Per- and Poly-Fluoroalkyl Chemical Substances Designated as Inactive on the TSCA Inventory; Significant New Use Rule, 4937-4945 [2023-01156]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 88, Number 17 (Thursday, January 26, 2023)]
[Proposed Rules]
[Pages 4937-4945]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-01156]



[[Page 4937]]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2022-0867; FRL 9655-01-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: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: Under the Toxic Substances Control Act (TSCA), EPA is 
proposing a significant new use rule (SNUR) for those per- and poly-
fluoroalkyl substances (PFAS) that have not been manufactured 
(including imported) or processed for many years and are consequently 
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 SNUR would be 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 use may present 
unreasonable risk to health or the environment and ensure that EPA can 
prevent future unsafe environmental releases of the PFAS subject to 
this SNUR.

DATES: Comments must be received on or before March 27, 2023.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2022-0867, using the Federal eRulemaking Portal 
at https://www.regulations.gov. Follow the online instructions for 
submitting comments. Do not submit electronically any information you 
consider to be Confidential Business Information (CBI) or other 
information whose disclosure is restricted by statute. Additional 
instructions on commenting or visiting the docket, along with more 
information about dockets generally, is available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: 
    For technical information 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: [email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: [email protected].

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 324--Petroleum and Coal Product Manufacturing;
     NAICS 221210--Natural Gas Distribution;
     NAICS 236220--Commercial and Institutional Building 
Construction;
     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 certification and export notification rules under TSCA. Persons 
who import any chemical substance governed by a final SNUR are subject 
to the TSCA section 13 (15 U.S.C. 2612) import certification 
requirements and the corresponding regulations 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

[[Page 4938]]

at 40 CFR part 707, subpart B. In addition, any persons who export or 
intend to export a chemical substance that is the subject of a proposed 
or final SNUR are subject to the export notification provisions of TSCA 
section 12(b) (15 U.S.C. 2611(b)); (see also 40 CFR part 707, subpart D 
and 40 CFR 721.20).
    If you have any questions regarding the applicability of this 
action to a particular entity, consult the technical information 
contact listed under FOR FURTHER INFORMATION CONTACT.

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) (see 
Unit IV). 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?

    To protect health and the environment and ensure EPA review of 
significant new uses of certain PFAS, EPA is proposing a SNUR for those 
PFAS that are currently on the TSCA Inventory but which have not been 
actively manufactured (including imported) or processed in the U.S. 
since 2006 and are consequently designated as inactive on the TSCA 
Chemical Substance Inventory. PFAS are a group of synthetic chemicals 
that have been in use since the 1940s and are still used in a wide 
range of consumer products and industrial applications. This proposed 
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. 1).
    If a chemical is on the TSCA Chemical Substance Inventory (``TSCA 
Inventory''), that chemical substance is considered an ``existing'' 
chemical substance in U.S. commerce. In some instances, the chemicals 
listed on the TSCA Inventory have not been actively manufactured for 
many years and are designated as ``inactive'' on the TSCA Inventory. 
The chemical substances for which EPA is proposing a SNUR are those 
PFAS that are both currently designated as inactive on the TSCA 
Inventory and not subject to an existing SNUR, including the existing 
SNURs cited at 40 CFR 721.9582 and 721.10536. This category of PFAS 
chemical substances (``inactive PFAS'') is described further in Unit 
II.A. There are 330 inactive PFAS that are not subject to an existing 
SNUR. The specific chemical identities for 30 of these substances that 
have been claimed as CBI have generic names (the nonconfidential 
substitute for the specific chemical name) that do not contain 
``fluor'' or ``fluorine.''
    The proposed significant new uses are manufacture (including 
import) or processing for any use. The proposed significant new uses 
EPA has identified in this unit are based on reasonably available 
information that indicates that these uses are not ongoing at the time 
of this proposed rule; according to the TSCA Inventory they are 
inactive, meaning that those chemicals have not been manufactured 
(including imported) or processed in the United States since June 21, 
2006. EPA is requesting public comment on this proposal, and 
specifically on the Agency's description of the significant new uses 
for the chemicals identified, including specific documentation of 
ongoing uses, if any.
    This proposed SNUR would require persons that intend to manufacture 
(including import) or process any of these chemicals for a significant 
new use, consistent with the requirements at 40 CFR 721.25, to notify 
EPA at least 90 days before commencing such manufacture (including 
import) or processing. Once EPA receives a notification, EPA must 
either determine that the significant new use is not likely to present 
an unreasonable risk of injury to health or the environment, or take 
such regulatory action as is associated with an alternative 
determination, before the manufacture or processing for the significant 
new use could commence.

D. Why is the Agency taking this action?

    As noted previously, 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. 1). When TSCA was first passed, 
thousands of chemicals, including some PFAS, were grandfathered in 
under the statute and allowed to remain in commerce without additional 
EPA review. Before TSCA was amended in 2016, EPA completed formal 
reviews on only about 20% of new chemicals and had no authority to 
address new chemicals about which the Agency lacked sufficient 
information, which is part of the reason why many chemicals, including 
PFAS, were allowed into commerce without a complete review. Under the 
new law, the agency has to formally review the safety of 100% of new 
chemicals before they are allowed into commerce. 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. 
This proposed 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, and to ensure that an appropriate 
determination (relevant to the risks associated with such manufacturing 
(including import), processing, distribution in commerce, use and 
disposal) has been issued prior to the commencement of such 
manufacturing (including import) or processing. The proposed action is 
necessary to ensure that manufacturing (including importing) or 
processing for the significant new use cannot proceed in the event that 
EPA determines that: (1) The significant new use presents an 
unreasonable risk under the conditions of use (without consideration of 
costs or other nonrisk factors, and including an unreasonable risk to a 
potentially exposed or susceptible subpopulation identified as relevant 
by EPA); (2) The information available to EPA is insufficient to permit 
a reasoned evaluation of the health and environmental effects of the 
significant new use; (3) In the absence of sufficient information, the 
manufacture (including import), processing, distribution in commerce, 
use, or disposal of the substance, or any combination of such

[[Page 4939]]

activities, may present an unreasonable risk (without consideration of 
costs or other nonrisk factors, and including an unreasonable risk to a 
potentially exposed or susceptible subpopulation identified as relevant 
by EPA), or (4) There is sufficient potential for environmental release 
or human exposure (as defined in TSCA section 5(a)(3)(B)(ii)(II)). In 
order for manufacturing (including importing) or processing for the 
significant new use to proceed after EPA has made one of the 4 
determinations described above, EPA must take actions under TSCA 
sections 5(e) or 5(f) to protect health and the environment.
    With respect to the chemical substances listed in the proposed 
regulatory text, all manufacturing (including importing) and processing 
ceased on or before June 21, 2006, as discussed in Unit II.A. Any new 
manufacturing (including importing) or processing for any use following 
that date would thus significantly change the volume of production, 
which is believed to be negligible.
    EPA is proposing to exempt from the notice requirement PFAS present 
as impurities, certain byproducts, and the importing or processing of 
inactive PFAS-containing articles defined at 40 CFR 721.45(d) through 
(f) 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)).
    The rationale and objectives for this proposed 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 
proposed rule. This analysis (Ref. 2), 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 $26,737 per SNUN submission for large business submitters 
and $11,047 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 $106 per 
notification.

F. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
https://www.regulations.gov or email. Clearly mark the part or all the 
information that you claim to be CBI. For CBI information in a disk or 
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as 
CBI, and then identify electronically within the disk or CD-ROM the 
specific information that is claimed as CBI. In addition to one 
complete version of the comment that includes information claimed as 
CBI, a copy of the comment that does not contain the information 
claimed as CBI must be submitted for inclusion in the public docket. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting 
your comments, see the commenting tips at https://www.epa.gov//commenting-epa-dockets.
    3. Comments about ongoing uses of inactive PFAS. EPA welcomes 
comment on all aspects of this proposed rule. In providing comments on 
an ongoing use of inactive PFAS, it would be helpful if you provide 
sufficient information for EPA to substantiate any assertions of an 
ongoing use.

II. Chemical Substances Subject to This Proposed Rule

A. What chemicals substances are subject to this proposed SNUR?

    This proposed SNUR would apply to chemical substances designated as 
inactive on the TSCA Inventory that are also PFAS. However, EPA is 
proposing 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 section to avoid potential redundancies or 
conflicts between the SNURs. Inactive chemical substances on the TSCA 
Inventory are those chemical substances that have not been manufactured 
(including imported) or processed since June 21, 2006.
    TSCA section 8(b) requires EPA to compile, keep current and publish 
a list of each chemical substance that is manufactured (including 
imported) or processed in the United States for uses under TSCA. Also 
called the ``TSCA Inventory'' or simply ``the Inventory,'' it plays a 
central role in the regulation of most industrial chemicals in the 
United States. TSCA also requires EPA to designate each chemical 
substance on the TSCA Inventory as either ``active'' or ``inactive'' in 
U.S. commerce (15 U.S.C. 2607(b)(4)(A)). To accomplish that, EPA 
finalized a rule requiring industry to notify the Agency of each 
chemical substance manufactured (including imported) or processed in 
the U.S. over a 10-year period ending on June 21, 2016 (with certain 
exemptions from reporting at 40 CFR 710.27(a)) (Ref. 3). This reporting 
was completed on October 5, 2018 and, combined with data received under 
the Chemical Data Reporting (CDR) rule in 2012 and 2016, was used to 
designate each chemical substance on the TSCA Inventory as active or 
inactive in U.S. commerce. Starting August 5, 2019, manufacturers 
(including importers) and processors have been required to notify EPA 
before reintroducing inactive substances into U.S. commerce. Moving a 
chemical substance from an inactive designation to an active 
designation on the TSCA Inventory does not require review by EPA, only 
that EPA be notified via a Notice of Activity form.
    EPA has published several SNURs covering certain perfluoroalkyl 
sulfonates (67 FR 11007, March 11, 2002 (FRL-6823-6); 67 FR 72854, 
December 9, 2002 (FRL-7279-1); 72 FR 57222, October. 9, 2007 (FRL-8150-
4); 78 FR 62443, October 22, 2013 (FRL-9397-1)) and long-chain 
perfluoroalkyl carboxylate chemical substances (85 FR 45124, July 27, 
2020 (FRL-10010-44)), that use a structural definition, as opposed to a 
discrete list, for the PFAS covered in the SNURs. Additionally, other 
SNURs (85 FR 45124, July 27, 2020 (FRL-10010-44; 58 FR 27944, May 12, 
1993 (FRL-4077-7), as amended at 58 FR 34204, June 23, 1993 (FRL-4587-
1)) and the polymer exemption rule for pre-manufacture notices (PMNs) 
(60 FR 16316-16336, March 29, 1995 (FRL-4929-8)) define covered PFAS 
polymers using structural definitions (40 CFR 723.250)). Other 
scientific and regulatory bodies such as the Organization of Economic 
Cooperation and Development (OECD) (Ref. 4) have defined PFAS using 
various structural definitions. Thus, there is precedent for using a 
structural definition both for TSCA rules and for actions addressing 
PFAS. EPA is proposing to adopt a structural definition for this rule 
based, in part, on this history of using structural definitions to 
establish the scope of chemical substances covered by a SNUR.
    For the purposes of this proposed SNUR, the definition of ``PFAS'' 
includes chemicals that contain at least one of these three structures:

[[Page 4940]]

     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.
    While this proposed definition was developed to focus on substances 
most likely to be persistent in the environment while excluding those 
substances that are ``lightly'' fluorinated (i.e., the molecule only 
contains unconnected CF2 or CF3 moieties), EPA acknowledges that 
substances that are not fully fluorinated may still be persistent in 
the environment, as the persistence of organofluoro compounds is more 
related to the density of C-F bonds within the molecule than to the 
existence of fully fluorinated carbons. For this SNUR, the proposed 
definition's R group requirements do not include substances that only 
have a single fluorinated carbon, or unsaturated fluorinated moieties 
(e.g., fluorinated aromatic rings and olefins), which are more 
susceptible to chemical transformation than their saturated 
counterparts, and therefore, are less likely to persist in the 
environment (Ref. 5). As such, EPA has determined that, for the purpose 
of this proposed rule, the definition does not include substances that 
only have a single fluorinated carbon or unsaturated fluorinated 
moieties.
    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 term ``PFAS'' has been used broadly 
for varying research and/or regulatory needs. Various EPA programs may 
have distinct needs or purposes from this proposed SNUR, and therefore, 
different definitions of the term ``PFAS'' may be appropriate for other 
purposes. EPA does not have one Agency-wide definition of PFAS. For 
example, a definition from EPA's Office of Water might focus on PFAS 
that have been detected in water, whereas a definition for TSCA might 
be one for PFAS that are expected the be manufactured and processed for 
uses subject to TSCA. The Agency notes that this perspective, that 
different entities may have very different needs and no single PFAS 
characterization or definition meets all needs, is shared by other 
organizations, including the OECD (Ref. 4). EPA seeks comment on 
whether the above definition of PFAS is the most appropriate definition 
for this SNUR and acknowledges that there may be other rules or 
programs that apply different definitions to meet their own needs.
    Chemical substances that fall within the scope of this proposed 
definition of PFAS encompass chemical substances that meet the 
structural definitions used in existing SNURs covering PFAS. However, 
the proposed regulatory text clarifies that PFAS subject to an existing 
SNUR would be excluded from this proposed SNUR. The Agency is proposing 
to exclude these substances from the scope of this proposed rule to 
avoid potential redundancies or conflicts between the SNURs. Such 
conflicts may arise because of chemical or use-specific exemptions from 
the existing significant new uses or because EPA had a reason to lift 
general exemptions from an existing SNUR that would still apply under 
this proposed SNUR.
    The chemical substances for which EPA is proposing a SNUR are the 
330 PFAS that are both currently designated as inactive on the TSCA 
Inventory and not subject to an existing SNUR. The specific chemical 
identities for 30 of these substances that have been claimed as 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 300 inactive PFAS that do not mask ``fluor'' or 
``fluorine'' in the generic name in the public docket for this proposed 
rule (Ref. 6). Because EPA is proposing to use a structural definition 
of PFAS for this SNUR, EPA need not take additional steps to ensure 
that the SNUR lists the 30 inactive PFAS that are not subject to an 
existing SNUR and whose generic names do not contain ``fluor'' or 
``fluorine''. The specific chemical identities of these substances have 
been claimed as CBI, and their generic names are the nonconfidential 
substitute for the specific chemical name that is treated as 
confidential. TSCA section 14(c)(1)(C) requires that generic names 
describe the chemical structure of the chemical substance as 
specifically as practicable while protecting those features of the 
chemical structure that are claimed as confidential; and the disclosure 
of which would be likely to cause substantial competitive harm. Generic 
names are intended to reveal information about the chemical identity 
while masking those structural elements that are confidential. The lack 
of ``fluor'' or ``fluorine'' in a generic name masks that the chemical 
substance is a PFAS and information masked by a generic name is 
considered to be subject to a CBI claim. Therefore, listing the generic 
names of these substances on a list of PFAS would disclose structural 
information for these substances that has been claimed CBI. As a 
courtesy, EPA is also providing a list of 300 inactive PFAS that do not 
mask ``fluor'' or ``fluorine'' in the generic name in the public docket 
for this proposed rule (Ref. 6).
    EPA seeks comment on whether the Agency should take further 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, including those with generic names that mask that the 
chemical substance as PFAS, since this proposed rule covers a specific 
list of substances. EPA describes two approaches that it could take to 
make such a list available below and seeks public input on each such 
approach.
    First, EPA could determine that there are no applicable CBI claims 
for the generic names of the masked PFAS substances using the process 
described in 40 CFR 2.204(c). In other words, EPA could use that 
process to determine that the limited structural information that would 
be disclosed by identifying substances whose generic names do not 
include ``fluor'' or ``fluorine'' as PFAS is not CBI. EPA proposes 
making a good faith effort to identify and contact the original 
submitters of each such PFAS and/or document that EPA cannot find a 
successor entity to a submitter that does not continue to operate, then 
determining that the generic names that do not include ``fluor'' or 
``fluorine'' are not entitled to confidential treatment under 40 CFR 
2.204(c)(3).
    Alternatively, EPA could use the process under TSCA section 
14(d)(7) and 40 CFR 2.306(i)/2.301(g)(2), whereby the Agency may 
disclose information claimed CBI if the Administrator determines that 
disclosure is relevant in a proceeding under TSCA and the disclosure 
preserves confidentiality to the extent practicable without impairing 
the proceeding. Under this alternative, EPA would not disclose the 
specific chemical identity as part of the rulemaking. Rather, EPA would 
list the generic names that lack fluor or fluorine, disclosing that the 
chemical is a PFAS. EPA believes this is a limited form of disclosure 
that would be consistent with TSCA section 14(d)(7).

B. What are the uses and production volumes of inactive PFAS?

    As discussed previously, the term inactive PFAS refers to PFAS that 
EPA designated as ``inactive'' in U.S. commerce on the TSCA Inventory 
(15 U.S.C. 2607(b)(4)(A)). Starting August 5, 2019, manufacturers 
(including importers) and processors have been required to provide 
notice to EPA to

[[Page 4941]]

change the commercial activity designation from inactive to active 
before using a chemical substance designated as inactive on the TSCA 
Inventory for a nonexempt commercial purpose (Ref. 3). The Agency has 
not received such notifications for any of the PFAS currently 
designated as inactive on the TSCA Inventory. This indicates that all 
such PFAS, which include the PFAS covered by this proposed SNUR, are no 
longer being manufactured (including imported) or processed for any 
nonexempt uses in the United States. 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, the 
import or processing of a chemical substance as part of an article (40 
CFR 710.27(a)(2)) and the manufacturing or processing of a chemical 
substance in small quantities solely for research and development (40 
CFR 710.27(a)(1)). Thus, there may be ongoing uses of inactive PFAS for 
these exempt activities. These uses would be exempt from this proposed 
inactive SNUR pursuant to the general SNUR exemptions at 40 CFR 721.45. 
The Agency solicits comment on any ongoing activities exempt from the 
Active-Inactive Rule that entities believe would not be covered by the 
general SNUR exemptions. The Agency expects to receive additional 
information about any ongoing use of PFAS in processed or imported 
articles as part of the separate TSCA section 8(a)(7) PFAS reporting 
rule that was proposed on June 28, 2021 (June 28, 2021, 86 FR 33962), 
once it is finalized, and EPA may consider making inapplicable the 
exemption for articles in the future, as discussed in Unit X.
    The Active-Inactive Rule also includes an exemption from 
notification for the manufacturing or processing of a chemical 
substance as described in 40 CFR 720.30(g) or (h) (40 CFR 
710.27(a)(3)). Relevant to this proposed rule, the exemption at 40 CFR 
720.30(h) covers ``[a]ny byproduct which is not used for commercial 
purposes.'' Thus, there may be inactive PFAS that were not reported 
under the Active-Inactive Rule because they were only manufactured or 
processed as byproducts that are not used for commercial purposes. 
There is no such broad exemption for byproducts in EPA's general SNUR 
regulations at 40 CFR 721.45. Rather, EPA has only exempted byproducts 
from SNUR notification requirements in the limited circumstances where:

[t]he person manufactures, imports, or processes the substance only 
as a byproduct which is used only by public or private organizations 
that (1) burn it as a fuel, (2) dispose of it as a waste, including 
in a landfill or for enriching soil, or (3) extract component 
chemical substances from it for commercial purposes. 40 CFR 
721.45(e).

Therefore, without an exemption in the general regulations or in the 
proposed regulatory text, manufacturing or processing of the inactive 
PFAS as a byproduct would be a significant new use. EPA solicits 
comment on any ongoing manufacturing or processing of inactive PFAS 
subject to this SNUR as a byproduct and whether to include a broader 
exemption for manufacturing or processing as a byproduct in this 
inactive PFAS SNUR.

C. What are the potential routes and sources of exposure to inactive 
PFAS?

    Due to their widespread use and persistence in the environment, 
most people in the United States have been exposed to PFAS. Biological 
sampling has discovered the presence of certain PFAS in fish and in 
fish-eating birds across the United States and in locations in Canada, 
Sweden, and the South Pacific. The wide distribution of the chemicals 
in high trophic levels is strongly suggestive of the potential for 
bioaccumulation and/or bioconcentration. Based on currently available 
information, EPA believes that in addition to persistence, the length 
of the perfluorinated chain may also have an effect on bioaccumulation 
and toxicity, which are characteristics of concern for these chemicals 
(Ref. 7). EPA expects that there are likely limited potential routes 
and sources of exposure to the inactive PFAS covered by the proposed 
SNUR because these substances have not been manufactured or processed 
for nonexempt uses in the United States since 2006. However, exposure 
may be possible because some PFAS are known to persist in the 
environment and have been shown to bioaccumulate in wildlife and humans 
(Refs. 7 and 8).

III. Rationale and Objectives

A. What is the rationale?

    When TSCA was first passed, thousands of chemicals, including some 
PFAS, were grandfathered in under the statute and allowed to remain in 
commerce without additional EPA review. Before TSCA was amended in 
2016, EPA completed formal reviews on only about 20% of new chemicals 
and had no authority to address new chemicals about which the Agency 
lacked sufficient information, which is part of the reason why many 
chemicals, including PFAS, were allowed into commerce without a 
complete review. Under the new law, the agency has to formally review 
the safety of 100% of new chemicals before they are allowed into 
commerce. On October 18, 2021, EPA issued the ``PFAS Strategic Roadmap: 
EPA's Commitments to Action 2021-2024'' (Ref. 1). This proposed 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 Roadmap, EPA committed to 
considering how to apply TSCA section 5(a)(2) authority to help address 
abandoned uses of PFAS as well as future uses of PFAS designated as 
inactive on the TSCA Inventory.
    In the absence of a SNUR, manufacturing (including importing) or 
processing for the significant new uses proposed in this rule may 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. EPA believes that 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 that are persistent and bioaccumulate. Given the concerns 
described in Unit II., EPA believes 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), EPA's decision to propose 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. If a 
person decides to begin manufacturing (including importing) or 
processing any of these chemicals for the use, the notice to EPA allows 
the Agency to evaluate the 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?

    Based on the considerations in Unit III.A., EPA wants to achieve 
the following objectives with regard to the significant new use(s) of 
inactive PFAS that are designated in this proposed rule:

[[Page 4942]]

    1. EPA would 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.
    2. EPA would 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.
    3. 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 would constitute 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 section 5(a)(2) of TSCA. Since the manufacture 
(including import) and processing of inactive PFAS has been 
discontinued in the United States see Unit II., 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. Based on consideration of the 
statutory factors discussed herein, EPA has preliminarily determined as 
significant new uses: manufacture (including import) or processing of 
inactive PFAS for any use.

V. Applicability of General Provisions

    General provisions for SNURs appear under 40 CFR part 721, subpart 
A. These provisions describe persons subject to the proposed rule, 
recordkeeping requirements, exemptions to reporting requirements, and 
applicability of the proposed 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 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 the 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 the 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 is being proposed on 
January 26, 2023. Uses arising after the publication of the proposed 
rule are distinguished from uses that exist 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.
    Persons who begin commercial manufacturing (including importing) or 
processing of the chemical substances for a significant new use 
identified as of January 26, 2023 would have to cease any such activity 
upon the effective date of the final rule. To resume their activities, 
these persons would have to first comply with all applicable SNUR 
notification requirements and wait until all TSCA prerequisites for the 
commencement of 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 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 40 CFR 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

[[Page 4943]]

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. EPA encourages persons to consult with the Agency before 
submitting a SNUN. As part of this optional pre-notice consultation, 
EPA would discuss specific information it believes may be useful in 
evaluating a significant new use.
    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 
40 CFR 720.40. E-PMN software is available electronically at https://www.epa.gov/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 
proposed rule (Ref. 2). In the event that a SNUN is submitted, costs 
are estimated at approximately $26,737 per SNUN submission for large 
business submitters and $11,047 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 $3,300 (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 proposed rule (Ref. 2).

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 chemical covered in this 
proposed SNUR, as stated in the accompanying economic analysis of this 
proposed SNUR, the estimated cost of the export notification 
requirement on a per unit basis is approximately $106.

X. Regulatory Alternative Considered

    EPA is also requesting public comment on the alternative of lifting 
the article exemption at 40 CFR 721.45(f). Under this alternative, the 
import and processing of articles containing inactive PFAS would be 
designated as a significant new use. EPA is not proposing this 
regulatory alternative, at this time, because it cannot currently 
determine whether or what types of articles containing PFAS covered by 
the definition in this proposed SNUR are ongoing or not. The import or 
processing of substances solely as part of articles is exempt from the 
notification requirements under the Active-Inactive Rule (Ref. 3). 
Consequently, the TSCA Inventory does not list chemical substances that 
are solely processed or imported as part of articles. The TSCA 
Inventory list of inactive PFAS therefore does not take into account 
ongoing importation or processing of PFAS in articles. EPA's SNURs are 
often amended, however, as ongoing uses of the chemical substances are 
phased out. Therefore, as EPA collects evidence and determines that the 
importing or processing of inactive PFAS into articles is no longer 
ongoing, EPA may consider whether to make inapplicable the articles 
exemption at 40 CFR 721.45(f).
    EPA also seeks comment on the potential impact on firms that plan 
to import or process articles containing inactive PFAS, because, while 
not required by the proposed SNUR, these parties may take additional 
steps to determine whether inactive PFAS are part of the articles that 
they are considering to import or process.

XI. 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 proposed significant new use rule, in Unit II. and in the 
references cited throughout the preamble of this proposed rule. EPA 
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

[[Page 4944]]

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.

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. ``PFAS Strategic Roadmap: EPA's Commitment to Action 
2021-2024.'' EPA-100-K-21-002, October 2021.
2. U.S. EPA. ``Economic Analysis of the Proposed Significant New Use 
Rule Per- and Poly-fluoroalkyl Chemical Substances Designated as 
Inactive on the TSCA Inventory.'' January 2022.
3. U.S. EPA. TSCA Inventory Notification (Active-Inactive) 
Requirements; Final Rule, 82 FR 37520, August 11, 2017.
4. 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.
5. Buck, R.C., Korzeniowski, S.H., Laganis, E, and Adamsky, F. 
(2021). ``Identification and classification of commercially relevant 
per[hyphen]and poly[hyphen]fluoroalkyl substances (PFAS).'' 
Integrated Environmental Assessment and Management, 17, 1045-1055.
6. 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.
7. Agency for Toxic Substances and Disease Registry (ATSDR). 
``Toxicological Profile for Perfluoroalkyls.'' May 2021. Available 
from: https://www.atsdr.cdc.gov/toxprofiles/tp200.pdf.
8. 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. (2022). 
Per- and polyfluoroalkyl substances in the environment. Science. 
375: 6580, 1-14.

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 Executive 
Order 13563: Improving Regulation and Regulatory Review

    This action is not a significant regulatory action under Executive 
Order 12866 (58 FR 51735, October 4, 1993) and was therefore not 
submitted to the Office of Management and Budget (OMB) for review under 
Executive Orders 12866 and 13563 (76 FR 3821, January 21, 2011).

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. OMB has previously approved the 
information collection activities contained in the existing regulations 
and has assigned OMB control numbers 2070-0038 (EPA ICR No. 2702.01) 
and the information collection activities associated with export 
notifications are already approved under OMB control number 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.

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. In making this determination, EPA concludes that the impact of 
concern is any significant adverse economic impact on small entities, 
and the Agency is certifying that this proposed rule will not have a 
significant economic impact on a substantial number of small entities.
    A SNUR applies to any person (including small or large entities) 
who intends to engage in any activity described in the proposed rule as 
a ``significant new use.'' By definition of the word ``new'' and based 
on all information currently available to EPA, it appears that no small 
or large entities presently engage in such activities. Since this SNUR 
will require a person who intends to engage in such activity in the 
future to first notify EPA by submitting a SNUN, no economic impact 
will occur unless someone files a SNUN to pursue a significant new use 
in the future or forgoes profits by avoiding or delaying the 
significant new use. Although some small entities may decide to conduct 
such activities in the future, EPA cannot presently determine how many, 
if any, there may be. However, EPA's experience to date is that, in 
response to the promulgation of SNURs covering over 1,000 chemical 
substances, the Agency receives only a handful of notices per year 
(Ref. 2). EPA believes the cost of submitting a SNUN is relatively 
small compared to the cost of developing and marketing a chemical new 
to a firm or marketing a new use of the chemical and that the 
requirement to submit a SNUN generally does not have a significant 
economic impact.
    Therefore, EPA believes that the potential economic impact of 
complying with this proposed SNUR is not expected to be significant or 
adversely impact a substantial number of small entities. In a SNUR that 
published as a final rule on August 8, 1997 (62 FR 42690), the Agency 
presented its general determination that proposed and final SNURs are 
not expected to have a significant economic impact on a substantial 
number of small entities.

D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain any unfunded mandate as described in 
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect 
small governments. The action imposes no enforceable duty on any state, 
local or tribal governments or the private sector.

E. Executive Order 13132: Federalism

    This action does not have federalism implications as specified in 
Executive Order 13132 (64 FR 43255, August 10, 1999). 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). 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,

[[Page 4945]]

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 (62 FR 19885, April 23, 1997), 
as applying only to those regulatory actions that concern environmental 
health or safety risks that the Agency has reason to believe may 
disproportionately affect children, per the definition of ``covered 
regulatory action'' in section 2-202 of the Executive order. This 
action is not subject to Executive Order 13045 because it does not 
concern an environmental health risk or safety risk.

H. Executive Order 13211: Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use

    This action is not a ``significant energy action'' as defined in 
Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not 
likely to have a significant adverse effect on the supply, distribution 
or use of energy and has not otherwise been designated by the 
Administrator of the Office of Information and Regulatory Affairs as a 
significant energy action.

I. National Technology Transfer and Advancement Act (NTTAA)

    This rulemaking does not involve any technical standards under 
section 12(d) of NTTAA, 15 U.S.C. 272 note.

J. Executive Order 12898: Federal Actions To Address Environmental 
Justice in Minority Populations and Low-Income Populations

    Executive Order 12898 (59 FR 7629, February 16, 1994) directs 
Federal agencies, to the greatest extent practicable and permitted by 
law, to make environmental justice part of their mission by identifying 
and addressing, as appropriate, disproportionately high and adverse 
human health or environmental effects of their programs, policies, and 
activities on minority populations (people of color and/or Indigenous 
peoples) and low-income populations.
    EPA believes that the human health and environmental conditions 
that exist prior to this action do not result in disproportionate and 
adverse effects on people of color, low-income populations, and/or 
Indigenous peoples because 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 people of color, low-income populations and/or Indigenous peoples 
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.

List of Subjects in 40 CFR Part 721

    Environmental protection, Chemicals, Hazardous substances, 
Reporting and recordkeeping requirements.

    Dated: January 17, 2023.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.

    Therefore, for the reasons set forth in the preamble, it is 
proposed that 40 CFR chapter I be amended as follows:

PART 721--SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES

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

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

0
2. Add Sec.  721.11777 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 chemical substances identified in paragraphs 
(b)(1)(i) through (iii) of this section, designated as inactive on the 
TSCA Chemical Substance Inventory as of the date of publication of this 
proposed rule, are subject to reporting under this section for the 
significant new uses described in paragraph (b)(2) of this section.
    (i) R-(CF2)-CF(R')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. 2023-01156 Filed 1-25-23; 8:45 am]
BILLING CODE 6560-50-P