications. 

(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: specific target 

organ toxicity; skin irritation; eye 

irritation; skin sensitization. Alternative 

hazard and warning statements that 

meet the criteria of the Globally 

Harmonized System and OSHA Hazard 

Communication Standard may be used. 

(iii) Industrial, commercial, and 

consumer activities. It is a significant 

new use to use the substance in 

formulations at greater than 0.1% for 

spray applications. 

(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. 

§ 721.11754 Alkanedioic acid, polymer 

with cycloalkyl dimethanol, alkyl and 

cycloalkyl diisocyanates, dimethylalkanediol, dihydroxyalkanoic acid 

methylenebis[isocyanatocyclohexane], 

hydroxyethyl acrylate- and polyalkyl glycol 

monoalkyl ether blocked (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as alkanedioic acid, polymer 

with cycloalkyl dimethanol, alkyl and 

cycloalkyl diisocyanates, dimethylalkanediol, dihydroxyalkanoic acid 

methylenebis[isocyanatocyclohexane], 

hydroxyethyl acrylate- and polyalkyl 

glycol monoalkyl ether blocked (PMN 

P–18–301) 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)(3) and (7), and (c). 

(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: skin irritation; 

skin sensitization; eye irritation; 

respiratory sensitization. Alternative 

hazard and warning statements that 

meet the criteria of the Globally 

Harmonized System and OSHA Hazard 

Communication Standard may be used. 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(o). 

(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. 

§ 721.11755 Poly(oxy-1,4-butanediyl), 

.alpha.-hydro-.omega.-hydroxy-, polymer 

with 1,1′-methylenebis[4- 

isocyanatobenzene], caprolactam-blocked. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

poly(oxy-1,4-butanediyl), .alpha.-hydro- 

.omega.-hydroxy-, polymer with 1,1′- 

methylenebis[4-isocyanatobenzene], 

caprolactam-blocked (P–18–340; CAS 

RN 2247074–17–3) is subject to 

reporting under this section for the 

significant new uses described in 

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

requirements of this section do not 

apply to quantities of the substance after 

they have been completely reacted 

(cured). 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(3) and (7), and (c). 

(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: respiratory 

sensitization; skin sensitization; 

reproductive toxicity; specific target 

organ toxicity. Alternative hazard and 

warning statements that meet the 

criteria of the Globally Harmonized 

System and OSHA Hazard 

Communication Standard may be used. 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(o). It is a 

significant new use to use the substance 

other than for one component thermoset 

elastomer manufacture. It is a significant 


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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 the substance 

without the use of a packed tower 

scrubber that removes at least 95 

percent of the substance prior to release. 

(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. 

§ 721.11756 Tall-oil pitch, fraction, sterollow (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as tall-oil pitch, fraction, 

sterol-low (PMN P–19–165) is subject to 

reporting under this section for the 

significant new uses described in 

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

requirements of this section do not 

apply to quantities of the substance after 

they have been completely reacted 

(cured). 

(2) The significant new uses are: 

(i) 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 (c), 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. 

§ 721.11757 Carboxylic acid, reaction 

products with metal hydroxide, inorganic 

dioxide and metal (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as carboxylic acid, reaction 

products with metal hydroxide, 

inorganic dioxide and metal (PMN P– 

20–10) is subject to reporting under this 

section for the significant new uses 

described in paragraph (a)(2) of this 

section. The requirements of this section 

do not apply to quantities of the 

substance after they have been 

completely reacted (cured). 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(3), (5), (6)(vii), (7) and (8), 

and (c). 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, or an APF 

of 50 if dust controls are implemented 

that demonstrate an exposure reduction 

of at least 30%. 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (d), (f), and (g)(1), (3)(iii) and 

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

substance may cause: skin sensitization; 

genetic toxicity; reproductive toxicity; 

specific target organ toxicity. 

Alternative hazard and warning 

statements that meet the criteria of the 

Globally Harmonized System and OSHA 

Hazard Communication Standard may 

be used. 

(iii) Release to water. Requirements as 

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

(c)(4), where N=11. 

(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. 

§ 721.11758 Multi-walled carbon 

nanotubes; closed; 4.4–12.8 nm diameter; 

bundle length 10.6–211.1 μm; Grade: 

Jenotube 6. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

multi-walled carbon nanotubes; closed; 

4.4–12.8 nm diameter; bundle length 

10.6–211.1 mm; Grade: Jenotube 6 (PMN 

P–20–62) 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 or 

incorporated into an article. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(3), (5), (6)(vii), (7) and (8), 

and (c). 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)(iii) and 

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

substance may cause: skin sensitization; 

eye irritation; respiratory sensitization; 

carcinogenicity; specific target organ 

toxicity. Alternative hazard and warning 

statements that meet the criteria of the 

Globally Harmonized System and OSHA 

Hazard Communication Standard may 

be used. 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

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

new use to manufacture the substance 

with a maximum weight percent of 

cobalt oxide impurity in excess of 2.1%. 

It is a significant new use to process or 

use the substance other than as an 

electrically conductive material, a heat 

dissipation material, a heat generation 

material, an additive for weight 

reduction, an additive to improve 

physical or mechanical properties, an 

additive in batteries, energy storage, and 

electrode applications, or an additive in 

field emission applications. It is a 

significant new use to process or use the 

substance in application methods that 

do not generate a vapor, mist, dust, or 

aerosol unless such an application 

method occurs in an enclosed process. 

(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. 

§ 721.11759 Multi-walled carbon 

nanotubes; closed; 5.1–11.6 nm diameter; 

bundle length 1.9–552.0 μm; Grade: 

Jenotube 8. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

multi-walled carbon nanotubes; closed; 

5.1–11.6 nm diameter; bundle length 

1.9–552.0 mm; Grade: Jenotube 8 (PMN 

P–20–63) 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 or 

incorporated into an article. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 


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§ 721.63(a)(3), (5), (6)(vii), (7) and (8), 

and (c). 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)(iii) and 

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

substance may cause: skin sensitization; 

eye irritation; respiratory sensitization; 

carcinogenicity; specific target organ 

toxicity. Alternative hazard and warning 

statements that meet the criteria of the 

Globally Harmonized System and OSHA 

Hazard Communication Standard may 

be used. 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

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

new use to manufacture the substance 

with a maximum weight percentage of 

cobalt oxide impurity in excess of 2.1%. 

It is a significant new use to process or 

use the substance other than as an 

electrically conductive material, a heat 

dissipation material, a heat generation 

material, an additive for weight 

reduction, an additive to improve 

physical or mechanical properties, an 

additive in batteries, energy storage, and 

electrode applications, or an additive in 

field emission applications. It is a 

significant new use to process or use the 

substance in application methods that 

do not generate a vapor, mist, dust, or 

aerosol unless such an application 

method occurs in an enclosed process. 

(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. 

§ 721.11760 Multi-walled carbon 

nanotubes; closed; 7.9–14.2 nm diameter; 

bundle length 9.4–106.4 μm; Grade: 

Jenotube 10. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

multi-walled carbon nanotubes; closed; 

7.9–14.2 nm diameter; bundle length 

9.4–106.4 mm; Grade: Jenotube 10 (PMN 

P–20–64) is subject to reporting under 

this section for the significant new uses 

described in paragraph (a)(2) of this 

section. The requirements of this section 

do not apply to quantities of the 

substance after they have been 

completely reacted or cured or 

incorporated into an article. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(3), (5), (6)(vii), (7) and (8), 

and (c). 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)(iii) and 

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

substance may cause: skin sensitization; 

eye irritation; respiratory sensitization; 

carcinogenicity; specific target organ 

toxicity. Alternative hazard and warning 

statements that meet the criteria of the 

Globally Harmonized System and OSHA 

Hazard Communication Standard may 

be used. 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

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

new use to manufacture the substance 

with a maximum weight percentage of 

cobalt oxide impurity in excess of 2.1%. 

It is a significant new use to process or 

use the substance other than as an 

electrically conductive material, a heat 

dissipation material, a heat generation 

material, an additive for weight 

reduction, an additive to improve 

physical or mechanical properties, an 

additive in batteries, energy storage, and 

electrode applications, or an additive in 

field emission applications. It is a 

significant new use to process or use the 

substance in application methods that 

do not generate a vapor, mist, dust, or 

aerosol unless such an application 

method occurs in an enclosed process. 

(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. 

§ 721.11761 Multi-walled carbon 

nanotubes; closed; 17.0–34.7 nm diameter; 

globular shape; Grade: Jenotube 20. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

multi-walled carbon nanotubes; closed; 

17.0–34.7 nm diameter; globular shape; 

Grade: Jenotube 20 (PMN P–20–65) is 

subject to reporting under this section 

for the significant new uses described in 

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

requirements of this section do not 

apply to quantities of the substance after 

they have been completely reacted or 

cured or incorporated into an article. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(3), (5), (6)(vii), (7) and (8), 

and (c). 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)(iii) and 

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

substance may cause: skin sensitization; 

eye irritation; respiratory sensitization; 

carcinogenicity; specific target organ 

toxicity. Alternative hazard and warning 

statements that meet the criteria of the 

Globally Harmonized System and OSHA 

Hazard Communication Standard may 

be used. 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

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

new use to manufacture the substance 

with a maximum weight percentage of 

cobalt oxide impurity in excess of 2.1%. 

It is a significant new use to process or 

use the substance other than as an 

electrically conductive material, a heat 

dissipation material, a heat generation 

material, an additive for weight 

reduction, an additive to improve 

physical or mechanical properties, an 

additive in batteries, energy storage, and 

electrode applications, or an additive in 

field emission applications. It is a 

significant new use to process or use the 

substance in application methods that 

do not generate a vapor, mist, dust, or 

aerosol unless such an application 

method occurs in an enclosed process. 

(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. 


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§ 721.11762 Nonanamide, N,N-dimethyl-. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

nonanamide, N,N-dimethyl- (PMN P– 

20–70; CAS RN 6225–08–7) is subject to 

reporting under this section for the 

significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(3), (5), (6)(v) and (vi), (7) and 

(8), (b), and (c). For purposes of 

§ 721.63(b), the concentration is set at 

1.0%. 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 (f), and (g)(1), (3)(iii) 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; 

reproductive toxicity; aspiration hazard. 

Alternative hazard and warning 

statements that meet the criteria of the 

Globally Harmonized System and OSHA 

Hazard Communication Standard may 

be used. 

(iii) Industrial, commercial, and 

consumer activities. It is a significant 

new use to use the substance other than 

as a solvent for use in formulated 

pesticide products. It is a significant 

new use to manufacture the substance 

other than by import into the United 

States (i.e., no domestic manufacture) 

using 20,000 kg International 

Organization for Standardization tank 

containers (ISOtainers) or 1,000 kg 

intermediate bulk containers (IBCs). 

(iv) Release to water. Requirements as 

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

(c)(4), where N=96. 

(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. 

§ 721.11763 2-Propenoic acid, 2-methyl, 2- 

(dimethylamino)ethyl ester, polymers with 

2-(C16–18-acylamino)ethyl acrylate and 

hydroxyalkyl acrylate, acetates (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as 2-propenoic acid, 2- 

methyl, 2-(dimethylamino)ethyl ester, 

polymers with 2-(C16–18- 

acylamino)ethyl acrylate and 

hydroxyalkyl acrylate, acetates (PMN P– 

20–84) is subject to reporting under this 

section for the significant new uses 

described in paragraph (a)(2) of this 

section. The requirements of this section 

do not apply to quantities of the 

substance after they have been 

completely reacted (cured). 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(3) and (7), (b), and (c). 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; specific target organ toxicity. 

Alternative hazard and warning 

statements that meet the criteria of the 

Globally Harmonized System and OSHA 

Hazard Communication Standard may 

be used. 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(o). It is a 

significant new use to process or use the 

substance in any manner that results in 

inhalation exposure. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

manufacturers, importers, and 

processors of this substance. 

(2) Limitation or revocation of certain 

notification requirements. The 

provisions of § 721.185 apply to this 

section. 

§ 721.11765 2H-Pyran, tetrahydro-4- 

methyl. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

2H-pyran, tetrahydro-4-methyl (PMN P– 

20–127; CAS RN 4717–96–8) 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)(3), (5), (6)(v) and (vi), (7) and 

(8), (b), and (c). For purposes of 

§ 721.63(a)(5), respirators must provide 

a National Institute for Occupational 

Safety and Health (NIOSH) assigned 

protection factor (APF) of at least 50. 

For purposes of § 721.63(b), the 

concentration is set at 1.0%. 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (f), and (g)(1), (3)(iii) 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 corrosion; 

serious eye damage; specific target organ 

toxicity; aspiration hazard. Alternative 

hazard and warning statements that 

meet the criteria of the Globally 

Harmonized System and OSHA Hazard 

Communication Standard may be used. 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(o). 

(iv) Release to water. Requirements as 

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

(c)(4), where N=540. 

(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. 

§ 721.11766 Organic acid ester, polymer 

with aliphatic diols and 1,1′-methylenebis[4- 

isocyanatobenzene] (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as organic acid ester, 

polymer with aliphatic diols and 1,1′- 

methylenebis[4-isocyanatobenzene] 

(PMN P–20–130) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. The requirements of this 

section do not apply to quantities of the 

substance after they have been 

completely reacted (cured). 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(3), (5), (6)(ix), (7) amd (8), 

and (c). 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) and (5). For 

purposes of § 721.72(g)(1), this 

substance may cause: acute toxicity; 

skin irritation; respiratory sensitization; 

skin sensitization; genetic toxicity; 


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carcinogenicity; reproductive toxicity; 

specific target organ toxicity. 

Alternative hazard and warning 

statements that meet the criteria of the 

Globally Harmonized System and OSHA 

Hazard Communication Standard may 

be used. 

(iii) Industrial, commercial, and 

consumer use. Requirements as 

specified in § 721.80(o). It is a 

significant new use to use the substance 

in any manner or method that involves 

spray application. 

(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. 

§ 721.11767 4,4-Methylenebis (2,6-dimethyl 

phenol) polymer with 2- 

(chloromethyl)oxirane, 1,4-benzenediol, 2- 

methyl-2-propenoic acid, mixed alkyl 

substituted 2-methyl 2-propenoate, and 

ethyl 2-propenoate, reaction products with 

2-(dimethylamino) ethanol (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as 4,4-methylenebis (2,6- 

dimethyl phenol) polymer with 2- 

(chloromethyl)oxirane, 1,4-benzenediol, 

2-methyl-2-propenoic acid, mixed alkyl 

substituted 2-methyl 2-propenoate, and 

ethyl 2-propenoate, reaction products 

with 2-(dimethylamino) ethanol (PMN 

P–21–3) is subject to reporting under 

this section for the significant new uses 

described in paragraph (a)(2) of this 

section. The requirements of this section 

do not apply to quantities of the 

substance after they have been 

completely reacted (cured). 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(3), (5), (6)(vii), (7) and (8), 

(b), and (c). 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(g)(1), this 

substance may cause: skin irritation; eye 

irritation. For purposes of § 721.72(e), 

the concentration is set at 1.0%. 

Alternative hazard and warning 

statements that meet the criteria of the 

Globally Harmonized System and OSHA 

Hazard Communication Standard may 

be used. 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(o). 

(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. 

§ 721.11768 Phenol, methylethylidene, 

polymer chloromethyl epoxide and 

methylethylidene bis-oxy, bis-amine 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as phenol, 

methylethylidene, polymer 

chloromethyl epoxide and 

methylethylidene bis-oxy, bis-amine 

(PMN P–21–28) 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)(3), (5), (6)(vii), (7) and (8), 

and (c). 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 in non-spray 

applications and 1,000 in spray 

applications. 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

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

For purposes of § 721.72(g)(1), this 

substance may cause: acute toxicity; 

skin corrosion; skin irritation; serious 

eye damage; eye irritation; respiratory 

sensitization; skin sensitization; specific 

target organ toxicity. Alternative hazard 

and warning statements that meet the 

criteria of the Globally Harmonized 

System and OSHA Hazard 

Communication Standard may be used. 

(iii) Release to water. Requirements as 

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

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

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (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. 

§ 721.11769 Amine, 

methylethylidenebis(oxy) (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as amine, 

methylethylidenebis(oxy) (generic) 

(PMN P–21–29) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. The requirements of this 

section do not apply to quantities of the 

substance after they have been 

completely reacted (cured). 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(3), (5), (6)(vii), (7) and (8), 

and (c). 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 in non-spray 

applications and 1,000 in spray 

applications. 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (d), (f), and (g)(1), (3)(iii) and 

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

substance may cause: acute toxicity; 

skin corrosion; skin irritation; serious 

eye damage; eye irritation; respiratory 

sensitization; skin sensitization; specific 

target organ toxicity. Alternative hazard 

and warning statements that meet the 

criteria of the Globally Harmonized 

System and OSHA Hazard 

Communication Standard may be used. 

(iii) Release to water. Requirements as 

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

(c)(4), where N=840. 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

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

applicable to manufacturers, importers, 

and processors of this substance. 

(2) Limitation or revocation of certain 

notification requirements. The 

provisions of § 721.185 apply to this 

section. 


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§ 721.11770 Carbamic acid, N-[3- 

(trialkoxysilyl)propyl]-, C,C′-[2,2,4(or 2,4,4)- 

trimethyl-1,6-hexanediyl] ester (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as carbamic acid, N-[3- 

(trialkoxysilyl)propyl]-, C,C′-[2,2,4(or 

2,4,4)-trimethyl-1,6-hexanediyl] ester 

(PMN P–21–34) 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 

completely reacted (cured). 

(2) The significant new uses are: 

(i) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (f), and (g)(1), (3)(iii) 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) Release to water. Requirements as 

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

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

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c), (f), 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. 

§ 721.11771 Arylfurandione, 

[bis(trihaloalkyl)alkylidene]bis-, polymer 

with alkanediamine (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as arylfurandione, 

[bis(trihaloalkyl)alkylidene]bis-, 

polymer with alkanediamine (PMN P– 

21–67) is subject to reporting under this 

section for the significant new uses 

described in paragraph (a)(2) of this 

section. The requirements of this section 

do not apply to quantities of the 

substance after they have been 

completely reacted, cured, or formed 

into an article. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(3) and (7), (b), and (c). For 

purposes of § 721.63(b), the 

concentration is set at 1.0%. 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

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

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

1.0%. For purposes of § 721.72(g)(1), 

this substance may cause: skin 

irritation; eye irritation; specific target 

organ toxicity. Alternative hazard and 

warning statements that meet the 

criteria of the Globally Harmonized 

System and OSHA Hazard 

Communication Standard may be used. 

(iii) Industrial, commercial, and 

consumer activities. It is a significant 

new use to manufacture or process the 

substance unless at a particle size of 10 

microns or greater. 

(iv) Disposal. It is a significant new 

use to dispose of the substance or waste 

streams containing the substance by 

incineration unless such incineration 

occurs at a minimum temperature of 870 

degrees Celsius. 

(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 (j) 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. 

§ 721.11772 Phosphonic acid, dimethyl 

ester, reaction products with alkyl-alkylalkanediol and alkanediol (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as phosphonic acid, 

dimethyl ester, reaction products with 

alkyl-alkyl-alkanediol and alkanediol 

(PMN P–21–93) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. The requirements of this 

section do not apply to quantities of the 

substance after they have been 

completely reacted (cured). 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(3) and (7), (b), and (c). 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)(iii) 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 corrosion; 

serious eye damage; eye irritation; 

reproductive toxicity; specific target 

organ toxicity. Alternative hazard and 

warning statements that meet the 

criteria of the Globally Harmonized 

System and OSHA Hazard 

Communication Standard may be used. 

(iii) Industrial, commercial, and 

consumer activities. It is a significant 

new use to manufacture, process, or use 

the substance in any manner that 

generates a dust, mist, particulate, or 

aerosol that results in inhalation 

exposure. It is a significant new use to 

use the substance in consumer products 

where the concentration of the 

substance equals or exceeds 3%. 

(iv) Release to water. Requirements as 

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

(c)(4), where N=180. 

(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. 

§ 721.11773 Silane, halogenated (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as silane, halogenated (PMN 

P–21–94) is subject to reporting under 

this section for the significant new uses 

described in paragraph (a)(2) of this 

section. The requirements of this section 

do not apply to quantities of the 

substance after they have been 

completely reacted (cured). 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(3), (5), (6)(vii), (7) and (8), 

(b), and (c). For purposes of § 721.63(b), 

the concentration is set at 1.0%. 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. 

(A) As an alternative to the respirator 

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

this section, a manufacture or processor 

may choose to follow the new chemical 

exposure limit (NCEL) provision listed 

in the TSCA Order for this substance. 

The NCEL is 0.05 mg/m3 as an 8-hour 

time weighted average. Persons who 

wish to pursue NCELs as an alternative 

to § 721.63 respirator requirements may 

request to do so under § 721.30. Persons 

whose § 721.30 requests to use the 

NCELs approach are approved by EPA 

will be required to follow NCELs 

provisions comparable to those 


khammond on DSKJM1Z7X2PROD with RULES
87358 Federal Register / Vol. 88, No. 241 / Monday, December 18, 2023 / Rules and Regulations 

contained in the corresponding TSCA 

Order. 

(B) [Reserved] 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (f), and (g)(1), (3)(iii) 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 corrosion; 

eye damage; specific target organ 

toxicity; pulmonary effects; 

developmental neurotoxicity. 

Alternative hazard and warning 

statements that meet the criteria of the 

Globally Harmonized System and OSHA 

Hazard Communication Standard may 

be used. 

(iii) Industrial, commercial, and 

consumer activities. It is a significant 

new use to use the substance other than 

as a deposition precursor for the 

manufacture of electronic components. 

(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. 

§ 721.11774 Heteromonocycle, polymer, 

substituted aliphatic carbamate, [2-[(1-oxo2-propen-1-yl)oxy]alkyl]ester (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as heteromonocycle, 

polymer, substituted aliphatic 

carbamate, [2-[(1-oxo-2-propen-1- 

yl)oxy]alkyl]ester (PMN P–21–115) 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)(3), (5), (6)(vii), (7) and (8), 

and (c). 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 or of at least 

1,000 during spray applications. 

(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: skin irritation; eye 

irritation; skin sensitization; respiratory 

sensitization. Alternative hazard and 

warning statements that meet the 

criteria of the Globally Harmonized 

System and OSHA Hazard 

Communication Standard may be used. 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(o). 

(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. 

§ 721.11775 Alkanes, C4–8-branched and 

linear. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

alkanes, C4–8-branched and linear 

(PMN P–21–141; CAS RN 2529890–37– 

5) is subject to reporting under this 

section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(3) and (7), (b), and (c). For 

purposes of § 721.63(b), the 

concentration is set at 0.1%. 

(ii) Hazard communication. 

Requirements as specified in 

§ 721.72(a). 

(iii) Industrial, commercial, and 

consumer activities. It is a significant 

new use to manufacture, process, or use 

the substance other than for use as a 

transportation fuel, refinery feedstock, 

or fuel blending additive. 

(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. 

§ 721.11776 5H–1,2-Oxathiole, 2,2-dioxide. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

5H–1,2-Oxathiole, 2,2-dioxide (PMN P– 

21–196; CAS RN 21806–61–1) is subject 

to reporting under this section for the 

significant new uses described in 

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

requirements of this section do not 

apply to quantities of the substance after 

they have been incorporated into an 

article. 

(2) The significant new uses are: 

(i) Protection in the workplace. 

Requirements as specified in 

§ 721.63(a)(3), (5), (6)(v) and (vi), (7) and 

(8), (b), and (c). 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 0.1%. 

(ii) Hazard communication. 

Requirements as specified in § 721.72(a) 

through (d), (f), and (g)(1), (3)(iii) and 

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

substance may cause: carcinogenicity, 

reproductive toxicity, skin sensitization; 

respiratory sensitization; genetic 

toxicity; specific target organ toxicity. 

Alternative hazard and warning 

statements that meet the criteria of the 

Globally Harmonized System and OSHA 

Hazard Communication Standard may 

be used. 

(iii) Industrial, commercial, and 

consumer activities. Requirements as 

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

new use to process or use the substance 

other than an enclosed system unless 

the worker personal protective 

equipment described in paragraph 

(a)(2)(i) is used. 

(iv) Disposal. Requirements as 

specified in § 721.85(b)(1) and (2), and 

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

to dispose of the substance by 

incineration unless the removal 

efficiency is at least 99.9%. 

(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 (j) 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. 2023–27653 Filed 12–15–23; 8:45 am] 

BILLING CODE 6560–50–P 


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