[Federal Register Volume 89, Number 8 (Thursday, January 11, 2024)]
[Rules and Regulations]
[Pages 1822-1831]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-00412]


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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.

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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: <a href="/cdn-cgi/l/email-protection#2f7b7c6c6e707f696e7c6f4a5f4e01484059"><span class="__cf_email__" data-cfemail="b2e6e1f1f3ede2f4f3e1f2d7c2d39cd5ddc4">[email protected]</span></a>.
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: <a href="/cdn-cgi/l/email-protection#57030414167a1f38233b3e39321732273679303821"><span class="__cf_email__" data-cfemail="a6f2f5e5e78beec9d2cacfc8c3e6c3d6c788c1c9d0">[email protected]</span></a>.

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:
    <bullet> NAICS 221210--Natural Gas Distribution;
    <bullet> NAICS 236220--Commercial and Institutional Building 
Construction;

[[Page 1823]]

    <bullet> NAICS 324--Petroleum and Coal Product Manufacturing;
    <bullet> NAICS 324--Petroleum and Coal Product Manufacturing;
    <bullet> NAICS 32419--Petroleum Lubricating Oil and Grease 
Manufacturing;
    <bullet> NAICS 325--Chemical Manufacturing;
    <bullet> NAICS 325120--Industrial Gas Manufacturing;
    <bullet> NAICS 325180--Other Basic Inorganic Chemical 
Manufacturing;
    <bullet> NAICS 325199--All Other Basic Organic Chemical 
Manufacturing;
    <bullet> NAICS 325211--Plastics Material and Resin Manufacturing;
    <bullet> NAICS 325212--Synthetic Rubber Manufacturing;
    <bullet> NAICS 325220--Artificial and Synthetic Fibers and 
Filaments Manufacturing;
    <bullet> NAICS 325320--Pesticide and Other Agricultural Chemical 
Manufacturing;
    <bullet> NAICS 325411--Medicinal and Botanical Manufacturing;
    <bullet> NAICS 325412--Pharmaceutical Preparation Manufacturing;
    <bullet> NAICS 325612--Polish and Other Sanitation Good 
Manufacturing;
    <bullet> NAICS 325613--Surface Active Agent Manufacturing;
    <bullet> NAICS 325998--All Other Miscellaneous Chemical Product and 
Preparation Manufacturing;
    <bullet> NAICS 326113--Unlaminated Plastics Film and Sheet (except 
Packaging) Manufacturing;
    <bullet> NAICS 327910--Abrasive Product Manufacturing;
    <bullet> NAICS 333999--All Other Miscellaneous General Purpose 
Machinery Manufacturing;
    <bullet> NAICS 334511--Search, Detection, Navigation, Guidance, 
Aeronautical, and Nautical System and Instrument Manufacturing;
    <bullet> NAICS 336111--Automobile Manufacturing;
    <bullet> NAICS 423120--Motor Vehicle Supplies and New Parts 
Merchant Wholesalers;
    <bullet> NAICS 423420--Office Equipment Merchant Wholesalers;
    <bullet> NAICS 423510--Metal Service Centers and Other Metal 
Merchant Wholesalers;
    <bullet> NAICS 423740--Refrigeration Equipment and Supplies 
Merchant Wholesalers;
    <bullet> NAICS 423990--Other Miscellaneous Durable Goods Merchant 
Wholesalers;
    <bullet> NAICS 424690--Other Chemical and Allied Products Merchant 
Wholesalers;
    <bullet> NAICS 424720--Petroleum and Petroleum Products Merchant 
Wholesalers (except Bulk Stations and Terminals);
    <bullet> NAICS 424950--Paint, Varnish, and Supplies Merchant 
Wholesalers;
    <bullet> NAICS 441110--New Car Dealers;
    <bullet> NAICS 447190--Other Gasoline Stations;
    <bullet> NAICS 551112--Offices of Other Holding Companies; and
    <bullet> 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

[[Page 1824]]

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:
    <bullet> R-(CF2)-CF(R')R'', where both the CF2 and CF moieties are 
saturated carbons;
    <bullet> R-CF2OCF2-R', where R and R' can either be F, O, or 
saturated carbons; or
    <bullet> 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 Per- and 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

[[Page 1825]]

objectives with regard to the significant new use(s) of inactive PFAS 
that are designated in this rule:
    <bullet> 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.
    <bullet> 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.
    <bullet> 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:
    <bullet> The projected volume of manufacturing and processing of a 
chemical substance.
    <bullet> The extent to which a use changes the type or form of 
exposure of human beings or the environment to a chemical substance.
    <bullet> The extent to which a use increases the magnitude and 
duration of exposure of human beings or the environment to a chemical 
substance.
    <bullet> 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 non-isolated 
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 Active-Inactive 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:
    <bullet> As impurities,
    <bullet> As byproducts not used for commercial purposes,
    <bullet> In small quantities solely for research and 
development,
    <bullet> For test marketing purposes,
    <bullet> For use as a non-isolated intermediate, or
    <bullet> 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 Pre-manufacture 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

[[Page 1826]]

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/chemicals-under-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

[[Page 1827]]

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 
chemical-specific 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-by-
chemical 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

[[Page 1828]]

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.

[[Page 1829]]

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 post-Lautenberg 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, non-
isolated 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 Poly-fluoroalkyl 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

[[Page 1830]]

(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

[[Page 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

0
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.


0
2. Amend Sec.  9.1 in the table by adding an entry for Sec.  721.11777 
in numerical order under the undesignated center heading ``Significant 
New Uses of Chemical Substances'' to read as follows:


Sec.  9.1  OMB approvals under the Paperwork Reduction Act.

* * * * *

------------------------------------------------------------------------
                                                            OMB control
                     40 CFR citation                            No.
------------------------------------------------------------------------
 
                                * * * * *
------------------------------------------------------------------------
               Significant New Uses of Chemical Substances
------------------------------------------------------------------------
 
                                * * * * *
------------------------------------------------------------------------
721.11777...............................................       2070-0038
 
                                * * * * *
------------------------------------------------------------------------

* * * * *

PART 721--SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES

0
3. The authority citation for part 721 continues to read as follows:

    Authority:  15 U.S.C. 2604, 2607, and 2625(c).


0
4. Add Sec.  721.11777 in numerical order to subpart E to read as 
follows:


Sec.  721.11777  Per- and poly-fluoroalkyl chemical substances 
designated as inactive on the TSCA Inventory.

    (a) Definitions. The definitions in Sec.  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 Sec.  
721.9582, and Sec.  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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