1822 Federal Register / Vol. 89, No. 8 / Thursday, January 11, 2024 / Rules and Regulations 

Agency Law Name/description CFR citation 

2023 2024 

Min penalty 

(rounded to 

nearest dollar) 

Max penalty 

(rounded to 

nearest 

dollar) 

Min penalty 

(rounded to 

nearest dollar) 

Max penalty 

(rounded to 

nearest 

dollar) 

OWCP .... Longshore and 

Harbor 

Workers’ 

Compensation Act.

Failure to report termination of payments.20 CFR 702.236 ..................... ........................ $345 ............ ........................ $356. 

OWCP .... Longshore and 

Harbor 

Workers’ 

Compensation Act.

Discrimination against employees 

who claim compensation or testify 

in a LHWCA proceeding.

20 CFR 702.271(a)(2) ............ 2,830 $14,149 ....... 2,922 $14,608. 

OWCP .... Black Lung 

Benefits Act.

Failure to report termination of payments.20 CFR 725.621 (d) ................ ........................ $1,724 ......... ........................ $1,780. 

OWCP .... Black Lung 

Benefits Act.

Failure to secure payment of benefits for mines with fewer than 25 

employees.

20 CFR 726.302(c)(2)(i) ......... 169 ..................... 174 

OWCP .... Black Lung 

Benefits Act.

Failure to secure payment of benefits for mines with 25–50 employees.20 CFR 726.302(c)(2)(i) ......... 335 ..................... 346 

OWCP .... Black Lung 

Benefits Act.

Failure to secure payment of benefits for mines with 51–100 employees.20 CFR 726.302(c)(2)(i) ......... 504 ..................... 520 

OWCP .... Black Lung 

Benefits Act.

Failure to secure payment of benefits for mines with more than 100 

employees.

20 CFR 726.302(c)(2)(i) ......... 670 ..................... 692 

OWCP .... Black Lung 

Benefits Act.

Failure to secure payment of benefits after 10th day of notice.20 CFR 726.302(c)(4) ............. 169 ..................... 174 

OWCP .... Black Lung 

Benefits Act.

Failure to secure payment of benefits for repeat offenders.20 CFR 726.302(c)(5) ............. 504 ..................... 520 

OWCP .... Black Lung 

Benefits Act.

Failure to secure payment of benefits.20 CFR 726.302(c)(5) ............. ........................ $3,446 ......... ........................ $3,558. 

[FR Doc. 2024–00253 Filed 1–10–24; 8:45 am] 

BILLING CODE 4510–HL–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 9 and 721 

[EPA–HQ–OPPT–2022–0867; FRL 9655–02– 

OCSPP] 

RIN 2070–AL10 

Per- and Poly-Fluoroalkyl Chemical 

Substances Designated as Inactive on 

the TSCA Inventory; Significant New 

Use Rule 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: Under the Toxic Substances 

Control Act (TSCA), EPA is finalizing a 

significant new use rule (SNUR) for 329 

per- and poly-fluoroalkyl substances 

(PFAS) that are designated as inactive 

on the TSCA Chemical Substance 

Inventory. PFAS are a group of 

chemicals that have been used in 

industry and consumer products since 

the 1940s because of their useful 

properties, such as water and stain 

resistance. Many PFAS break down very 

slowly and can build up in people, 

animals, and the environment over time. 

Exposure at certain levels to specific 

PFAS can adversely impact human 

health and other living things. Persons 

subject to the final SNUR are required 

to notify EPA at least 90 days before 

commencing any manufacture 

(including import) or processing of the 

chemical substance for a significant new 

use. Once EPA receives a notification, 

EPA must review and make an 

affirmative determination on the 

notification, and take such action as is 

required by any such determination 

before the manufacture (including 

import) or processing for the significant 

new use can commence. Such a review 

will assess whether the new use may 

present unreasonable risk to health or 

the environment and ensure that EPA 

takes appropriate action as required to 

protect health or the environment. 

DATES: This final rule is effective March 

11, 2024. For purposes of judicial 

review, this rule shall be promulgated at 

1 p.m. (EST) on January 25, 2024. 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPPT–2022–0867, 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) in Washington, 

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: 

Bethany Masten, Existing Chemicals 

Risk Management Division (7404M), 

Office of Pollution Prevention and 

Toxics, Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW, 

Washington, DC 20460–0001; telephone 

number: (202) 564–8803; email address: 

TSCA_PFAS@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. Does this action apply to me? 

You may be potentially affected by 

this action if you manufacture 

(including import), process, or 

distribute in commerce chemical 

substances and mixtures. 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: 

• NAICS 221210—Natural Gas 

Distribution; 

• NAICS 236220—Commercial and 

Institutional Building Construction; 


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Federal Register / Vol. 89, No. 8 / Thursday, January 11, 2024 / Rules and Regulations 1823 

• NAICS 324—Petroleum and Coal 

Product Manufacturing; 

• NAICS 324—Petroleum and Coal 

Product Manufacturing; 

• NAICS 32419—Petroleum 

Lubricating Oil and Grease 

Manufacturing; 

• NAICS 325—Chemical 

Manufacturing; 

• NAICS 325120—Industrial Gas 

Manufacturing; 

• NAICS 325180—Other Basic 

Inorganic Chemical Manufacturing; 

• NAICS 325199—All Other Basic 

Organic Chemical Manufacturing; 

• NAICS 325211—Plastics Material 

and Resin Manufacturing; 

• NAICS 325212—Synthetic Rubber 

Manufacturing; 

• NAICS 325220—Artificial and 

Synthetic Fibers and Filaments 

Manufacturing; 

• NAICS 325320—Pesticide and 

Other Agricultural Chemical 

Manufacturing; 

• NAICS 325411—Medicinal and 

Botanical Manufacturing; 

• NAICS 325412—Pharmaceutical 

Preparation Manufacturing; 

• NAICS 325612—Polish and Other 

Sanitation Good Manufacturing; 

• NAICS 325613—Surface Active 

Agent Manufacturing; 

• NAICS 325998—All Other 

Miscellaneous Chemical Product and 

Preparation Manufacturing; 

• NAICS 326113—Unlaminated 

Plastics Film and Sheet (except 

Packaging) Manufacturing; 

• NAICS 327910—Abrasive Product 

Manufacturing; 

• NAICS 333999—All Other 

Miscellaneous General Purpose 

Machinery Manufacturing; 

• NAICS 334511—Search, Detection, 

Navigation, Guidance, Aeronautical, 

and Nautical System and Instrument 

Manufacturing; 

• NAICS 336111—Automobile 

Manufacturing; 

• NAICS 423120—Motor Vehicle 

Supplies and New Parts Merchant 

Wholesalers; 

• NAICS 423420—Office Equipment 

Merchant Wholesalers; 

• NAICS 423510—Metal Service 

Centers and Other Metal Merchant 

Wholesalers; 

• NAICS 423740—Refrigeration 

Equipment and Supplies Merchant 

Wholesalers; 

• NAICS 423990—Other 

Miscellaneous Durable Goods Merchant 

Wholesalers; 

• NAICS 424690—Other Chemical 

and Allied Products Merchant 

Wholesalers; 

• NAICS 424720—Petroleum and 

Petroleum Products Merchant 

Wholesalers (except Bulk Stations and 

Terminals); 

• NAICS 424950—Paint, Varnish, and 

Supplies Merchant Wholesalers; 

• NAICS 441110—New Car Dealers; 

• NAICS 447190—Other Gasoline 

Stations; 

• NAICS 551112—Offices of Other 

Holding Companies; and 

• NAICS 562—Waste Management 

and Remediation Services. 

This action may also affect certain 

entities through pre-existing import, 

including import certification, and 

export notification rules under TSCA. 

Chemical importers are subject to the 

import provision of TSCA section 13 (15 

U.S.C. 2612), which requires that the 

Secretary of the Treasury ‘‘refuse entry 

into the customs territory of the United 

States’’ of any substance, mixture, or 

article containing a chemical substance 

or mixture that fails to comply with any 

rule issued under TSCA or that ‘‘is 

offered for entry in violation’’ of TSCA 

or certain rules or orders issued under 

TSCA, including rules issued under 

TSCA section 5. Persons who import 

any chemical substance in bulk form, as 

part of a mixture, or as part of an article 

(if required by rule) are also subject to 

TSCA section 13 import certification 

requirements and the corresponding 

regulations promulgated at 19 CFR 

12.118 through 12.127 (see also 19 CFR 

127.28). Chemical importers of the 

chemical substances in bulk form, as 

part of a mixture, or as part of an article 

(if required by rule) 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. The EPA policy in 

support of import certification appears 

at 40 CFR part 707, subpart B. 

In addition, pursuant to 40 CFR 

721.20, any persons who export or 

intend to export a chemical substance 

that is the subject of this final rule are 

subject to the export notification 

provisions of TSCA section 12(b) (15 

U.S.C. 2611(b)) and must comply with 

the export notification requirements in 

40 CFR part 707, subpart D. 

B. What is the Agency’s authority for 

taking this action? 

TSCA section 5(a)(2) (15 U.S.C. 

2604(a)(2)) authorizes EPA to determine 

that a use of a chemical substance is a 

‘‘significant new use.’’ EPA must make 

this determination by rule after 

considering all relevant factors, 

including those listed in TSCA section 

5(a)(2). Once EPA determines that a use 

of a chemical substance is a significant 

new use, TSCA section 5(a)(1) requires 

persons to submit a significant new use 

notice (SNUN) to EPA at least 90 days 

before they manufacture (including 

import) or process the chemical 

substance for that use (15 U.S.C. 

2604(a)(1)(B)(i)). TSCA further provides 

that such manufacturing (including 

import) or processing may not 

commence until EPA has conducted a 

review of the notice, made an 

appropriate determination on the notice, 

and taken such actions as are required 

in association with that determination 

(15 U.S.C. 2604(a)(1)(B)(ii)). As 

described in Unit V., the general SNUR 

provisions are found at 40 CFR part 721, 

subpart A. 

TSCA section 26(c) (15 U.S.C. 

2625(c)) authorizes EPA to take action 

under other sections of TSCA with 

respect to categories of chemical 

substances. 

C. What action is the Agency taking? 

This final SNUR will require persons 

to notify EPA at least 90 days before 

commencing any manufacture 

(including import) or processing of 

those 329 PFAS described in Unit II. 

that are designated as inactive on the 

TSCA Chemical Substance Inventory 

(TSCA Inventory) and that are not 

subject to an existing SNUR, including 

the existing SNURs cited at 40 CFR 

721.9582 and 721.10536, for any use. 

EPA is providing a list of the 299 

inactive PFAS that do not mask ‘‘fluor’’ 

or ‘‘fluorine’’ in the generic name in the 

public docket for this rule (Ref. 1). This 

category of PFAS chemical substances 

(‘‘inactive PFAS’’) is described further 

in Unit II. 

EPA is exempting from the notice 

requirement PFAS present as 

impurities, any byproducts which are 

not used for commercial purposes, and 

the importing or processing of inactive 

PFAS-containing articles because 

notification for the commercial activity 

designation (as active or inactive) on the 

TSCA Inventory is not required for such 

substances (see 40 CFR 710.27(a)). 

Similarly, EPA is exempting from the 

notice requirement PFAS manufactured 

or processed: in small quantities solely 

for research and development, for test 

marketing purposes, as a non-isolated 

intermediate, or solely for export from 

the United States as described in 40 CFR 

720.30(e) or 721.3, except where the 

Administrator has made a finding 

described in TSCA section 12(a)(2). 

The SNUR was proposed in the 

Federal Register on January 26, 2023 

(88 FR 4937 (FRL 9655–01–OCSPP)). 

EPA received a total of 20 public 

comment submissions in response to the 

notice. EPA received one ongoing use 

claim in Unit V. of the Response to 

Comments document (Ref. 2). EPA 


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reviewed the ongoing use claim, 

requested additional information, and 

has determined that the use is not 

ongoing, as described in Unit XI.D. 

D. Why is the Agency taking this action? 

As noted in the January 26, 2023, 

proposed rule (88 FR 4937 (FRL 9655– 

01–OCSPP)), this action is part of the 

comprehensive approach outlined in the 

Agency’s ‘‘PFAS Strategic Roadmap: 

EPA’s Commitments to Action 2021– 

2024’’ to proactively prevent PFAS from 

entering air, land, and water at levels 

that can adversely impact human health 

and the environment (Ref. 3). This 

SNUR is necessary to ensure that EPA 

receives timely advance notice of any 

future manufacturing (including import) 

or processing of inactive PFAS for new 

uses that may produce changes in 

human or environmental exposures. 

The rationale and objectives for this 

SNUR are further explained in Unit III. 

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 this rule. This 

analysis (Ref. 4), which is available in 

the docket, is discussed in Unit IX., and 

is briefly summarized here. 

In the event that a SNUN is 

submitted, costs are estimated to be 

approximately $26,894 per SNUN 

submission for large business submitters 

and $11,204 for small business 

submitters. In addition, 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, 

which is estimated to be approximately 

$43 per notification. 

II. Chemical Substances Subject to This 

Rule 

As discussed in Units II. and III. of the 

proposed rule (88 FR 4937, January 26, 

2023 (FRL 9655–01–OCSPP)), this 

SNUR applies to chemical substances 

designated as inactive on the TSCA 

Inventory that are also PFAS, except 

that inactive PFAS already subject to a 

significant new use rule, including but 

not limited to the significant new use 

rules cited at 40 CFR 721.9582 and 

721.10536, are not subject to notice 

requirements under this action to avoid 

potential redundancies or conflicts 

between the SNURs. 

For the purposes of this SNUR, the 

definition of ‘‘PFAS’’ includes 

chemicals that contain at least one of 

these three structures: 

• R-(CF2)-CF(R′)R′′, where both the 

CF2 and CF moieties are saturated 

carbons; 

• R-CF2OCF2-R′, where R and R′ can 

either be F, O, or saturated carbons; or 

• CF3C(CF3)R′R′′, where R′ and R′′ 

can either be F or saturated carbons. 

As described in Unit II. of the January 

26, 2023, proposed rule (88 FR 4937 

(FRL–9655–01–OCSPP)), this definition 

was developed to focus on substances 

most likely to be persistent in the 

environment and EPA notes that this 

definition may not be identical to other 

definitions of PFAS used within EPA or 

by other domestic or international 

organizations. 

The chemical substances for which 

EPA is finalizing a SNUR are the 329 

PFAS that are both currently designated 

as inactive on the TSCA Inventory and 

that are not subject to an existing SNUR. 

The specific chemical identities for 30 

of these substances that have been 

claimed as Confidential Business 

Information (CBI) have generic names 

(the nonconfidential substitute for the 

specific chemical name) that do not 

contain ‘‘fluor’’ or ‘‘fluorine.’’ EPA is 

providing a list of the 299 inactive PFAS 

that do not mask ‘‘fluor’’ or ‘‘fluorine’’ 

in the generic name in the public docket 

for this rule (Ref. 1). Because EPA is 

finalizing a structural definition of 

PFAS for this SNUR, EPA need not take 

additional steps to list the 30 inactive 

PFAS that are not subject to an existing 

SNUR and whose generic names do not 

contain ‘‘fluor’’ or ‘‘fluorine’’. 

On October 14, 2022, prior to the 

publication of the proposed SNUR, EPA 

received a Notice of Activity for CASRN 

306–92–3. This substance was 

erroneously included in the initial 

count and list of the 300 inactive PFAS 

that do not mask ‘‘fluor’’ or ‘‘fluorine’’ 

in the supplemental document, ‘‘List of 

Select Chemicals Subject to the 

Proposed Significant New Use Rule Perand Poly-fluoroalkyl Chemical 

Substances Designated as Inactive on 

the TSCA Inventory’’ (Ref. 5). The 

designation of this substance was 

‘‘active’’ at the time of the proposed rule 

and, as such, it is not subject to this 

final rule and the correct number of 

chemical substances for which EPA is 

finalizing a SNUR is 329. 

EPA received one Notice of Activity 

for CASRN 35101–47–7 on March 2, 

2023, after the publication of the 

proposed rule. As described in Unit IV 

of the proposed rule, uses arising after 

January 26, 2023, are significant new 

uses, and persons who began 

commercial manufacturing (including 

importing) or processing for a 

significant new use have to cease upon 

the effective date of the final rule. To 

resume their activities, these persons 

must first comply with all applicable 

SNUR notification requirements and 

wait until all TSCA prerequisites for the 

commencement of manufacturing 

(including importing) or processing 

have been satisfied. 

III. Rationale and Objectives 

A. What is the rationale for this action? 

As discussed in Units II. and III. of the 

proposed rule (88 FR 4937, January 26, 

2023 (FRL–9655–01–OCSPP)), PFAS 

can adversely impact human health and 

the environment. This final action is 

part of a comprehensive approach to 

proactively prevent PFAS from entering 

air, land, and water at levels that can 

adversely impact human health and the 

environment. 

In the absence of this final SNUR, 

manufacturing (including importing) or 

processing for the significant new uses 

in this rule could begin at any time after 

a manufacturer submits a Notice of 

Activity under section 8 of TSCA and 

the substance becomes ‘‘active’’ on the 

TSCA Inventory; EPA would not be 

provided prior notice under section 5 or 

an opportunity to review and address 

potential risks associated with the 

proposed new use. The manufacture 

(including import) or processing for any 

use of inactive PFAS would increase the 

magnitude and duration of exposure to 

humans and the environment to these 

chemicals. Given the concerns 

described in Units II. and III. of the 

proposed rule (88 FR 4937, January 26, 

2023 (FRL–9655–01–OCSPP)), EPA has 

determined that notification and EPA’s 

required review are warranted for these 

chemicals prior to their potential 

reintroduction into commerce. 

Consistent with EPA’s past practice 

for issuing SNURs under TSCA section 

5(a)(2), as described in Unit IV. of the 

proposed rule (88 FR 4937, January 26, 

2023 (FRL–9655–01–OCSPP)), EPA’s 

decision to issue a SNUR for a particular 

chemical use follows an analysis of the 

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

and need not be based on an extensive 

evaluation of the hazard, exposure, or 

potential risk associated with that use. 

If a person decides to begin 

manufacturing (including importing) or 

processing any of these chemicals for 

the significant new use, the notice to 

EPA allows the Agency to evaluate the 

new use according to the specific 

parameters and circumstances 

surrounding the conditions of use at the 

time it receives such a notification. 

B. What are the objectives of this action? 

Based on the considerations in Unit 

III.A., EPA will achieve the following 


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objectives with regard to the significant 

new use(s) of inactive PFAS that are 

designated in this rule: 

• EPA will receive notice of any 

person’s intent to manufacture 

(including import) or process the 

chemical substances for the described 

significant new use before that activity 

begins. 

• EPA will have an opportunity to 

review and evaluate information 

submitted in a SNUN before the notice 

submitter begins manufacturing 

(including importing) or processing the 

chemical substances for the described 

significant new use. 

• EPA must either determine that the 

significant new use is not likely to 

present an unreasonable risk of injury or 

take such regulatory action as is 

associated with an alternative 

determination under TSCA section 5 

before the manufacture or processing for 

the significant new use could 

commence. 

IV. Significant New Use Determination 

TSCA section 5(a)(2) states that EPA’s 

determination that a use of a chemical 

substance is a significant new use must 

be made after consideration of all 

relevant factors including: 

• The projected volume of 

manufacturing and processing of a 

chemical substance. 

• The extent to which a use changes 

the type or form of exposure of human 

beings or the environment to a chemical 

substance. 

• The extent to which a use increases 

the magnitude and duration of exposure 

of human beings or the environment to 

a chemical substance. 

• The reasonably anticipated manner 

and methods of manufacturing 

(including importing), processing, 

distribution in commerce, and disposal 

of a chemical substance. 

In addition to these factors 

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

statute authorizes EPA to consider any 

other relevant factors. 

To determine what constitutes a 

significant new use of an inactive PFAS, 

EPA considered relevant information 

about the toxicity or expected toxicity of 

these substances, likely human 

exposures and environmental releases 

associated with possible uses, and the 

four factors listed in TSCA section 

5(a)(2). Since the manufacture 

(including import) and processing of 

inactive PFAS has been discontinued in 

the United States, exposure will 

decrease over time. As such, EPA 

expects their presence in humans and 

the environment to decline over time. If 

any new uses of inactive PFAS were to 

resume after having been phased out, 

EPA believes that such uses could both 

change the type and form and increase 

the magnitude and duration of human 

and environmental exposure to the 

substances, constituting a significant 

new use. 

EPA acknowledges that the reporting 

of commercial activity under the TSCA 

Inventory Notification (Active-Inactive) 

Requirements Rule (‘‘Active-Inactive 

rule’’) was not required for several 

activities, including, but not limited to, 

importing or processing of inactive 

PFAS-containing articles, and 

manufacturing (including importing) or 

processing of inactive PFAS as 

impurities, byproducts not used for 

commercial purposes, small quantities 

solely for research and development, for 

test marketing purposes, as a nonisolated intermediate, or solely for 

export from the United States (Ref. 6). 

Thus, EPA has determined that the 

designation of these PFAS as inactive 

does not provide a sufficient basis to 

conclude that there are not ongoing uses 

of inactive PFAS for these activities, and 

because this SNUR is based on 

information obtained from the ActiveInactive rule, EPA is not at this time 

designating uses for these activities as 

significant new uses. Based on 

consideration of the statutory factors 

discussed herein, EPA has determined 

as significant new uses: manufacture 

(including import) or processing of 

inactive PFAS for any use except: 

(1) Importing or processing of inactive 

PFAS-containing articles; and/or 

(2) Manufacture (including import) or 

processing of inactive PFAS: 

• As impurities, 

• As byproducts not used for commercial 

purposes, 

• In small quantities solely for research 

and development, 

• For test marketing purposes, 

• For use as a non-isolated intermediate, or 

• Solely for export from the United States. 

V. Applicability of General Provisions 

General provisions for SNURs appear 

under 40 CFR part 721, subpart A. 

These provisions describe persons 

subject to the rule, recordkeeping 

requirements, exemptions to reporting 

requirements, and applicability of the 

rule to uses occurring before the 

effective date of the final rule. 

Provisions relating to user fees appear 

at 40 CFR part 700. According to 40 CFR 

721.1(c), persons subject to SNURs must 

comply with the same notice 

requirements and EPA regulatory 

procedures as submitters of Premanufacture Notices (PMNs) under 

TSCA section 5(a)(1)(A). In particular, 

these requirements include the 

information submission requirements of 

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

exemptions authorized by TSCA 

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

and the regulations at 40 CFR part 720. 

Once EPA receives a SNUN, EPA must 

either determine that the significant 

new use is not likely to present an 

unreasonable risk of injury or take such 

regulatory action as is associated with 

an alternative determination under 

TSCA section 5 before the 

manufacturing (including importing) or 

processing for the significant new use 

could commence. If EPA determines 

that the significant new 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 finding. 

Persons who export or intend to 

export a chemical substance identified 

in a proposed or final SNUR are subject 

to the export notification provisions of 

TSCA section 12(b). The regulations that 

interpret TSCA section 12(b) appear at 

40 CFR part 707, subpart D. Persons 

who import a chemical substance 

identified in a final SNUR are subject to 

TSCA section 13, which requires that 

the Secretary of the Treasury ‘‘refuse 

entry into the customs territory of the 

United States’’ of any substance, 

mixture, or article containing a chemical 

substance or mixture that fails to 

comply with any rule issued under 

TSCA or that ‘‘is offered for entry in 

violation’’ of TSCA or certain rules or 

orders issued under TSCA, including 

SNURs issued under TSCA section 5. 

Persons who import any chemical 

substance in bulk form, as part of a 

mixture, or as part of an article (if 

required by rule) are also subject to 

TSCA section 13 import certification 

requirements, codified at 19 CFR 12.118 

through 12.127; see also 19 CFR 127.28. 

Those persons must certify that the 

shipment of the chemical substance 

complies with all applicable rules and 

orders under TSCA, including any 

SNUR requirements. The EPA policy in 

support of import certification appears 

at 40 CFR part 707, subpart B. 

VI. Applicability of Rule to Uses 

Occurring Before Effective Date of the 

Final Rule 

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. This rule was proposed on January 

26, 2023 (88 FR 4937 (FRL–9655–01– 

OCSPP)). Uses arising after the 

publication of the proposed rule are 


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1826 Federal Register / Vol. 89, No. 8 / Thursday, January 11, 2024 / Rules and Regulations 

distinguished from uses that existed at 

publication of the proposed rule. The 

former would be new uses, the latter 

ongoing uses, except that uses that are 

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. EPA 

solicited public comment to identify 

any ongoing manufacturing or 

processing of inactive PFAS subject to 

the proposed SNUR. EPA received one 

ongoing use claim captured in the 

Response to Comments in Unit V. (Ref. 

2). EPA reviewed the ongoing use claim, 

requested additional information, and 

has determined that the use is not 

ongoing, as described in Unit XI.D. 

Persons who began commercial 

manufacturing (including importing) or 

processing of the chemical substances 

for a significant new use identified as of 

January 26, 2023, must cease any such 

activity upon the effective date of this 

final rule. To resume their activities, 

these persons first have to comply with 

all applicable SNUR notification 

requirements and wait until all TSCA 

prerequisites for the commencement of 

manufacturing (including importing) or 

processing have been satisfied. Consult 

the Federal Register document of April 

24, 1990 (55 FR 17376 (FRL–3658–5)) 

for a more detailed discussion of the 

cutoff date for ongoing uses. 

VII. Development and Submission of 

Information 

EPA recognizes that TSCA section 5 

does not usually require developing 

new information (e.g., generating test 

data) before submission of a SNUN. 

There is an exception: development of 

information is required where the 

chemical substance subject to the SNUR 

is also subject to a rule, order, or 

consent agreement under TSCA section 

4 (see TSCA section 5(b)(1)). 

In the absence of a TSCA section 4 

test rule or order covering the chemical 

substance, persons are required to 

submit only information in their 

possession or control and to describe 

any other information known to or 

reasonably ascertainable by them (15 

U.S.C. 2604(d); 40 CFR 721.25 and 

720.50). However, as a general matter, 

EPA recommends that SNUN submitters 

include information that would permit 

a reasoned evaluation of risks posed by 

the chemical substance during its 

manufacture (including import), 

processing, distribution in commerce, 

use, or disposal. Potentially useful 

information includes physical-chemical 

property data and any information 

related to persistence, bioaccumulation, 

toxicity, and other characteristics that 

may help predict the impact of a 

chemical substance on health or the 

environment. 

Submitting a SNUN that does not 

include information sufficient to permit 

a reasoned evaluation may increase the 

likelihood that EPA will either respond 

with a determination that the 

information available to the Agency is 

insufficient to permit a reasoned 

evaluation of the health and 

environmental effects of the significant 

new use or, alternatively, that in the 

absence of sufficient information, the 

manufacture, processing, distribution in 

commerce, use, or disposal of the 

chemical substance may present an 

unreasonable risk of injury. 

SNUN submitters should be aware 

that EPA will be better able to evaluate 

SNUNs and define the terms of any 

potentially necessary controls if the 

submitter provides detailed information 

on human exposure and environmental 

releases that may result from the 

significant new use of the chemical 

substances. 

VIII. SNUN Submissions 

EPA recommends that submitters 

consult with the Agency prior to 

submitting a SNUN to discuss what 

information may be useful in evaluating 

a significant new use notice. 

Discussions with the Agency prior to 

submission can afford ample time to 

conduct any tests that might be helpful 

in evaluating risks posed by the 

substance. According to 40 CFR 

721.1(c), persons submitting a SNUN 

must comply with the same notice 

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 721.25 and 720.40. E– 

PMN software is available electronically 

at https://www.epa.gov/chemicalsunder-tsca. 

IX. Economic Analysis 

A. What is the analysis for SNUNs? 

EPA has evaluated the potential costs 

of establishing SNUR reporting 

requirements for potential 

manufacturers (including importers) 

and processors of the chemical 

substances included in this rule (Ref. 4). 

In the event that a SNUN is submitted, 

costs are estimated at approximately 

$26,894 per SNUN submission for large 

business submitters and $11,204 for 

small business submitters. These 

estimates include the cost to prepare 

and submit the SNUN, 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(b)(2)(iii), or, if they are a small 

business as defined at 13 CFR 121.201, 

a reduced user fee of $3,330 (40 CFR 

700.45(b)(1)). Additionally, these 

estimates reflect the costs and fees as 

they are known at the time this rule is 

promulgated. EPA’s complete economic 

analysis is available in the public docket 

for this rule (Ref. 4). 

B. What is the analysis for export 

notifications? 

Under TSCA section 12(b) and the 

implementing regulations at 40 CFR part 

707, subpart D, exporters must notify 

EPA if they export or intend to export 

a chemical substance or mixture for 

which, among other things, a rule has 

been proposed or promulgated under 

TSCA section 5. 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 chemicals 

covered in this SNUR, as stated in the 

accompanying economic analysis of this 

SNUR, the estimated cost of the export 

notification requirement on a per unit 

basis is approximately $43. 

X. Scientific Standards, Evidence, and 

Available Information 

EPA has used scientific information, 

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). As 

noted in Unit III., EPA’s decision to 

promulgate a SNUR for a particular 

chemical use need not be based on an 

extensive evaluation of the hazard, 

exposure, or potential risk associated 

with that use. 

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 this SNUR, in Unit II. of 

the January 26, 2023, proposed rule (88 

FR 4937 (FRL–9655–01–OCSPP)), and 

in the references cited throughout the 

preamble of the proposed rule. EPA 


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recognizes, based on the available 

information, that there is variability and 

uncertainty in whether any particular 

significant new use would actually 

present an unreasonable risk. For 

precisely this reason, it is appropriate to 

secure a future notice and review 

process for these uses, at such time as 

they are known more definitely. 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. 

XI. Response to Public Comment 

The Agency reviewed and considered 

all comments received related to the 

January 26, 2023, proposed rule (88 FR 

4937 (FRL–9655–01–OCSPP)). Copies of 

all comments are available in the docket 

for this action (EPA–HQ–OPPT–2022– 

0867), and EPA responses are in the 

Response to Comments document (Ref. 

2), which is also available in the docket. 

Several primary comment topics 

included: the Agency’s statutory 

authority; the definition of PFAS; 

significant new uses; ongoing 

manufacturing and processing; chemical 

identity claimed as CBI; byproducts, 

impurities, and non-isolated 

intermediates; and costs and fees of 

SNUN submissions which are 

summarized in this unit, along with 

EPA responses. 

1. Comment: Several commenters 

stated that EPA is acting within its 

authority under TSCA with the 

proposed SNUR. Other commenters 

commented that EPA is acting outside of 

its statutory authority and one 

commenter claimed that the inactive 

status of a chemical or chemicals on the 

TSCA Inventory should not be used as 

the sole basis for a SNUR and that the 

proposal appears to undercut the simple 

notification procedure for changing the 

status of a chemical substance from 

inactive to active that Congress included 

when TSCA was amended. One 

commenter stated that Congress did not 

include in the 2016 amendments a 

provision that requires any form of 

substantive review of substances prior 

to change of status from inactive to 

active. The same commenter stated that 

EPA appears not to have undertaken a 

chemical-by-chemical review for the 

three hundred substances subject to this 

SNUR, and findings on a chemicalspecific basis have not been provided. 

Response: EPA disagrees that this 

SNUR, issued pursuant to TSCA section 

5(a) undercuts the notification 

procedure established under TSCA 

section 8(b). TSCA section 8(b)(5)(B)(i) 

requires that ‘‘[a]ny person that intends 

to manufacture or process for a 

nonexempt commercial purpose a 

chemical substance that is designated as 

an inactive substance shall notify the 

Administrator before the date on which 

the inactive substance is manufactured 

or processed.’’ This Notice of Activity 

reporting requirement applies to all 

chemical substances designated as 

inactive, including those subject to this 

SNUR. EPA separately has authority 

under TSCA section 5(a) to determine 

that uses of a chemical substance (or 

category of chemical substances) are 

‘‘significant new uses’’ for which 

notification to EPA is required before 

manufacture (including import) or 

processing for the significant new use 

can commence. EPA has authority 

under TSCA section 5(a) to promulgate 

SNURs for ‘‘any chemical substance,’’ 

without regard to whether the chemical 

substance is designated as active or 

inactive. There is also no requirement 

that EPA need undertake a chemical-bychemical review as the commenter 

suggests. One common characteristic of 

concern of PFAS is that many break 

down very slowly and can build up in 

people, animals, and the environment 

over time (Ref. 7). As described in Unit 

IV. of the January 26, 2023, proposed 

rule (88 FR 4639 (FRL–9655–01– 

OCSPP)), the baseline projected volume 

for these 329 inactive PFAS is presumed 

to be minimal based on their inactive 

TSCA Inventory designation. As such, 

any new manufacturing or processing of 

any of these chemical substances would 

significantly change the production 

volume and produce changes in human 

or environmental exposures to these 

chemical substances. Thus, EPA has 

determined it is necessary to review and 

make an affirmative determination on 

potential risks of the chemical 

substances under section 5 before the 

manufacture (including import) or 

processing of the chemical substances 

for the described significant new use 

could begin. 

2. Comment: Many commenters 

discussed the proposed definition of 

PFAS for this rule. Several commenters 

suggested that EPA identify covered 

PFAS by specific identification rather 

than through a structural definition. 

One commenter stated that structural 

definitions are difficult to use as they 

require an extensive understanding of 

the often-complex chemistry of PFAS, 

and structural definitions may also be 

ambiguous and over-inclusive. Other 

commenters stated that should EPA 

move ahead with a broad definition and 

stated that the definition should be 

consistent with the definition of PFAS 

the Agency uses in other regulations, or 

that EPA should work with Federal 

partners to ensure a consistent Federal 

definition of PFAS. Two commenters 

stated that EPA should adopt a 

definition of PFAS that more closely 

aligns with the Organization for 

Economic Co-operation and 

Development’s (OECD) broad definition 

(Ref. 8). 

Response: EPA believes it has been 

chemically precise in the proposed 

structural definition and appreciates 

that there are differences between the 

definition of PFAS used for this rule, for 

other actions in the Agency, and by 

other Federal agencies. The Agency 

considered adopting various definitions, 

including some of those suggested by 

commenters, but ultimately determined 

those definitions were not appropriate 

for this rule because they were not 

developed to focus on substances most 

likely to be persistent in the 

environment while excluding those 

substances that are ‘‘lightly’’ 

fluorinated. In reaching this decision, 

EPA considered that OECD also 

stipulates that there may be different 

definitions of ‘‘PFAS’’ for different 

entities or for different purposes, and 

that it may be appropriate for there to 

be different definitions or 

interpretations depending on the 

specific scenario. The proposed 

definition focused on substances with 

greater potential for exposures to people 

and/or the environment and by 

extension more potential to present 

risks. Adopting the OECD definition of 

PFAS for this rule would have included 

many substances whose only fluorine 

molecule is in a terminal -CF3 and that 

do not share a structure that is likely to 

result in the substance’s persistence in 

the environment, or which would 

degrade to a substance that shares 

toxicological or physiochemical 

properties with perfluorooctanoic acid 

(PFOA), perfluorooctanesulfonic acid 

(PFOS), or GenX (Ref. 9). 

EPA disagrees that the scope of 

substances subject to notification 

requirements should be a discrete list 

and not a structural definition. EPA 

points out that other regulations 

promulgated pursuant to TSCA have 

relied on a structural definition when 

appropriate (e.g., the long-chain 

perfluoroalkyl carboxylate (LCPFAC) 

SNUR defines covered substances using 

a structural definition (40 CFR 

721.10536), and the polymer exemption 

rule for new chemical PMNs defines 

covered PFAS polymers using structural 

definitions (40 CFR 723.250)). 

Additionally, there are PFAS on the 

TSCA Inventory whose generic names 


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do not clearly state the substance is 

fluorinated (i.e., no ‘‘fluor’’ included in 

the generic name). The inclusion of 

those chemicals on a discrete list for 

reporting under this rule would disclose 

structural information for these 

substances that has been claimed as CBI. 

EPA is finalizing the rule as proposed 

and is providing the list of the 299 

inactive PFAS that do not mask ‘‘fluor’’ 

or ‘‘fluorine’’ in the generic name in the 

public docket for this rule. EPA believes 

that providing a list of the 299 PFAS 

should eliminate most ambiguity, and 

notes that an entity with a valid 

commercial need for EPA to verify if a 

substance is on the inventory can 

submit a Bona Fide Intent to 

Manufacture or Import Notice (‘‘bona 

fide notice’’). EPA will consider the 

information submitted in a bona fide 

notice and, if the Agency believes that 

the submitter has demonstrated a 

genuine intent to manufacture or 

import, search the full TSCA Inventory 

master file and provide a written 

determination to the submitter on the 

TSCA Inventory status (including SNUR 

status) for the requested chemical 

substance. 

3. Comment: Several commenters 

stated that SNURs are intended to 

address truly new uses. The 

commenters state that the dormant 

status of a substance on the TSCA 

Inventory does not mean that a previous 

use should be considered new when 

reintroduced into commerce. Two 

commenters stated that under TSCA, 

EPA is required to evaluate a substance 

prior to promulgating a SNUR. One 

commenter suggested that EPA 

specifically exclude from the 

notification requirements any uses that 

were identified to EPA in previously 

submitted PMNs. Another commenter 

said that addressing the discontinued 

use of an existing chemical with a 

SNUR is only administratively efficient 

where other requirements of TSCA 

section 5 have been met and where (1) 

stakeholder groups are broadly aware of 

the proposal and (2) agree with EPA that 

the use is permanently discontinued or 

being phased out; the commenter stated 

that these elements have not been met. 

Response: EPA disagrees that the 

previous use of a chemical substance 

listed as inactive on the TSCA Inventory 

should not be considered new when 

such use is restarted. TSCA section 5 

gives EPA the authority to designate 

uses of a chemical as Significant New 

Uses, including but not limited to uses 

that were ongoing in the past but are not 

longer in process. Part of EPA’s 

rationale for promulgating this SNUR is 

that the chemical substances subject to 

this SNUR are considered to be PFAS. 

Certain PFAS are associated with risk to 

human health and the environment, and 

one common characteristic of concern of 

PFAS is that many break down very 

slowly and can build up in people, 

animals, and the environment over time. 

Therefore, EPA has determined that any 

use of these PFAS would produce 

changes in human or environmental 

exposures and should trigger a SNUN 

and accompanying EPA review and 

action as necessary. EPA also disagrees 

in part with the commenter who 

suggested that EPA specifically exclude 

from the SNUN requirements any uses 

that were identified to EPA in 

previously submitted PMNs. However, 

uses of chemical substances for which a 

PMN has been submitted (and for which 

EPA has reasonably available 

information that such uses are ongoing) 

are considered ongoing uses for which 

the SNUR does not apply. If production 

of a chemical has ceased, the use of the 

chemical substance is not considered to 

be ongoing and such use is covered by 

this SNUR. 

EPA required reporting (with certain 

exemptions from reporting at 40 CFR 

710.27(a)) under the Active-Inactive 

reporting rule of each chemical 

substance manufactured (including 

imported) or processed in the U.S. over 

a 10-year period ending on June 21, 

2016, and there was no manufacturing 

(including import), or processing 

reported for these inactive PFAS (Ref. 

6). EPA believes the comment period for 

the proposed SNUR allowed for 

stakeholder groups to be broadly aware 

of the proposal notice and provided an 

additional opportunity for industry to 

provide specific documentation of the 

status of each chemical. EPA received 

one ongoing use claim and has 

determined that the use is not ongoing, 

as described in Unit XI.D. 

4. Comment: An anonymous 

submitter notified EPA that it intends to 

manufacture a PFAS covered by the 

proposed SNUR. The commenter stated 

that since EPA is not authorized under 

TSCA to adopt a SNUR for an ongoing 

use, it should exclude this substance 

from the final SNUR. 

Response: EPA investigated the 

confidentially submitted information 

and determined that the manufacture of 

this substance is not ongoing. EPA is 

therefore not excluding the manufacture 

of this substance from the final SNUR. 

5. Comment: Several commenters 

provided feedback on the options 

described in the proposed rule for 

potential further agency action to list 

out in the regulation either the specific 

chemical identity or generic name of all 

of the chemicals that fall within the 

scope of the proposed SNUR. Some 

commenters stated that EPA must 

identify all substances for which the 

chemical identity has been claimed as 

CBI, regardless as to whether ‘‘fluor’’ or 

‘‘fluorine’’ appears in the name. Another 

commenter stated that TSCA section 

14(d)(3) allows information claimed as 

CBI to be disclosed if the Agency 

determines that disclosure is ‘‘necessary 

to protect health or the environment 

against an unreasonable risk of injury to 

health or the environment.’’ Thus, the 

commenter stated that EPA should 

override CBI claims in the context of 

this proposed SNUR and identify those 

PFAS whose generic names do not 

include ‘‘fluor’’ or ‘‘fluorine’’. The 

commenter concluded that since these 

PFAS are inactive, any business interest 

in their confidentiality is minimal and 

overridden by the need of states and the 

public for the information. Another 

commenter stated that although EPA 

must maintain substantiated CBI claims 

for these substances, EPA can include 

the generic names and PMN and 

accession numbers, which are not CBI, 

which will minimize the potential for 

confusion about whether certain 

substances are subject to this proposal. 

Another commenter stated that EPA 

should use its authority under TSCA 

section 14(f) to require re-substantiation 

of and review the chemical identity CBI 

claims for these PFAS. Additionally, the 

commenter stated that EPA should 

initiate review of the remaining specific 

chemical identity CBI claims to ensure 

they comply with TSCA section 14. 

Another commenter relinquished its CBI 

claims for the specific chemical 

identities for twelve substances listed in 

the confidential portion of the TSCA 

Inventory that EPA has identified as 

being subject to the proposed SNUR and 

requested that EPA move them to the 

public portion of the TSCA Inventory. 

Response: EPA disagrees that all 

substances for which the chemical 

identity has been claimed as CBI must 

be identified. Under section 14(c) of 

TSCA, submitters may claim 

information submitted to EPA under 

TSCA as CBI. The listing of a chemical 

substance as ‘‘inactive’’ on the TSCA 

inventory does not itself impact CBI 

claims relating to such chemical 

substance, including CBI claims relating 

to the structure or chemical identity of 

a chemical substance. Further, as 

explained previously, EPA is finalizing 

a structural definition of the chemical 

substances subject to this SNUR, and 

EPA believes that persons will be able 

to identify PFAS subject to this SNUR 

based on that structural definition, 

regardless of whether there is a 

universally known unique identifier. 


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For additional convenience, EPA is 

providing a list of the inactive PFAS 

that do not mask ‘‘fluor’’ or ‘‘fluorine’’ 

in the generic name in the public docket 

for this rule. 

EPA disagrees that its conclusions 

pursuant to section 5 of TSCA 

supporting the proposed SNUR for these 

substances meet the very different 

conclusions that would prompt 

mandatory CBI review in accordance 

with section 14(f). The fact that the 

substances are currently designated as 

inactive following reporting under 

section 8(b) of TSCA does not mean that 

the substance identities are no longer 

treated as confidential by the original 

CBI claimant or by subsequent or 

prospective manufacturers, and 

therefore EPA has not determined that 

the status of a substance as inactive on 

the TSCA inventory is a ‘‘reasonable 

basis to believe’’ that chemical identity 

information about such substance ‘‘does 

not qualify’’ for CBI protection, as is 

required by TSCA section 14(f)(2)(B). 

Further, CBI claims asserted prior to the 

enactment of the Lautenberg 

amendments to TSCA in 2016 do not 

automatically expire as do most postLautenberg CBI claims. However, if a 

SNUN on any of these substances is 

submitted, EPA would review any 

renewed CBI claim for chemical identity 

at that time, in accordance with the 

requirements of TSCA section 14(g). 

Submitters of such SNUNs that assert a 

CBI claim for chemical identity should 

expect that if the generic name 

submitted with such a claim does not 

identify the substance as a PFAS, EPA 

expects to require revision of the generic 

name to meet the generic name 

requirements in TSCA section 14(c). 

Finally, the request that EPA initiate 

review of the remaining specific 

chemical identity CBI claims to ensure 

they comply with TSCA section 14 is 

outside the scope of this rulemaking. 

EPA acknowledges the commenter 

who relinquished its CBI claims for the 

specific chemical identities and plans to 

move the twelve substances into the 

public portion of the TSCA Inventory. 

6. Comment: Many commenters stated 

that requiring reporting on the 

manufacture of any substances that were 

exempt under the Active-Inactive Rule 

would not be appropriate, including 

substances manufactured and processed 

solely for export or test marketing, nonisolated intermediates, and all other 

exemptions from PMN requirements 

listed at 40 CFR 720.30(h) (Ref. 6). Other 

commenters expressed opposition to the 

proposed exemptions. One commenter 

stated that exposure to minuscule 

amounts of PFAS is a threat to human 

health and safety, and the 

reintroduction of inactive PFAS, in even 

the smallest quantities, should therefore 

be subject to the same intense health 

and safety review as other quantities of 

PFAS. One commenter urged EPA to 

finalize the rule without regulatory 

exemptions and extend the proposed 

SNUR to byproducts because they are 

significant sources of PFAS exposure 

and environmental releases. 

Response: EPA acknowledges that the 

standard SNUR exemptions do not fully 

align with the Active-Inactive reporting 

exemptions. In the final rule, EPA is 

adding an exemption for non-isolated 

intermediates and expanding the 

exemption for byproducts for 

consistency with the PMN exemptions 

at 40 CFR 720.30(g) and (h)(2) and 

believes that these exemptions are now 

consistent with the exemptions from 

Active-Inactive reporting. As EPA 

collects evidence of the use of PFAS, 

potentially including inactive PFAS, 

EPA may consider making certain 

exemptions inapplicable in the future. 

The Agency expects to receive 

additional information about any 

ongoing use of PFAS as part of the 

separate TSCA section 8(a)(7) PFAS 

reporting rule that was proposed on 

June 28, 2021 (86 FR 33962 (FRL–7902– 

01–OCSPP)) and finalized on October 

11, 2023 (88 FR 70516 (FRL 7902–02– 

OCSPP)). 

7. Comment: One commenter stated 

that the proposal incorrectly estimated 

the costs related to the submission of a 

SNUN. The commenter said that the 

estimated cost of $26,737 is inconsistent 

with the Agency’s latest proposal for 

increasing TSCA fees. Another 

commenter stated that while the user fee 

may discourage a manufacturer from 

using PFAS in a significant way, it is 

likely that the user fee will deter users 

from submitting a SNUN altogether. 

Response: EPA disagrees that the 

proposal incorrectly estimated the costs 

related to the submission of a SNUN, 

and notes that the latest proposal for 

TSCA fees referenced by the commenter 

has not been finalized. EPA disagrees 

with the commenter that a user fee 

would encourage a manufacturer to 

circumvent the SNUR. EPA has 

enforcement mechanisms in place to 

ensure compliance with EPA 

regulations. 

XII. References 

The following is a listing of the 

documents that are specifically 

referenced in this document. The docket 

includes these documents and other 

information considered by EPA, 

including documents that are referenced 

within the documents that are included 

in the docket, even if the referenced 

document is not physically located in 

the docket. For assistance in locating 

these other documents, please consult 

the technical person listed under FOR

FURTHER INFORMATION CONTACT. 

1. U.S. EPA. ‘‘List of Select Chemicals 

Subject to the Proposed Significant New 

Use Rule Per- and Poly-fluoroalkyl 

Chemical Substances Designated as 

Inactive on the TSCA Inventory.’’ 

October 2022. 

2. U.S. EPA. ‘‘Response to Comments on the 

Final Per- and Poly-fluoroalkyl Chemical 

Substances Designated as Inactive on the 

TSCA Inventory Significant New Use 

Rule (SNUR).’’ October 2023. 

3. U.S. EPA. ‘‘PFAS Strategic Roadmap: 

EPA’s Commitment to Action 2021– 

2024.’’ EPA–100–K–21–002, October 

2021. 

4. U.S. EPA. ‘‘Economic Analysis of the Final 

Significant New Use Rule Per- and Polyfluoroalkyl Chemical Substances 

Designated as Inactive on the TSCA 

Inventory.’’ October 2023. 

5. U.S. EPA. ‘‘List of Select Chemicals 

Subject to the Proposed Significant New 

Use Rule Per- and Poly-fluoroalkyl 

Chemical Substances Designated as 

Inactive on the TSCA Inventory.’’ 

January 2022. 

6. U.S. EPA. TSCA Inventory Notification 

(Active-Inactive) Requirements; Final 

Rule, 82 FR 37520 (FRL–9964–22), 

August 11, 2017. 

7. Evich, Marina G., Davis, Mary J.B., 

McCord, James P., Acrey, Brad, 

Awkerman, Jill A., Knappe, Detlef R.U., 

Lindstrom, Andrew B., Speth, Thomas 

F., Tebes-Stevens, Caroline, Strynar, 

Mark J., Wang, Zhanyun, Weber, Eric J., 

Henderson, Matthew W., Washington, 

John W. Per- and polyfluoroalkyl 

substances in the environment. Science. 

375: 6580, 1–14. February 4, 2022 

8. Organisation for Economic Co-operation 

and Development (OECD). ‘‘Reconciling 

Terminology of the Universe of Per- and 

Polyfluoroalkyl Substances: 

Recommendations and Practical 

Guidance.’’ July 9, 2021. 

9. United Nations Environment Programme. 

Sources, Fates, Toxicity, and Risks of 

Trifluoroacetic Acid and Its Salts: 

Relevance to Substances Regulated 

Under the Montreal and Kyoto Protocols. 

Report No. 2016–01. February 2016. 

https://ozone.unep.org/sites/default/ 

files/2019-08/TFA2016.pdf. 

XIII. Statutory and Executive Order 

Reviews 

Additional information about these 

statutes and Executive orders can be 

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

regulations/and-executive-orders. 

A. Executive Order 12866: Regulatory 

Planning and Review and 14094: 

Modernizing Regulatory Review 

This action is not a significant 

regulatory action under Executive Order 

12866 (58 FR 51735, October 4, 1993), 

as amended by Executive Order 14094 


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(88 FR 21879, April 11, 2023), and was 

therefore not subject to Executive Order 

12866 review. 

B. Paperwork Reduction Act (PRA) 

This action does not impose any new 

information collection burden under the 

PRA, 44 U.S.C. 3501 et seq. The Office 

of Management and Budget (OMB) has 

previously approved the information 

collection activities contained in the 

existing regulations and has assigned 

OMB control numbers 2070–0038 (EPA 

ICR No. 1188.13) and 2070–0030 (EPA 

ICR No. 0795.16). If an entity were to 

submit a SNUN to the Agency, the 

annual burden is estimated to be less 

than 100 hours per response, and the 

estimated burden for export 

notifications is less than 1.5 hours per 

notification. In both cases, burden is 

estimated to be reduced for submitters 

who have already registered to use the 

electronic submission system. 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 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 

small entities subject to the 

requirements of this action are potential 

future manufacturers (defined by statute 

to include importers), processors, and 

exporters of one or more subject 

chemical substances for a significant 

new use designated in the SNUR. 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, 

the Agency has determined that no 

small or large entities presently engage 

in such activities. A SNUR requires that 

any person who intends to engage in 

such activity in the future must first 

notify EPA by submitting a SNUN. 

EPA’s experience to date is that, in 

response to the promulgation of SNURs 

covering over 1,000 chemicals, the 

Agency receives only a small number of 

notices per year. For example, the 

number of SNUNs received was 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 $11,204 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 final SNURs are not 

expected to have a significant economic 

impact on a substantial number of small 

entities, which was provided to the 

Chief Counsel for Advocacy of the Small 

Business Administration. 

D. Unfunded Mandates Reform Act 

(UMRA) 

This action does not contain any 

unfunded mandates as described in 

UMRA, 2 U.S.C. 1531–1538, and does 

not significantly or uniquely affect small 

governments. Based on EPA’s 

experience with proposing and 

finalizing SNURs, state, local, and tribal 

governments have not been impacted by 

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 final rule will 

not impose any enforceable duty, 

contain any unfunded mandate, or the 

otherwise have any effect on small 

governments subject to the requirements 

of UMRA section 202, 203, 204, or 205 

(2 U.S.C. 1501 et seq.). 

E. Executive Order 13132: Federalism 

This action does not have federalism 

implications as specified in Executive 

Order 13132 (64 FR 43255, August 10, 

1999) because it will not have 

substantial direct effects on the 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. 

F. Executive Order 13175: Consultation 

and Coordination With Indian Tribal 

Governments 

This action does not have tribal 

implications as specified in Executive 

Order 13175 (65 FR 67249, November 9, 

2000) because it will not have 

substantial direct effects on tribal 

governments, on the relationship 

between the Federal Government and 

the Indian tribes, or on the distribution 

of power and responsibilities between 

the Federal Government and Indian 

tribes. Thus, Executive Order 13175 

does not apply to this action. 

G. Executive Order 13045: Protection of 

Children From Environmental Health 

Risks and Safety Risks 

EPA interprets Executive Order 13045 

as applying only to those regulatory 

actions that concern environmental 

health or safety risks that EPA has 

reason to believe may 

disproportionately affect children, per 

the definition of ‘‘covered regulatory 

action’’ in section 2–202 of the 

Executive order. Therefore, this action is 

not subject to Executive Order 13045 

because it does not concern an 

environmental health risk or safety risk. 

Since this action does not concern 

human health, EPA’s Policy on 

Children’s Health also does not apply. 

Although this action does not concern 

an environmental health or safety risk, 

the designation of certain uses of PFAS 

as significant new uses ensures the 

Agency has an opportunity to review 

and address potential risks associated 

with such uses before an entity begins 

commencing any manufacture 

(including import) or processing of 

PFAS for that use. Once EPA receives a 

notification, EPA must review and make 


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Federal Register / Vol. 89, No. 8 / Thursday, January 11, 2024 / Rules and Regulations 1831 

an affirmative determination on the 

notification, and take such action as is 

required by any such determination 

before the manufacture (including 

import) or processing for the significant 

new use can commence. Such a review 

will assess whether the use identified in 

the SNUN may present unreasonable 

risk to health or the environment and 

ensure that EPA can prevent future 

unsafe environmental releases of PFAS 

subject to the SNUR. As discussed 

previously, EPA is concerned about the 

potential for adverse health effects from 

PFAS for children and will evaluate the 

risk. 

H. Executive Order 13211: Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use 

This action is not subject to Executive 

Order 13211 (66 FR 28355, May 22, 

2001), because it is not a ‘‘significant 

regulatory action’’ under Executive 

Order 12866. 

I. National Technology Transfer and 

Advancement Act (NTTAA) 

This action does not involve any 

technical standards under the NTTAA 

section 12(d), 15 U.S.C. 272. 

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 

The EPA believes that it is not 

practicable to assess whether the human 

health or environmental conditions that 

exist prior to this action result in 

disproportionate and adverse effects on 

communities with environmental justice 

concerns. 

The Agency believes that the inactive 

PFAS included in this action are no 

longer being manufactured (including 

imported) or processed for any uses in 

the United States. EPA believes that it 

is not practicable to assess whether this 

action is likely to result in new 

disproportionate and adverse effects on 

environmental justice communities 

because the Agency is not able 

anticipate which chemical substances 

and uses, if any, will be submitted for 

a significant new use notice under this 

action. 

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: January 8, 2024. 

Michal Freedhoff, 

Assistant Administrator, Office of Chemical 

Safety and Pollution Prevention. 

Therefore, for the reasons set forth 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 § 9.1 in the table by adding 

an entry for § 721.11777 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 

* * * * * 

721.11777 ............................. 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). 

■ 4. Add § 721.11777 in numerical order 

to subpart E to read as follows: 

§ 721.11777 Per- and poly-fluoroalkyl 

chemical substances designated as inactive 

on the TSCA Inventory. 

(a) Definitions. The definitions in 

§ 721.3 apply to this section. 

(b) Chemical substances and 

significant new uses subject to reporting. 

(1) The 329 chemical substances 

identified in paragraphs (b)(1)(i) through 

(iii) of this section, designated as 

inactive on the TSCA Chemical 

Substance Inventory as of January 26, 

2023, are subject to reporting under this 

section for the significant new uses 

described in paragraph (b)(2) of this 

section. The requirements of this section 

do not apply to quantities of the 

substance that are manufactured or 

processed as nonisolated intermediates, 

as defined at 40 CFR 720.3(w), or to 

quantities of the substance that are 

manufactured or processed as a 

byproduct, as defined in 40 CFR 

720.3(d), which are not used for 

commercial purposes. 

(i) R-(CF2)-CF(R′)′′, where both the 

CF2 and CF moieties are saturated 

carbons; 

(ii) R-CF2OCF2-R′, where R and R′ 

can either be F, O, or saturated carbons; 

and 

(iii) CF3C(CF3)R′R′′, where R′ and R′′ 

can either be F or saturated carbons. 

(2) The significant new uses for the 

chemical substances identified in 

paragraph (b)(1) of this section are: 

manufacture (including import) or 

processing for any use. 

(c) Chemical substances not subject to 

reporting. The chemical substances 

already subject to a rule under this part, 

including § 721.9582, and § 721.10536, 

are not subject to reporting under this 

section. 

(d) Specific requirements. The 

provisions of subpart A of this part 

apply to this section. 

[FR Doc. 2024–00412 Filed 1–10–24; 8:45 am] 

BILLING CODE 6560–50–P 


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