[Federal Register Volume 89, Number 195 (Tuesday, October 8, 2024)]
[Proposed Rules]
[Pages 81776-81814]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-22966]



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Vol. 89

Tuesday,

No. 195

October 8, 2024

Part III





 Environmental Protection Agency





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40 CFR Part 372





Addition of Certain Per- and Polyfluoroalkyl Substances (PFAS) to the 
Toxics Release Inventory (TRI); Proposed Rule

Federal Register / Vol. 89, No. 195 / Tuesday, October 8, 2024 / 
Proposed Rules

[[Page 81776]]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 372

[EPA-HQ-OPPT-2023-0538; FRL-9313-01-OCSPP]
RIN 2070-AL03


Addition of Certain Per- and Polyfluoroalkyl Substances (PFAS) to 
the Toxics Release Inventory (TRI)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to add 
16 individually listed per- and polyfluoroalkyl substances (PFAS) and 
15 PFAS categories to the Toxics Release Inventory (TRI) list of toxic 
chemicals subject to reporting under the Emergency Planning and 
Community Right-to-Know Act (EPCRA) and the Pollution Prevention Act 
(PPA) to comply with the National Defense Authorization Act for Fiscal 
Year 2020 (NDAA). EPA also addresses how PFAS categories should be 
treated. Separately, EPA discusses what events may trigger the 
automatic addition of a PFAS to the TRI pursuant to the NDAA. This 
discussion does not propose to list chemicals to TRI pursuant to the 
NDAA, but rather describes what EPA documents and activities involving 
PFAS would trigger an automatic addition under the NDAA.

DATES: Comments must be received on or before December 9, 2024. 
Comments on the information collection provisions submitted to the 
Office of Management and Budget (OMB) under the Paperwork Reduction Act 
(PRA) are best assured of consideration by OMB if OMB receives a copy 
of your comments on or before November 7, 2024.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2023-0538, through 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: 
Rachel Dean, Data Gathering, Analysis, Management, and Policy Division, 
Mailcode 7406M, Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, 
DC 20460-0001; telephone number: (202) 566-1303; email address: 
<a href="/cdn-cgi/l/email-protection#305455515e1e42515358555c705540511e575f46"><span class="__cf_email__" data-cfemail="ef8b8a8e81c19d8e8c878a83af8a9f8ec1888099">[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, 
process, or otherwise use any of the PFAS listed in this rule. The 
following list of North American Industry 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> Facilities included in the following NAICS manufacturing 
codes (corresponding to Standard Industrial Classification (SIC) codes 
20 through 39): 311*, 312*, 313*, 314*, 315*, 316, 321, 322, 323*, 324, 
325*, 326*, 327*, 331, 332, 333, 334*, 335*, 336, 337*, 339*, 111998*, 
211130*, 212323*, 212390*, 488390*, 5131*, 512230*, 512250*, 516210*, 
519290*, 541713*, 541715* or 811490*. * Exceptions and/or limitations 
exist for these NAICS codes.
    <bullet> Facilities included in the following NAICS codes 
(corresponding to SIC codes other than SIC codes 20 through 39): 
212114, 212115, or 212220, 212230, 212290*; or 2211*, 221210*, 221330 
(limited to facilities that combust coal and/or oil for the purpose of 
generating power for distribution in commerce) (corresponds to SIC 
codes 4911, 4931, and 4939, Electric Utilities); or 424690, 424710 
(corresponds to SIC code 5171, Petroleum Bulk Terminals and Plants); 
425120 (limited to facilities previously classified in SIC code 5169, 
Chemicals and Allied Products, Not Elsewhere Classified); or 562112 
(limited to facilities primarily engaged in solvent recovery services 
on a contract or fee basis (previously classified under SIC code 7389, 
Business Services, NEC)); or 562211*, 562212*, 562213*, 562219*, 
562920* (limited to facilities regulated under the Resource 
Conservation and Recovery Act, subtitle C, 42 U.S.C. 6921 et seq.) 
(corresponds to SIC code 4953, Refuse Systems).
    <bullet> Federal facilities.
    <bullet> Facilities that the EPA Administrator has specifically 
required to report to TRI pursuant to a determination under EPCRA 
section 313(b)(2).
    A more detailed description of the types of facilities covered by 
the NAICS codes subject to reporting under EPCRA section 313 can be 
found at https://www.epa.gov/toxics-release-inventory-tri-program/tri-covered-industry-sectors. To determine whether your facility is 
affected by this action, you should carefully examine the applicability 
criteria in 40 CFR part 372, subpart B. Federal facilities are required 
to report under Section 6(a) and (b) of Executive Order 14096 (88 FR 
25251, April 21, 2023), titled ``Revitalizing Our Nation's Commitment 
to Environmental Justice for All.'' If you have questions regarding the 
applicability of this action to a particular entity, consult the person 
listed under FOR FURTHER INFORMATION CONTACT.

B. What action is the Agency taking?

    EPA is proposing to add 16 individually listed per- and 
polyfluoroalkyl substances (PFAS) and 15 PFAS categories to the TRI 
list of toxic chemicals subject to reporting under section 313 of the 
Emergency Planning and Community Right-to-Know Act (EPCRA) and section 
6607 of the Pollution Prevention Act (PPA). The proposed PFAS chemical 
categories are comprised of an acid, associated salts, associated acyl/
sulfonyl halides, and an anhydride. EPA is proposing to set a 
manufacturing, processing, and otherwise use reporting threshold of 100 
pounds for each individually listed PFAS and PFAS category being 
proposed for listing by this rulemaking and to designate all PFAS 
listed under this action as chemicals of special concern. EPA also 
proposes to reclassify some individually-listed PFAS previously added 
to the TRI by sections 7321(b) and (c) of the National Defense 
Authorization Act for Fiscal Year 2020 (NDAA) as part of the proposed 
PFAS chemical categories. Doing so would align such listings with the 
approach provided for the candidate additions proposed in this 
rulemaking. This would change these chemicals from being individually 
listed to being part of the applicable chemical category. Finally, EPA 
also addresses what events may trigger the automatic addition of PFAS 
to the TRI list pursuant to the framework established by the NDAA 
section 7321(c).

C. What is the Agency's authority for taking this action?

    EPA is taking this action pursuant to EPCRA sections 313(d) and 328 
(42 U.S.C. 11023(d) and 11048), and section 7321(d) of the FY2020 NDAA 
(Pub. L. 116-92, section 7321). EPCRA is also referred to as Title III 
of the Superfund Amendments and Reauthorization Act of 1986. EPCRA 
section 313 is also

[[Page 81777]]

referred to as the Toxics Release Inventory (TRI).
1. EPCRA Authorities
    EPCRA section 313 requires owners/operators of certain facilities 
that manufacture, process, or otherwise use listed toxic chemicals in 
amounts above reporting threshold levels to report their facilities' 
environmental releases and other waste management information on such 
chemicals annually. These facility owners/operators must also report 
pollution prevention and recycling data for such chemicals, pursuant to 
section 6607 of the PPA (42 U.S.C. 13106).
    Under EPCRA section 313(c), Congress established an initial list of 
toxic chemicals subject to EPCRA toxic chemical reporting requirements 
that was comprised of 308 individually listed chemicals and 20 chemical 
categories. EPCRA section 313(d) authorizes EPA to add or delete 
chemicals from the list and sets criteria for these actions. EPCRA 
section 313(d)(2) states that EPA may add a chemical to the list if any 
of the listing criteria in EPCRA section 313(d)(2) are met. Therefore, 
to add a chemical, EPA must determine that at least one criterion is 
met, but need not determine whether any other criterion is met. 
Conversely, to remove a chemical from the list, EPCRA section 313(d)(3) 
dictates that EPA must determine that none of the criteria in EPCRA 
section 313(d)(2) are met. The listing criteria in EPCRA section 
313(d)(2)(A) through (C) are as follows:
    <bullet> The chemical is known to cause or can reasonably be 
anticipated to cause significant adverse acute human health effects at 
concentration levels that are reasonably likely to exist beyond 
facility site boundaries as a result of continuous, or frequently 
recurring, releases.
    <bullet> The chemical is known to cause or can reasonably be 
anticipated to cause in humans: cancer or teratogenic effects, or 
serious or irreversible reproductive dysfunctions, neurological 
disorders, heritable genetic mutations, or other chronic health 
effects.
    <bullet> The chemical is known to cause or can be reasonably 
anticipated to cause, because of its toxicity, its toxicity and 
persistence in the environment, or its toxicity and tendency to 
bioaccumulate in the environment, a significant adverse effect on the 
environment of sufficient seriousness, in the judgment of the 
Administrator, to warrant reporting under this section.
    EPA often refers to the EPCRA section 313(d)(2)(A) criterion as the 
``acute human health effects criterion;'' the EPCRA section 
313(d)(2)(B) criterion as the ``chronic human health effects 
criterion;'' and the EPCRA section 313(d)(2)(C) criterion as the 
``environmental effects criterion.'' EPA published a statement in the 
Federal Register of November 30, 1994 (59 FR 61432) (FRL-4922-2)) 
clarifying its interpretation of the EPCRA section 313(d)(2) and (d)(3) 
criteria for modifying the EPCRA section 313 list of toxic chemicals.
2. FY 2020 NDAA Authorities
    The FY 2020 NDAA provides several avenues for PFAS to be added to 
the TRI. Section 7321(b) of the FY 2020 NDAA, entitled ``Immediate 
Inclusion,'' provides that specific PFAS shall be deemed included in 
the TRI beginning January 1 of the calendar year following the date of 
enactment of the NDAA. Section 7321(c) of the FY 2020 NDAA, titled 
``Inclusion following Assessment,'' provides that PFAS shall be added 
to the TRI beginning January 1 of the year after the date on which 
certain events occur including the date on which the Administrator 
finalizes a toxicity value for a PFAS. These events include the 
following: EPA finalizing a toxicity value for a PFAS; including a PFAS 
in a Significant New Use Rule (SNUR) issued under the Toxic Substances 
Control Act (TSCA) (15 U.S.C. 2601 et seq.) or addition to an existing 
SNUR; and designating a PFAS as active on the TSCA Chemical Substance 
Inventory (TSCA Inventory). Section 7321(d) of the FY 2020 NDAA, in 
turn, requires EPA to determine within two years of the date of 
enactment of the FY 2020 NDAA whether certain PFAS (including classes) 
meet any of the listing criteria of EPCRA section 313(d)(2). As stated 
in Section 7321(d)(2) of the FY 2020 NDAA, the PFAS for which EPA must 
make such determinations include 15 PFAS described by name, each PFAS 
or class of PFAS for which a method to measure levels in drinking water 
has been validated by the Administrator, and each PFAS or class of PFAS 
that is used to manufacture fluorinated polymers, as determined by the 
Administrator. Section 7321(d)(3) of the FY 2020 NDAA requires that 
those PFAS that EPA determines meet the EPCRA section 313(d)(2) listing 
criteria be added to the EPCRA section 313 toxic chemical list within 
two years of such determination.

D. What are the estimated incremental impacts of this action?

    EPA prepared an economic analysis for this action titled, 
``Economic Analysis for the Addition of Certain Per- and 
Polyfluoroalkyl Substances; Community Right-to-Know Toxic Chemical 
Release Reporting; Proposed Rule (RIN 2070-AL03)'' (Ref. 1), which 
presents an analysis of the costs of the proposed addition of 16 
individually listed PFAS and 15 categories of PFAS identified in this 
document to the TRI list of chemicals. This economic analysis is 
available in the docket and is summarized here.
    EPA estimates that this action would result in an additional 356 to 
1,110 TRI reporting forms (i.e., Form Rs) being filed annually. EPA 
estimates that the costs of this action will be approximately between 
$2,114,886 and $6,594,234 in the first year of reporting and 
approximately $1,007,093 and $3,140,123 in the subsequent years. In 
addition, EPA has determined that, of the 277 to 865 small businesses 
affected by this action, none are estimated to incur annualized cost 
impacts of more than 1% of revenues. Thus, this action is not expected 
to have a significant adverse economic impact on a substantial number 
of small entities as further discussed in Unit X.C.

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

1. Submitting CBI
    Do not submit CBI to EPA through https://www.regulations.gov or 
email. If you wish to include CBI in your comment, please follow the 
applicable instructions at https://www.epa.gov/dockets/commenting-epa-dockets#rules and clearly mark the part or all of the information that 
you claim to be 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 and/or 40 CFR part 703, as applicable.
2. Tips for Preparing Your Comments
    When preparing and submitting your comments, see the commenting 
tips at https://www.epa.gov/dockets/commenting-epa-dockets.

II. Background

A. What are ``PFAS''?

    PFAS are synthetic organic compounds that do not occur naturally in 
the environment. PFAS typically contain a linear or branched alkyl 
carbon chain on which the hydrogen atoms have been partially (i.e., 
polyfluorinated) or completely (i.e., perfluorinated) replaced by 
fluorine atoms. In general, the strong carbon-

[[Page 81778]]

fluorine bonds of PFAS make them resistant to degradation and thus 
highly persistent in the environment (Ref. 2, 3, 4); though, some PFAS 
(e.g., certain perfluorobutanesulfonyl fluoride and 
perfluorobutanesulfonic anhydride in the case of 
perfluorobutanesulfonic acid (PFBS)), are known to become more toxic as 
they degrade in the environment. Some of these chemicals have been used 
for decades in a wide variety of consumer and industrial products (Ref. 
2, 3, 4). Some PFAS have been detected in humans and wildlife 
indicating that at least some PFAS have the ability to bioaccumulate 
(Ref. 2, 4). Because of the widespread use of PFAS in commerce and 
their tendency to persist in the environment, most people in the United 
States have been exposed to PFAS (Ref. 3, 5, 6). PFAS can accumulate in 
humans and remain in the human body for long periods of time (e.g., 
months to years) (Ref. 3, 4); several PFAS have been detected in human 
blood serum (Ref. 3, 4, 5, 6).
    Section 7321 of the NDAA does not define ``PFAS.'' Elsewhere in the 
NDAA, PFAS are defined for purposes specific to the applicable section. 
For example, in section 332, PFAS are defined as ``man-made chemicals 
with at least one fully fluorinated carbon atom.'' Beyond the NDAA, 
various scientific bodies and regulatory agencies--such as the European 
Chemical Agency (ECHA) and the Swedish Chemicals Agency--are aligned 
with the Organization of Economic Co-operation and Development (OECD) 
(Ref. 7, 8) in defining PFAS using broad, inclusive definitions.
    Because the FY2020 NDAA does not provide a complete list of the 
PFAS that EPA must consider for inclusion in the TRI, EPA used a 
structural definition of PFAS being used for other chemical regulatory 
activities at EPA (e.g., TSCA section 8(a)(7) Reporting and 
Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl 
Substances final rule (hereafter, the ``TSCA PFAS Data Reporting 
Rule'') (88 FR 70516) (Ref. 2) for the purpose of scoping chemicals for 
this proposed rule. Thus, for purposes of identifying candidates for 
this proposed TRI listing of PFAS, PFAS is defined to include chemicals 
that contain at least one of these three structural moieties:

R-(CF2)-CF(R')R'', where both the CF2 and CF moieties are saturated;
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.

    EPA notes that this definition may not be identical to other 
definitions of PFAS used within EPA and/or by other organizations. The 
term ``PFAS'' has been used broadly by many organizations for their 
individual research and/or regulatory needs. As an example, the 
definition that EPA applied for this proposal is a more precise 
characterization than the very broad and inclusive definitions provided 
in other sections of the NDAA (described above). Various programs or 
organizations have distinct needs or purposes apart from EPA's Office 
of Chemical Safety and Pollution Prevention (OCSPP). Therefore, 
different definitions of the term ``PFAS'' may be appropriate for other 
purposes--some are meant to describe the broader universe of PFAS as a 
whole and others are intended to be regulatorily- and context-specific. 
The Agency notes that this perspective, that different users may have 
different decision contexts or needs and no single PFAS 
characterization or definition meets all needs, is shared by many other 
organizations, including OECD (see page 29, (Ref. 7)).
    EPA recognizes that there were various options for applying a 
definition of ``PFAS'' for scoping purposes and acknowledges that there 
may be other rules or programs that apply different definitions to meet 
their own needs. Notably, use of the definition described in this unit 
aligns this proposal with other regulatory actions by OCSPP, such as 
the TSCA PFAS Data Reporting Rule (Ref. 2), thereby providing a 
consistent understanding across TSCA and TRI for purposes of assessing 
hazard information. Further, aligning the TRI definition with the 
definition being used for various TSCA activities helps ensure that 
this TRI rulemaking focuses on chemicals most likely to be active in 
commerce and thus are more likely to be manufactured, processed, and/or 
otherwise used by facilities in quantities that may trigger TRI 
reporting requirements. As indicated previously, the TSCA PFAS Data 
Reporting Rule provides additional discussion of this definition and 
the explanation for its use for certain regulatory actions (Ref. 2).

B. How did EPA identify PFAS for purposes of identifying PFAS to be 
added under 7321(d) of the NDAA?

    The first step EPA took in identifying PFAS as required by section 
7321(d) of the NDAA was to create a list of all potential chemical 
candidates to consider. Section 7321(d)(2)(A) through (O) provides a 
list of PFAS for which the Administrator must determine whether any of 
the EPCRA 313(d)(2) criteria are met. Paragraphs (A) through (M) of 
section 7321(d)(2) identify specific PFAS by name and/or an identifier 
(typically Chemical Abstracts Service Registry Number (CASRN)). 
Paragraph (N) identifies any PFAS for which a method to measure levels 
in drinking water has been validated by the Administrator. At the time 
of the NDAA's enactment, EPA had approved two methods to analyze 
drinking water samples to ensure compliance with regulations that 
include PFAS, Method 533 and 537.1. Together, Method 533 and Method 
537.1 identify 29 PFAS, of which 23 are distinct from the PFAS 
identified in paragraphs (A) through (M).
    Paragraph (O) generally indicates that EPA must consider for 
listing any PFAS used to manufacture fluorinated polymers, as 
determined by the Administrator. A polymer is a chemical substance 
consisting of molecules characterized by the sequence of one or more 
types of monomer units. A monomer is a chemical substance that is 
capable of forming covalent bonds with two or more like or unlike 
molecules. A monomer reacting with other monomer molecules forms a 
larger polymer chain or network in a process called polymerization. 
Accordingly, a fluorinated polymer is a polymer that includes fluorine.
    To determine which PFAS qualify as PFAS used to manufacture 
fluorinated polymers pursuant to paragraph (O), EPA relied on the 
CompTox Chemicals Dashboard (CompTox) (an EPA web-based application 
that provides public access to data on more than 1.2 million chemicals) 
(comptox.epa.gov/dashboard) (Ref. 9). CompTox includes a broad list of 
PFAS chemicals (see the Dashboard chemical list ``EPA PFAS chemicals 
without explicit structures,'' available at https://comptox.epa.gov/dashboard/chemical-lists/PFASDEV1) (Ref. 10), which includes 
fluorinated polymers. EPA downloaded this list and then, to identify 
polymers, filtered out likely non-polymers by first removing any 
chemicals listed as ``compounds with,'' ``reaction products,'' or 
``poly(difluoromethane)-R''. Such substances would not be characterized 
as ``fluorinated polymers.'' The remaining chemicals were identified as 
potential fluorinated polymers as per the language provided by 
paragraph (O).
    Then, of the remaining potential fluorinated polymers, EPA 
determined whether a PFAS was used to manufacture the polymer. EPA 
reviewed the preferred name or other associated synonym that provided 
descriptive information of the molecular structure

[[Page 81779]]

of the polymer or information about the chemicals used to create the 
respective polymer. These descriptive synonyms were used to identify 
fluorinated substructures of the polymer and/or each fluorinated 
substance used to make the polymer (i.e., EPA identified each component 
of a polymer that is a fluorinated chemical based on its name). For 
example, for the polymer in CompTox labeled ``POLYFLGSID_897590'' 
(CASRN 68586-13-0), its constituent monomers were not apparent from 
that name. However, its synonym as registered within CompTox was ``2-
Propenoic acid, 2-[[(heptadecafluorooctyl)sulfonyl]methylamino]ethyl 
ester, polymer with 2-[methyl[(nonafluorobutyl)sulfonyl]amino]ethyl 2-
propenoate, [alpha]-(2-methyl-1-oxo-2-propenyl)-[omega]-
hydroxypoly(oxy-1,2-ethanediyl), [alpha]-(2-methyl-1-oxo-2-propenyl)-
[omega]-[(2-methyl-1-oxo-2-propenyl)oxy]poly(oxy-1,2-ethanediyl), 2-
[methyl[(pentadecafluoroheptyl)sulfonyl]amino]ethyl 2-propenoate, 2-
[methyl[(tridecafluorohexyl)sulfonyl]amino]ethyl 2-propenoate and 2-
[methyl[(undecafluoropentyl)sulfonyl]amino]ethyl 2-propenoate,'' which 
allowed EPA to identify five constituent monomers and determine whether 
any met the definition of PFAS used for purposes of scoping for this 
rule. EPA then identified as many unique CASRNs for these individual 
monomers as possible and compared them to the PFAS already on the TRI 
list as well as those already under review or subject to review via 
another requirement of the NDAA (e.g., any PFAS for which a method to 
measure levels in drinking water has been validated by the 
Administrator that are already on the TRI list, NDAA section 
7231(d)(2)(N)). Additionally, EPA removed any chemicals identified via 
this process that did not meet the TSCA PFAS Data Reporting Rule's 
structural definition of PFAS (Ref. 2) (see Unit II.A.).
    NDAA section 7321(d)(2) uses the term ``including'' as a preface to 
the PFAS described by paragraphs (A) through (O). EPA thus interprets 
paragraphs (A) through (O) as examples of the larger universe of PFAS 
this section requires EPA to consider. Accordingly, EPA also considered 
additional PFAS beyond those described by paragraphs (A) through (O). 
To assist in identifying such chemicals, EPA applied the definition of 
PFAS (see Unit II.A.) and looked for chemicals that fit that 
definition. Additionally, EPA considered its previously articulated 
position on the use of manufacturing volume thresholds (e.g., 58 FR 
63500, December 1, 1993) (FRL-4904-6)) and, as in past chemical reviews 
(e.g., 59 FR 61432, November 30, 1994) (FRL-4922-2) (Ref. 11), applied 
a screening process to screen out PFAS for which no reports would be 
expected to be submitted in order to focus its listing actions on 
chemicals for which TRI reporting is anticipated. TRI previously used 
Chemical Data Reporting (CDR) data to help identify chemicals for which 
TRI reporting would be unlikely due to no reports having been submitted 
to CDR for any such chemicals. However, because the CDR reporting 
threshold (either 25,000 pounds or 2,500 pounds, depending on whether 
certain TSCA actions apply to the given chemical substance) is above 
the 100-pound threshold being proposed here, EPA determined it more 
appropriate to consider a broader universe of chemicals than just those 
identifiable using the CDR production volume screen.
    To assist EPA in identifying PFAS for which TRI reporting could be 
anticipated, the Agency considered PFAS categorized as reportable 
pursuant to the TSCA PFAS Data Reporting Rule (Ref. 2), given that 
rule's focus on manufactured PFAS. (For more discussion on the proposed 
reporting threshold for this action, see Unit V.). PFAS reportable 
pursuant to the TSCA PFAS Data Reporting Rule are primarily 
characterized as ``active'' in commerce pursuant to the TSCA Inventory, 
though the TSCA PFAS Data Reporting Rule, includes chemical substances 
beyond those on the TSCA Inventory (e.g., PFAS with a low-volume 
exemption). TRI reporting on such chemicals could occur since they may 
be manufactured, processed, and/or otherwise used. Thus, it is 
appropriate to include such chemicals for consideration for purposes of 
this rule. Additionally, EPA considered chemicals that might not be 
subject to the TSCA PFAS Data Reporting Rule, but which might 
nevertheless be possible listing candidates for TRI (e.g., PFAS 
regulated pursuant to the Federal Insecticide, Fungicide, and 
Rodenticide Act).
    EPA did not screen out (i.e., remove as a candidate) any PFAS 
listed in NDAA section 7321(d)(2)(A) through (O) based on TSCA 
Inventory status. EPA did, however, remove any chemicals with CBI 
claims related to their identity to focus on chemicals for which the 
Agency could publicly provide hazard data to support listing. EPCRA 
section 313(d)(2) requires EPA to support proposed listings with 
``sufficient evidence.'' Consequently, it could be difficult for the 
public to review and comment on such evidence where the public is not 
aware of the identity of the chemical. Further, it would take 
additional Agency resources to ensure that such information is provided 
in a manner that protects the privileged information pursuant to the 
applicable CBI claim. However, current CBI claims concerning identity 
of a given PFAS are being reviewed by EPA. Further, additional reviews 
will be triggered by forthcoming CDR filings as well as reporting being 
required pursuant to the TSCA section 8(a)(7) PFAS Data Reporting Rule. 
EPA will consider PFAS whose identities are disclosed due to this 
review process as candidates for potential future additions.
    For chemicals other than the NDAA section 7321(d)(2)(A) through (O) 
candidates and except for purposes of identifying salts associated with 
acids being proposed for listing, EPA generally removed from 
consideration PFAS which were not active on the TSCA Inventory. The 
Agency also removed chemicals with CBI claims related to their 
identity, when locating hazard information. By excluding chemicals with 
CBI claims related to their identity for purposes of identifying hazard 
information, EPA focused on publicly available literature with which to 
support the TRI listing process. Please see Unit IV. for details on CBI 
claims related to potential category chemicals.
    Though EPA generally used the TSCA Inventory as a means to screen 
out chemicals, aside from the specifically mentioned chemicals in the 
NDAA, the Agency also considered certain chemicals that are not on the 
TSCA Inventory (those that are regulated under statutes other than TSCA 
due to their uses). For example, TSCA does not regulate uses of a 
chemical as a pesticide or drug. EPCRA does not limit the scope of 
reportable chemical substances by use of the chemical. Thus, EPA 
determined it appropriate not to apply the TSCA Inventory screening 
process where EPA is aware of the manufacture of a chemical even though 
it is not on the TSCA Inventory. For such chemicals, the Agency 
considered available toxicity data to determine if there is sufficient 
evidence to support a TRI listing. Accordingly, EPA is including 
certain pesticides registered with the EPA (i.e., broflanilide, 
hexaflumuron, pyrifluquinazon, and tetraconazole) as well as certain 
pharmaceutical chemicals for which the Agency anticipates TRI reporting 
would occur were the Agency to list such chemicals. Relatedly, EPA is 
also proposing to clarify that pesticide

[[Page 81780]]

registrations that establish final toxicity values for PFAS constitute 
finalization of a toxicity value by the Administrator that result in 
the automatic addition of the PFAS to the TRI (see Unit VII.). This 
approach captured a large universe of PFAS for which EPA screened for 
literature that could support a TRI listing pursuant to the ECPRA 
section 313(d)(2) criteria. For PFAS for which such literature was 
located, the Agency produced either TRI listing support documents, as 
provided in the docket, or relied on assessments that had been or are 
being produced for reasons separate from this rulemaking.
    Additionally, EPA explored additional means for identifying PFAS, 
as well as other chemicals, as candidates for TRI listing, and the 
Agency is soliciting comment on this approach as well as other 
approaches that it might take to expand its process for identifying and 
proposing chemicals for addition to the TRI list. To this end, the TRI 
Program queried the ECOTOX Knowledgebase (ECOTOX) (Ref. 12) and the EPA 
Health Assessment Workspace Collaborative (EPA HAWC) project for the 
Systematic Evidence Map for Over One Hundred and Fifty Per- and 
Polyfluoroalkyl Substances (PFAS) publication (PFAS 150 (2022) project 
for shorthand) (Ref. 13, 14).
    ECOTOX is a web-based application for locating single chemical 
toxicity data for aquatic life, terrestrial plants, and wildlife. EPA 
created and maintains ECOTOX to address the need for assembled 
environmental toxicity data as the number of chemicals introduced into 
commerce continues to grow and regulatory mandates require safety 
assessments for a greater number of chemicals. ECOTOX is currently the 
world's largest compilation of curated ecotoxicity data, providing 
support for assessments of chemical safety and ecological research 
through systematic and transparent literature review procedures. ECOTOX 
utilizes well-established standard operating procedures with a strict 
screening pipeline and process to only include applicable data from 
several well-recognized databases (e.g. Scopus, ProQuest, PubAg, Web of 
Science).
    Comprehensive chemical-based literature searches are conducted by 
experts in the field and the resulting citations are screened at title/
abstract level followed by manual full-text review. If a study passes 
pipeline screening at the title/abstract level, the full text is then 
manually reviewed to determine applicability for inclusion to ECOTOX 
and can be excluded for a number of reasons (Ref. 15). Inclusion 
criteria include: exposure to a single chemical (test substance) that 
can be unequivocally identified, test organism unequivocally identified 
and relevant for ecological assessments, reported exposure 
concentration(s) and duration, and inclusion of control(s). Exclusion 
reasons are, for example: lack of an appropriate description of study 
methods to determine test substance, test organism, exposure duration/
concentration; species relevant for human health hazard (rather than 
ecological hazard); or observational survey study; among other reasons 
(Ref. 15). Furthermore, many data fields are extracted for each study 
in ECOTOX that can serve as a metric for evaluation of study design, 
including: test method; dose; exposure sample number and duration; 
analytical methods and measurements; and experimental design. In 
addition to identification of studies through ECOTOX-specific 
literature searches, studies that EPA has reviewed with its systematic 
review process are also added to ECOTOX (i.e., for TSCA Risk 
Evaluations).
    EPA HAWC is a web-based application for developing environmental 
and human health assessments that promotes transparency, data 
usability, and understanding of the data and decisions supporting an 
assessment. EPA HAWC allows the data and decisions supporting an 
assessment to be evaluated and managed using a collection of features 
that support methods including literature screening, study evaluation, 
and data extraction. EPA HAWC serves as a comprehensive landscape of 
study details and data supporting an assessment, and it serves as a 
public repository for the study quality decisions and extracted data 
used to support an assessment and provides rich, interactive visuals of 
the results both within and across the evidence (https://www.epa.gov/risk/health-assessment-workspace-collaborative-hawc). For EPA 
assessments that have used the EPA HAWC application to aid in support 
conducting those assessments, which include certain TSCA risk 
evaluations and IRIS and other ORD assessments, the system contains 
information on the collective, publicly available studies and data that 
were used in those assessments (https://hawc.epa.gov/assessment/public/
).
    Both ECOTOX and EPA HAWC are web-based applications that provide 
study quality evaluation and dose-response analysis, among other 
information, that can be analyzed as evidence for purposes of TRI 
chemical listing decisions. EPA HAWC differs from ECOTOX in that ECOTOX 
is a comprehensive Knowledgebase providing single chemical 
environmental toxicity data on aquatic and terrestrial species whereas 
EPA HAWC is an interactive, expert-driven, content management system 
for human health assessments. The Agency has identified one chemical 
((1H,1H, 2H, 2H-perfluorooctane sulfonic acid (6:2 FTS) (CASRN 27619-
97-2)) from a project within EPA HAWC, supporting data for the 
Systematic Evidence Map for Over One Hundred and Fifty Per- and 
Polyfluoroalkyl Substances (PFAS) (PFAS 150 (2022) project) (Ref. 14), 
that it determined would meet the TRI listing criteria. The Agency also 
identified one chemical (fulvestrant (CASRN 129453-61-8)) from ECOTOX 
that it determined would meet the TRI listing criteria. Because the 
content from each of these applications is produced by a consistent, 
published methodology based on generally accepted scientific 
principles, the Agency considers these applications to be appropriate 
tools for establishing sufficient evidence to support TRI listings 
analysis arising from information provided by these applications. More 
information is provided in Unit III. on the specific chemicals being 
proposed for listing, and EPA is, in Unit VIII., soliciting comment on 
using either or both of these applications, as well as other sources of 
such data, to support TRI listing decisions.
    The Agency is unaware of evidence on PFAS beyond the chemicals 
identified in this proposal that provide data sufficient for a TRI 
listing. EPA solicits comment on PFAS that the Agency might have 
overlooked where existing hazard literature would support a finding 
required by EPCRA section 313(d)(2) for a TRI chemical listing. In 
submitting literature for EPA's consideration, please refer to previous 
TRI chemical listing rule discussions for further guidance on how the 
Agency evaluates evidence in determining whether a study or data is 
sufficient for TRI listing, and whether the sufficient data support an 
EPCRA section 313 listing: see the Addition of 12 Chemicals final rule 
(87 FR 73475; November 30, 2022 (FRL-5927-02-OCSPP)) (Ref. 16) and the 
1994 chemical list expansion final rule (59 FR 61432; November 30, 1994 
(FRL-4922-2)) (Ref. 11).
    The Agency also searched for salts, acyl/sulfonyl halides, and 
anhydrides associated with PFAS identified for addition (as these are 
known hydrolysis precursors to the PFAS acid), as well as for PFAS 
added to TRI pursuant to previous activities (i.e., listed due to NDAA 
section 7321(b) and (c)). Salts, acyl/sulfonyl halides, and the 
anhydride associated with a given PFAS acid are

[[Page 81781]]

expected to have similar or higher toxicity (where the base comprising 
the salt [counter ion] presents an additional toxicity concern) to the 
associated acid. For purposes of describing these categories, EPA is 
proposing to list identified salts, acyl/sulfonyl halides, and the 
anhydride associated with each PFAS category. However, listing such 
chemicals is meant to be an illustrative rather than exhaustive list. 
Put another way, these proposed PFAS categories would include all of 
the salts, acyl/sulfonyl halides, and anhydride of the given PFAS acid 
rather than just those listed as examples (i.e., as proposed, the 
listing of an acid as a TRI category will automatically include 
associated salts, acyl/sulfonyl halides, and the anhydride, even if not 
explicitly mentioned).
    Any chemicals that were statutorily added to the TRI list pursuant 
to NDAA sections 7321(b) or (c), or already on the TRI list prior to 
the NDAA, are not candidates for this rulemaking due to their already 
being on the TRI list. However, EPA is proposing to change some such 
individual listings to category listings described in Unit III.B.
    Lastly, for some of the chemicals expressly described by 
7321(d)(2)(A) through (N), EPA's literature review did not reveal 
information sufficient to support a proposed listing. Accordingly, the 
Agency is not proposing to add such chemicals to the TRI list and as 
such, is not providing listing support documents to support TRI 
listings of any such chemicals. As indicated above, EPA is soliciting 
information related to chemicals in this proposal (for chemicals 
proposed for listing as well as for chemicals not identified as listing 
candidates). See Unit IV.A. for a list of these chemicals.

C. What is EPA's general rationale for proposing to list these PFAS 
pursuant to section 7321 of the NDAA?

    Based on EPA's review of the publicly available toxicity data, EPA 
has concluded that the PFAS proposed for addition to the EPCRA section 
313 toxic chemical list can reasonably be anticipated to cause adverse 
chronic human health effects at moderately low to low exposure doses 
and/or environmental effects at low concentrations. EPA concludes the 
data show that these PFAS have moderately high to high human health 
toxicity and/or are highly toxic to aquatic organisms. Further, some of 
the PFAS (e.g., certain perfluorobutanesulfonyl fluoride and 
perfluorobutanesulfonic anhydride in the case of 
perfluorobutanesulfonic acid (PFBS)) being proposed for listing are 
known to become more toxic as they degrade in the environment to other 
PFAS included in this proposed rule; in other words, some of the PFAS 
proposed for listing are known to be the source of transformation/
degradation products that are highly toxic. Therefore, EPA believes 
that the evidence is sufficient for listing all PFAS in this proposed 
rule (as described in Unit III.B. and C.) on the EPCRA section 313 
toxic chemicals list pursuant to EPCRA section 313(d)(2)(B) and/or (C).
    EPA has generally determined that it is not necessary or 
appropriate to perform an exposure assessment in order to consider 
listing TRI chemicals. EPA has considered the carcinogenicity and the 
potential for other serious or irreversible chronic human health 
effects as part of evaluating whether to list, but the Agency has not 
performed an exposure assessment pursuant to EPCRA section 313(d)(2)(B) 
(see 59 FR 61440-61442). EPCRA section 313 specifically requires that 
exposure be considered for listing a chemical pursuant to section 
313(d)(2)(A). The statute mandates that EPA consider whether ``a 
chemical is known to cause or can reasonably be anticipated to cause 
significant adverse acute human health effects at concentration levels 
that are reasonably likely to exist beyond facility site boundaries.'' 
However, statute is silent on the issue of exposure considerations for 
the section 313(d)(2)(B) and (C) criteria. The language of section 313 
does not prohibit EPA from considering exposure factors when making a 
finding under either section 313(d)(2)(B) or section 313(d)(2)(C), 
though such considerations are not required.
    Accordingly, generally EPA does not consider exposure for chronic 
human health effects or environmental effects as doing so is not 
statutorily required pursuant to EPCRA section 313(d)(2)(C) (see 59 FR 
61440-61442).
    Not only does EPCRA not require EPA to perform an exposure 
assessment for listings pursuant to section 313(d)(2)(B) or (C), but 
the intent of EPCRA also warrants forgoing exposure assessments for TRI 
listings. EPCRA section 313 charges EPA with collecting and 
disseminating information on releases, among other waste management 
data, so that communities can estimate local exposure and local risks; 
risks which can be significantly different than those which would be 
assessed using generic exposure considerations. The intent of EPCRA 
section 313 is to ensure that communities in which the releases occur 
have information needed both to consider the significance of risks and 
potential ways to address them. Similarly, TRI data helps the federal 
government, states, tribes, and local governments determine appropriate 
actions with regard to potential risks. This basic empowerment at 
national and local levels is a cornerstone of the right-to-know 
program.
    Therefore, in accordance with EPA's standard policy on the use of 
exposure assessments (see November 30, 1994 (59 FR 61432, FRL-4922-2) 
(Ref. 11)), an exposure assessment is neither necessary nor appropriate 
for determining whether any of the PFAS in this proposed rule meet the 
criteria of EPCRA section 313(d)(2)(B) or (C).
    EPA is also proposing to list certain categories of PFAS to include 
an acid and associated salts and acyl/sulfonyl halides. EPA's position 
is that salts will have at least the same hazard concerns as the 
associated acid. Categorizing salts with their associated acids will 
reduce the overall number of individual chemical listings while helping 
to ensure that TRI reporting is informative as it relates to the hazard 
for a given acid being proposed for listing. Further, the NDAA directs 
EPA to determine ``whether the substances and classes of substances'' 
described by section 7321(d) meet the TRI-listing criteria, which 
indicates congressional support for TRI to establish categories to help 
facilitate such reporting. Further, whereas ions were previously 
included on the TRI list pursuant to the NDAA section 7321(c), EPA is 
proposing to remove any individually-listed CASRNs of ions related to 
PFAS that are on the TRI list since the proposed PFAS acids are 
expected to dissociate into ions under normal environmental conditions. 
This is consistent with EPA's longstanding interpretation that adding 
an ion is effectively adding a category of related compounds that 
dissociate into the ion (see 59 FR 61432, 61460; November 30, 1994), 
regarding the listing of a nitrate compounds category, which 
encompasses reporting of the nitrate ion released) (Ref. 11)). 
Therefore, reporting for the PFAS categories in Unit III.B. and C 
includes PFAS ions because reporting on associated chemicals would be 
required. Explanations to support each proposed listing are provided in 
Unit III.

III. Technical Evaluation of the Toxicity of the PFAS Being Proposed 
for Addition

    EPA used a combination of existing Agency human health assessments 
and listing support documents specifically prepared for this action to 
evaluate the available data on human health effects and/or 
environmental effects associated with the PFAS being proposed for

[[Page 81782]]

listing, as identified by the process described in Unit III.B. to 
identify sufficient evidence to support chemical listings. Summaries of 
the available human health effects and environmental effects 
information that support listing these PFAS under EPCRA section 313 are 
provided in Unit IV. Where final EPA PFAS assessments are available, a 
brief summary of the assessment findings is provided.
    For PFAS without a final published hazard assessment, more detailed 
descriptions of the results and analyses supporting the listing support 
documents prepared for this action are included. See the support 
documents cited for each PFAS (also available in the rule docket) for 
more detailed information. Listing support documents created 
specifically for this rulemaking were developed with the TRI listing 
criteria in mind and are not intended to be used for purposes beyond 
this rulemaking. These support documents underwent review by at least 
three EPA scientists, one from the TRI program within the OCSPP, one 
from the Office of Research and Development (ORD), and one from the 
Office of Land and Emergency Management (OLEM). Additionally, review 
often included multiple additional scientists from the same office, and 
relevant assessments were also reviewed by scientists in the Office of 
Water (OW). The Agency is soliciting comment on its proposed 
determinations that there is sufficient evidence to establish that one 
or more of the criteria for listing under EPCRA section 313(d)(2) have 
been met.
    Additionally, EPA is proposing to use the following Agency 
databases that have evaluated and summarized hazard and dose-response 
literature as a basis for listing additional PFAS: EPA HAWC PFAS 150 
(2022) project and ECOTOX, as described in Unit II.B. For such proposed 
listings, the Agency is not producing separate listing support 
documents, but rather is relying on its technical expertise to review 
and describe data provided in these databases as providing sufficient 
evidence, based on scientific principles, to support such listings 
(i.e., these databases provide data on what toxicological effects are 
described by studies and at what doses). EPA considers this approach a 
more efficient means of informing additions to the TRI chemical list 
and solicits comment on this approach. Given that this would constitute 
a shift in relying on interpretation of extracted and curated data in a 
knowledge delivery platform (such as ECOTOX and projects in EPA HAWC) 
rather than a formal listing support document for TRI listing purposes, 
the Agency is soliciting comment on this approach before expanding its 
use for future listings. EPA notes that whether it generates a listing 
support document or relies on a formal hazard assessment, or it relies 
on interpreting curated data provided by a platform such as ECOTOX or 
projects in EPA HAWC, that it will review and describe the toxicity 
information so as to justify its finding of sufficient evidence to 
support a EPCRA 313(d)(2) listing criteria finding.
    Unit III.B. lists the PFAS categories proposed for listing, along 
with the relevant EPCRA section 313(d) listing criterion/criteria. Unit 
III.C. lists the individual PFAS that EPA is proposing to list under 
this action as well as the statutory basis (as provided for the PFAS 
categories) for doing so.

A. Which PFAS identified in section 7321(d)(A) through (N) are not 
proposed for listing?

    As noted in Unit II., the NDAA directed EPA to consider whether 
specific PFAS meet the EPCRA 313 listing criteria. Of the 39 unique 
PFAS identified in section 7321(d)(A) through (N) (i.e., either by 
chemical identifier or by virtue of its inclusion in a validated 
drinking water analytical method), 13 PFAS have already been added to 
the TRI list pursuant to NDAA section 7321(b)(1) or 7321(c)(1); 
therefore, these chemicals need not be considered for listing in this 
action. EPA then reviewed available information on the remaining 26 
PFAS identified in (A) through (N) to determine whether an EPCRA 313 
listing was warranted, finding that nine of those PFAS meet the EPCRA 
313 listing criteria (including as part of a category). Therefore, 17 
PFAS are not being proposed for listing on the TRI chemical list at 
this time (i.e., the chemicals specified in NDAA section 7321(d)(A) 
through (N) that are not included in this proposed action) are as 
follows, listed in order of inclusion under NDAA section 7321(d), with 
an explanation for why they are not being proposed with this action:
    <bullet> NDAA section 7321(d)(2)(B): 2,3,3,3-Tetrafluoro 2-
(1,1,2,3,3,3-hexafluoro)-2-(trifluoromethoxy) propanoyl fluoride (CASRN 
2479-75-6) and (C): 2,3,3,3-Tetrafluoro-2-[1,1,2,3,3,3-hexafluoro-2-
(trifluoromethoxy)propoxy]propanoic acid (CASRN 2479-73-4). Following 
the process described in Unit III.B., EPA did not locate literature 
that would support a listing for these chemicals, thus EPA is not 
proposing the addition of these chemicals.
    <bullet> NDAA section 7321(d)(2)(D): 4,8-dioxa-3H-perfluorononanoic 
acid--NDAA (ADONA) (CASRN 919005-14-4) and NDAA section 7321(d)(2)I 
(its 3 salts): ammonium 4,8-dioxa-3H-perfluorononanoate (CASRN 958445-
44-8), sodium 4,8-dioxa-3H-perfluorononanoate (NOCAS 892452; CASRN 
2250081-67-3), potassium 2,2,3-trifluoro-3-[1,1,2,2,3,3-hexafluoro-3-
(trifluoromethoxy)propoxy]propanoate (CASRN 1087271-46-2): Following 
the process described in Unit III.B., EPA concluded that there were 
very limited results for ADONA and its salts, which were insufficient 
to support listing on the TRI.
    <bullet> NDAA section 7321(d)(2)(M): Perfluoroheptanoic acid 
(PFHpA) (CASRN 375-85-9): Following the process described in Unit 
III.B., EPA identified potentially relevant literature evaluating human 
health effects of PFHpA. EPA has identified this chemical for further 
evaluation in future actions.
    <bullet> NDAA section 7321(d)(2)(N): Of the PFAS for which a method 
to measure levels in drinking water has been validated by EPA, EPA did 
not identify data to support a listing based on EPCRA criteria for the 
following-listed PFAS:
    <bullet> Perfluoro(2-ethoxyethane)sulfonic acid (PFEESA) (CASRN 
113507-82-7): Following the process described in Unit III.B., EPA did 
not locate results that would support a listing, thus EPA is not 
proposing the addition of this chemical.
    <bullet> Nonafluoro-3,6-dioxaheptanoic acid (NFDHA) (CASRN 151772-
58-6): Following the process described in Unit III.B., EPA did not 
locate results that would support a listing, thus EPA is not proposing 
the addition of this chemical.
    <bullet> N-methyl perfluorooctanesulfonamidoacetic acid (NMeFOSAA) 
(CASRN 2355-31-9): Following the process described in Unit III.B., EPA 
concluded that that there were very limited results for NMeFOSAA and 
its salts, which were unlikely to be sufficient for listing on the TRI. 
available data did not support a listing based on EPCRA criteria.
    <bullet> Perfluoropentanoic acid (PFPeA) (CASRN 2706-90-3): 
Following the process described in Unit III.B., EPA concluded that that 
there were very limited results for PFPeA and its salts, which were 
unlikely to be sufficient for listing on the TRI. available data did 
not support a listing based on EPCRA criteria.
    <bullet> Perfluoropentanesulfonic acid (PFPeS) (CASRN 2706-91-4): 
Following the process described in Unit III.B., EPA concluded that that 
there were very limited results for PFPeS and its salts, which were 
unlikely to be sufficient for

[[Page 81783]]

listing on the TRI. available data did not support a listing based on 
EPCRA criteria.
    <bullet> N-ethyl perfluorooctanesulfonamidoacetic acid (NEtFOSAA) 
(CASRN 2991-50-6): Following the process described in Unit III.B., EPA 
concluded that that there were very limited results for NEtFOSAA and 
its salts, which were unlikely to be sufficient for listing on the TRI. 
available data did not support a listing based on EPCRA criteria. 
However, note that we are requesting comment on this chemical as a 
precursor to PFOS (see Unit VII.I).
    <bullet> Perfluoroheptanesulfonic acid (PFHpS) (CASRN 375-92-8): 
Following the process described in Unit III.B., EPA concluded that 
available data did not support a listing based on EPCRA criteria. 
However, EPA did locate more data on this chemical than it did for the 
other chemicals in this list. A summary of EPA's findings on PFHpS is 
available in the docket (Ref. 17).
    <bullet> 1H,1H, 2H, 2H-Perfluorodecane sulfonic acid (8:2FTS) 
(CASRN 39108-34-4): Following the process described in Unit III.B., EPA 
concluded that that there were very limited results for 8:2FTS and its 
salts, which were unlikely to be sufficient for listing on the TRI. 
available data did not support a listing based on EPCRA criteria. Note 
that we are requesting comment on this chemical as a precursor to PFOA 
(see Unit VIII.).
    <bullet> 1H,1H, 2H, 2H-Perfluorohexane sulfonic acid (4:2FTS) 
(CASRN 757124-72-4): Following the process described in Unit III.B., 
EPA did not locate results that would support a listing; thus, EPA is 
not proposing the addition of this chemical.
    <bullet> Perfluoro-4-methoxybutanoic acid (PFMBA) (CASRN 863090-89-
5): Following the process described in Unit III.B., EPA concluded that 
that there were very limited results for PFMBA and its salts, which 
were unlikely to be sufficient for listing on the TRI. Available data 
did not support a listing based on EPCRA criteria.
    Additionally, one of the 18 PFAS that is identified in NDAA section 
7321(d)(2) that is already on the TRI list is being proposed to be 
changed from an individual listing to being incorporated into a 
category.
    <bullet> NDAA section 7321(d)(2)(I): Perfluorobutanesulfonate 
(CASRN 45187-15-3): This chemical is already on the TRI list; we are 
proposing it for removal as an individually-listed chemical because it 
is an anion for which reporting will occur based on the associated 
acid, perfluorobutanesulfonic acid (PFBS) (CASRN 375-73-5) see Unit 
II.C. for further discussion on the proposed removal of [an]ions.

B. What are the proposed chemical categories?

    This unit identifies the PFAS categories that are included in this 
proposed action. For a discussion on reporting for categories, please 
see Unit IV.
    For each of the proposed categories, EPA is including the acid and 
the associated salts, acyl/sulfonyl halides (where relevant), and 
anhydride (where relevant). Because the salts will dissociate under 
normal environmental conditions (Ref. 18) and the acyl/sulfonyl halides 
and anhydride will be converted to the acid in aqueous solutions (Ref. 
19), EPA posits that these other forms of the PFAS would be expected to 
have toxicity profiles comparable to the acid and could be anticipated 
to become the same primary chemical of the category (the PFAS acid) 
once in the environment. Given the general chemical relationship 
amongst the salts, acyl/sulfonyl halides, anhydride, and acid, such 
groupings of chemicals should therefore be reported to TRI as a 
chemical category.
    For example, 9-chlorohexadecafluoro-3-oxanone-1-sulfonic acid (9Cl-
PF3ONS) (CASRN 756426-58-1) is the acid of the proposed category 
including 9Cl-PF3ONS itself, as well as its associated salt, potassium 
9-chlorohexadecafluoro-3-oxanonane-1-sulfonate (CASRN 73606-19-6). Note 
that some categories include PFAS that are currently on the TRI list, 
but which EPA is proposing to categorize together as acid and salts. A 
discussion for each proposed chemical category and its EPCRA listing 
justification(s) follow the bulleted list. An ``*'' indicates that the 
parent compound is already on TRI; the parent compound is being listed 
here as a proposal to extend the given listing to associated salts, 
acyl/sulfonyl halides, and anhydride as part of a chemical category.
    The scopes of these particular PFAS categories are specific to the 
needs of the TRI reporting program and may not be identical to other 
potential categorizations or classifications for other EPA purposes. 
Further, the TRI PFAS categories are separate from ongoing efforts by 
EPA and others to define PFAS categories or ``classes'' for purposes of 
other regulatory activities as well as for research.
    The following are the list of chemical categories and reason for 
inclusion (For TRI Reporting):
    <bullet> 9-Chlorohexadecafluoro-3-oxanone-1-sulfonic acid (9Cl-
PF3ONS) (CASRN 756426-58-1), Salts, and Sulfonyl Halides Category, 
which is based on EPCRA 313(d)(2)(B) (Chronic Human Health) and 
313(d)(2)(C) (Effect on the Environment);
    <bullet> 11-Chloroeicosafluoro-3-oxaundecane-1-sulfonic acid (11Cl-
Pf3OUdS) (CASRN 763051-92-9), Salts, and Sulfonyl Halides Category, 
which is based on EPCRA 313(d)(2)(C) (Effect on the Environment);
    <bullet> Hexafluoropropylene oxide dimer acid (HFPO-DA, GenX) 
(CASRN 13252-13-6)*, Salts, and Acyl Halides Category, which is based 
on EPCRA 313(d)(2)(B) (Chronic Human Health);
    <bullet> Perfluorobutanesulfonic acid (PFBS), Salts, Sulfonyl 
Halides, and Anhydride Category (CASRN 375-73-5)*, which is based on 
EPCRA 313(d)(2)(B) (Chronic Human Health);
    <bullet> Perfluorobutanoic acid (PFBA) (CASRN 375-22-4)*, Salts, 
Acyl Halides, and Anhydride Category, which is based on 313(d)(2)(B) 
(Chronic Human Health);
    <bullet> Perfluorodecanoic acid (PFDA) (CASRN 335-76-2)*, Salts, 
Acyl Halides, and Anhydride Category, which is based on 313(d)(2)(B) 
(Chronic Human Health);
    <bullet> Perfluorododecanoic acid (PFDoA) (CASRN 307-55-1)*, Salts, 
Acyl Halides, and Anhydride Category, which is based on 313(d)(2)(B) 
(Chronic Human Health);
    <bullet> Perfluorohexanesulfonic acid (PFHxS) (CASRN 355-46-4)*, 
Salts, Sulfonyl Halides, and Anhydride Category; which is based on 
313(d)(2)(B) (Chronic Human Health);
    <bullet> Perfluorohexanoic acid (PFHxA) (CASRN 307-24-4)*, Salts, 
Acyl Halides, and Anhydride Category, which is based on 313(d)(2)(B) 
(Chronic Human Health);
    <bullet> Perfluorononanoic acid (PFNA) (CASRN 375-95-1)*, Salts, 
Acyl Halides, and Anhydride Category, which is based on 313(d)(2)(B) 
(Chronic Human Health);
    <bullet> 1H,1H,2H,2H-Perfluorooctane sulfonic acid (6:2 FTS) (CASRN 
27619-97-2), Salts, and Sulfonyl Halides Category, which based on 
313(d)(2)(B) (Chronic Human Health);
    <bullet> Perfluorooctanoic acid (PFOA) (CASRN 335-67-1)*, Salts, 
Acyl Halides, and Anhydride Category, which is based on 313(d)(2)(B) 
(Chronic Human Health);
    <bullet> Perfluorooctanesulfonic acid (PFOS) (CASRN 1763-23-1)*, 
Salts, Sulfonyl Halides, and Anhydride Category; which is based on 
313(d)(2)(B) (Chronic Human Health);
    <bullet> Perfluoropropanoic acid (PFPrA) (CASRN 422-64-0), Salts, 
Acyl Halides, and Anhydride Category, which is based

[[Page 81784]]

on 313(d)(2)(B) (Chronic Human Health); and
    <bullet> Perfluoroundecanoic acid (PFUnA) (CASRN 2058-94-8), Salts, 
Acyl Halides, and Anhydride Category, which is based on 313(d)(2)(B) 
(Chronic Human Health).
    The Agency has provided important endpoints in the following 
summary. For the full toxicological profile, please refer to the 
respective references.
1. 9-Chlorohexadecafluoro-3-oxanone-1-sulfonic acid (9Cl-PF3ONS) (CASRN 
756426-58-1), Salts, Sulfonyl Halides, and Anhydride Category
    a. Human health hazard assessment. This category would include all 
associated salts and sulfonyl halides including: potassium 9-
chlorohexadecafluoro-3-oxanonane-1-sulfonate (CASRN 73606-19-6). EPA 
found evidence of both serious or irreversible human health effects and 
environmental effects due to 9Cl-PF3ONS and its salts. EPA is proposing 
to list 9Cl-PF3ONS and any associated salts and sulfonyl halides as a 
single TRI category, as the salts would be expected to dissociate in 
aqueous solutions and the sulfonyl halides would be expected to be 
converted to 9Cl-PF3ONS in aqueous solutions. Therefore, the toxicity 
concerns for 9Cl-PF3ONS apply to all members in this category.
    Available animal data, along with supporting mechanistic data, 
indicate that the most sensitive targets of oral toxicity of 9Cl-PF3ONS 
are the liver and thyroid. Observations in available subchronic oral 
studies indicate that 9Cl-PF3ONS is hepatotoxic: In a 10-week drinking 
water study in female mice, increases in serum enzymes (e.g., ALT, 
AST), liver weights, and incidence of histopathological foci indicative 
of altered tissue architecture (e.g., hepatocytic vacuolization and 
ballooning) were observed at a lowest observed adverse effect level 
(LOAEL) of 0.003 mg/kg/day.
    A similar profile of liver injury was observed in a 56-day gavage 
study in male mice. Significant increases in liver weights and 
histopathological foci (e.g., focal inflammation, lipid droplets) were 
observed at a LOAEL of 0.2 mg/kg/day. At the next highest administered 
dose (0.9 mg/kg/day), serum ALT and ALP levels were elevated 3-fold and 
11-fold, respectively, and histopathological lesions indicated more 
severe foci of cellular injury (e.g., hepatocellular necrosis).
    In a 28-day subchronic study in rats, it was also determined that 
9Cl-PF3ONS had adverse effects on thyroid hormone economy (Ref. 20). 
Decreased serum T4 and T3 levels in males and females and thyroid 
follicular hyperplasia in females were observed at >=19 mg 9Cl-PF3ONS/
kg-day. Mechanistic studies support that 9Cl-PF3ONS could disrupt 
thyroid hormone homeostasis via direct binding to thyroid hormone 
receptors and the carrier protein transthyretin. Additionally, 
alterations in thyroid hormone levels and genes involved in the 
hypothalamic-pituitary-thyroid (HPT) axis were observed in zebrafish 
larva exposed to potassium 9Cl-PF3ONS.
    Lastly, another study used a population-based, quantitative in 
vitro to in vivo extrapolation approach and determined that 9Cl-PF3ONS 
disturbed lipid homeostasis in HepG2 cells (human hepatoma cell line 
used for in vitro hepatotoxicity studies) through enhancement of lipid 
accumulation and fatty acid [beta]-oxidation (Ref. 20).
    b. Ecological hazard assessment. Several studies that evaluated 
sub-lethal endpoints indicate that 9Cl-PF3ONS and its potassium salt 
can cause adverse health effects at very low concentrations. A multi-
generation chronic study with 180-day exposure of sexually mature 5-
month-old zebrafish identified a lowest effect concentration (LOEC) of 
0.005 mg/L for effects on growth, reproduction, and development; a NOEC 
was not identified; and, therefore, a maximal acceptable toxicant 
concentration (MATC) value could not be calculated.
    In another study with zebrafish (28-day exposure the calculated 
aquatic chronic MATC value for hepatic effects was 0.032 mg/L. 
Additionally, several studies have reported the effects of 9Cl-PF3ONS 
and its potassium salt on thyroid hormone disruption in fish. One study 
reported increased thyroxine (T4) but not 3,5,30-triiodothyronine (T3) 
in zebrafish embryos following 5-day exposure to F-53B, the primary 
component of which is 9Cl-PF3ONS. The authors also conducted an in 
silico molecular docking analysis and F-53B was found to fit into the 
binding pocket of zebrafish thyroid transport protein (TTR) in the 
correct orientation, and to form three hydrogen bonds.
    Another study found that chronic F-53B exposure in adult zebrafish 
increased T4 levels, decreased T3 levels and exhibited 
transgenerational thyroid hormone disrupting effects. In a chronic 
toxicity test with chinese rare minnow, whole body total and free 
3,5,30-triiodothyronine (T3) levels were significantly increased 
following exposure to F-53B for 4 weeks. Together, these studies 
indicate that 9Cl-PF3ONS and its potassium salt have the potential to 
cause thyroid hormone disruption effects (Ref. 21).
    There is substantive evidence that 9Cl-PF3ONS has the potential to 
bioaccumulate in organisms. The tissue specific kinetic 
bioconcentration factor (BCF) reported in one study ranged from 228-
2212 for female zebrafish and 473-4425 for male zebrafish, at 10 and 
100 [micro]g/l exposures. In another study by the same authors, the 
reported whole body kinetic BCF was 3,612 at the nominal 10 [micro]g/l 
exposure and 3,615 at the nominal 100 [micro]g/l exposure. Several 
observational studies have reported the detection of F-53B in aquatic 
organisms (Ref. 21).
    c. Conclusion. EPA believes there is sufficient evidence to list 
the 9Cl-PF3ONS, Salts, Sulfonyl Halides, and Anhydride category on the 
TRI pursuant to EPCRA section 313(d)(2)(B)(ii)(IV) for serious or 
irreversible adverse liver and thyroid effects of this substance, and 
pursuant to section 313(d)(2)(C)(iii) for its environmental toxicity 
and bioaccumulation.
2. 11-Chloroeicosafluoro-3-oxaundecane-1-sulfonic acid (11Cl-PF3OUdS) 
(CASRN 763051-92-9), Salts, Sulfonyl Halides, and Anhydride Category
    This category would include all associated salts and sulfonyl 
halides including: potassium 11-chloroeicosafluoro-3-oxaundecane-1-
sulfonate (CASRN 83329-89-9). EPA found evidence of serious 
environmental effects of 11Cl-PF3OUdS and its salts and sulfonyl 
halides. EPA is proposing to list 11Cl-PF3OUdS and its associated 
salts, sulfonyl halides, and anhydride as a single TRI category, as the 
salts would be expected to dissociate in aqueous solutions and the 
sulfonyl halides would be expected to be converted to 11Cl-PF3OUdS in 
aqueous solutions. Therefore, the toxicity concerns for 11Cl-PF3OudS 
apply to all members in this category.
    a. Ecological hazard assessment. 11 cL-PF3OUds showed a lethal 
effect in zebrafish larvae after a 7-day exposure [LC<INF>50</INF> 
<=0.8 mg/L~0.8ppm]. This value has been calculated by the conversion of 
~1.2[micro]M which was obtained from the linear dose-response curve for 
11cl-PF3OUdS. This nominal LC<INF>50</INF> of 0.8 mg/L suggests 
moderate to high concern for hazard upon acute exposure of aquatic 
organisms (i.e., fish) to 11cl-PF3OUdS, especially given that actual 
concentrations were likely lower than nominal (Ref. 22).
    Persistence in the environment is expected to be high for 11cl-
PF3OUdS and its potassium salt. In an aerobic biodegradation study 
using loam surface soils with ~22% moisture content at 24[deg]C, 
negligible degradation of 11cl-

[[Page 81785]]

PF3OUdS was observed after 105 days (Ref. 22).
    Available data suggest that 11cl-PF3OUdS may bioaccumulate 
significantly in aquatic species [e.g., a whole-body BCF of 9,800 L/kg* 
and whole-body bioaccumulation factor (BAF) of 14,000 L/kg was 
determined for 11cl-PF3OUdS in the experimental studies of Chinese rare 
minnows and black-spotted frogs, respectively. *Note that for the study 
with the Chinese rare minnows, animals were exposed to the mixture F-
53B, of which 11cl-PF3OUdS is a component. BCF (protein) was also 
determined to be 58,000 L/Kg (average) for 11cl-PF3OUdS in the 
experimental studies for rainbow trout] (Ref. 22).
    b. Conclusion. EPA believes there is sufficient evidence to list 
the 11cl-PF3OUdS, Salts, Sulfonyl Halides, and Anhydride category on 
the TRI pursuant to EPCRA section 313I)(d)(2)(C) for (iii) its toxicity 
and tendency to bioaccumulate in the environment data for this 
chemical.
3. Hexafluoropropylene Oxide Dimer Acid (HFPO-DA; Gen X) (CAS 13252-13-
6), Salts, and Acyl Halides Category
    This category would include all associated salts and acyl halides 
including: propanoyl fluoride, 2,3,3,3-tetrafluoro-2-
(heptafluoropropoxy)-] (HFPO-DAF) (CASRN 2062-98-8), ammonium 
perfluoro-2-methyl-3-oxahexanoate (also known as and currently TRI-
listed as hexafluoropropylene oxide dimer acid (HFPO-DA) ammonium salt) 
(CASRN 62037-80-3), potassium 2,3,3,3-tetrafluoro-2-
(heptafluoropropoxy)propanoate (CASRN 67118-55-2) and sodium 2,3,3,3-
tetrafluoro-2-(heptafluoropropoxy)propanoate (CASRN 67963-75-1).
    HFPO-DA was added to the TRI list automatically in January 2020 
pursuant to NDAA section 7321(b)(1)(F). EPA is proposing to list HFPO-
DA and its associated salts and acyl halides as a single TRI category, 
as the salts would dissociate in aqueous solutions and the acyl halides 
would be expected to be converted to HFPO-DA in aqueous solutions. 
Therefore, the toxicity concerns apply to all members in this category.
    a. Human health hazard assessment. A 2021 EPA human health 
assessment exists for HFPO-DA and its ammonium salt (i.e., GenX 
chemicals). Based on the available data, the liver was identified as 
the most sensitive target of HFPO-DA toxicity and a subchronic 
reference dose (RfD) of 3x10<SUP>-</SUP>\5\ mg/kg bw-day and a chronic 
RfD of 3x10<SUP>-</SUP>\6\ mg/kg bw-day was derived (Ref. 23).
    Other effects observed in rats and/or mice following HFPO-DA 
exposure included kidney toxicity (e.g., increased relative kidney 
weight), immune effects (e.g., antibody suppression), hematological 
effects (e.g., decreased red blood cell count, hemoglobin, and 
hematocrit), reproductive/developmental effects (e.g., increased early 
deliveries, placental lesions, changes in maternal gestational weight 
gain, and delays in genital development in offspring), and cancer 
(e.g., liver and pancreatic)) (Ref. 23). There is Suggestive Evidence 
of Carcinogenic Potential in humans for the oral route of exposure 
(Ref. 23).
    b. Conclusion. EPA believes there is sufficient evidence to list 
the HFPO-DA, Salts, and Acyl Halides category on the TRI pursuant to 
EPCRA section 313(d)(2)(B)(ii) for serious or irreversible reproductive 
dysfunctions and other chronic effects on the liver, development, 
hematological system, and immune system after oral exposure.
4. *Perfluorobutanesulfonic Acid (PFBS) (375-73-5), Salts, Sulfonyl 
Halides, and Anhydride Category
    This category would include all associated salts, sulfonyl halides, 
and anhydride including: perfluorobutanesulfonyl fluoride (CASRN 375-
72-4), potassium perfluorobutane sulfonate (CASRN 29420-49-3), 
perfluorobutanesulfonic anhydride (CASRN 36913-91-4), sodium 
nonafluorobutane-1-sulfonate (CASRN 60453-92-1), ammonium 
perfluorobutanesulfonate (CASRN 68259-10-9), bis(2-
hydroxyethyl)ammonium perfluorobutanesulfonate (CASRN 70225-18-2), 
lithium nonafluorobutane-1-sulfonate (CASRN 131651-65-5), 
tetrabutylphosphonium perfluorobutanesulfonate (CASRN 220689-12-3) and 
magnesium nonafluorobutanesulfonate (CASRN 507453-86-3). This category 
does not include ionic forms such as perfluorobutanesulfonate (CASRN 
45187-15-3), though any conversion of those ions into PFBS or 
associated salts would constitute manufacturing for purposes of EPCRA 
section 313 and must be considered towards the PFBS, Salts, Sulfonyl 
Halides, and Anhydride category reporting threshold. If the PFAS 
category reporting threshold is met, then the facility's releases and 
other waste activities for this category will include those of the ion. 
In April 2021, EPA published final human health toxicity values for 
PFBS and the related compound potassium perfluorobutanesulfonate (CASRN 
29420-49-3) (Ref. 24) therefore, these chemicals have already been 
added to the TRI chemical list pursuant to NDAA section 7321(c). EPA is 
now proposing to list PFBS, its associated salts, sulfonyl halides, and 
anhydride as a single TRI category, as the salts would be expected to 
dissociate in aqueous solutions and the sulfonyl halides and anhydride 
would be expected to be converted to PFBS in aqueous solutions. 
Therefore, the toxicity concerns for PFBS apply to all members in this 
category.
    a. Human health hazard assessment. Health outcomes evaluated across 
available studies included effects on the thyroid and developing 
offspring following oral exposure to PFBS. There was a small number of 
epidemiology studies per outcome, which had limitations including poor 
sensitivity resulting from low exposure levels. Similar patterns of 
decreases in thyroid hormones (i.e., total T3, total T4, and free T4) 
were observed in PFBS-exposed pregnant mice and gestationally exposed 
female mouse offspring at >=200 mg/kg-d and in nonpregnant adult female 
and adult male rats at >=62.6 mg/kg-d. These decreases were 
statistically significant (~20% in dams and ~50% in offspring), were 
shown to persist at least 60 days after gestational exposure in 
offspring and exhibited dose dependence (Ref. 24).
    In the only mouse developmental study, developmental effects and 
altered markers of female reproductive development or function were 
observed in female offspring after gestational PFBS exposure, including 
decreased body weight, delayed eye opening, delayed vaginal opening, 
altered estrous cyclicity (including prolonged diestrus), altered 
reproductive hormones (e.g., decreased estradiol and progesterone), and 
effects on reproductive organs (e.g., weight and ovarian morphology). 
Most effects were observed at >=200 mg/kg-d, with several changes noted 
at PND 60. Endpoints relating to pregnancy, survival, and fetal 
morphological alterations were unchanged in both rats and mice and 
endpoints relating to fertility were unchanged in parental rats and 
mice across the four available studies. Alterations in 
histopathological markers of fertility were observed in mouse 
offspring, though the reproductive function of those offspring was not 
tested. In other studies, developmental body weight changes in rat 
offspring were either unchanged or observed only at doses causing 
parental toxicity (Ref. 24).
    The PFBS toxicity assessment derived subchronic and chronic oral 
RfDs of 0.0009 mg/kg-day and 0.0003 mg/kg-

[[Page 81786]]

day, respectively, based on thyroid effects (Ref. 24).
    EPA found that PFBS and its associated salts are known to cause or 
reasonably anticipated to cause serious or irreversible chronic health 
effects to the thyroid, and to have serious or irreversible 
reproductive/developmental effects.
    b. Conclusion. EPA believes there is sufficient evidence to list 
the PFBS, Salts, Sulfonyl Halides, and Anhydride category on the TRI 
pursuant to EPCRA section 313(d)(2)(B)(ii)(IV) for serious or 
irreversible thyroid toxicity and reproductive/developmental effects.
5. * Perfluorobutanoic Acid (PFBA) (CASRN 375-22-4), Salts, Acyl 
Halides, and Anhydride Category
    This category would include all associated salts and acyl halides 
including: perfluorobutanoyl fluoride (CASRN 335-42-2), 
perfluorobutanoic anhydride (CASRN 336-59-4), heptafluorobutyryl 
chloride (CASRN 375-16-6), sodium perfluorobutanoate (CASRN 2218-54-4), 
potassium perfluorobutanoate (CASRN 2966-54-3), silver 
heptafluorobutyrate (CASRN 3794-64-7), ammonium perfluorobutanoate 
(CASRN 10495-86-0), rhodium(II) perfluorobutyrate dimer (CASRN 73755-
28-9). This category does not include ionic forms such as 
perfluorobutanoate (CASRN 45048-62-2), though any conversion of those 
ions into PFBA or associated salts (including via dissociation in 
aqueous solution) would constitute manufacturing for purposes of EPCRA 
section 313 and must be considered towards the PFBA, Salts, Acyl 
Halides, and Anhydride category reporting threshold.
    In December 2022, EPA published an IRIS assessment for PFBA and 
associated salts (CASRNs 10495-86-0, 2218-54-4, 2966-54-3, 45048-62-2) 
(Ref. 25); therefore, these chemicals have already been added to the 
TRI chemical list pursuant to NDAA section 7321(c). EPA is now 
proposing to list PFBA and its associated salts as a single TRI 
category, as the salts would be expected to dissociate in aqueous 
solutions and the acyl halides would be expected to be converted to 
PFBA in aqueous solutions. This rule is also proposing to add silver 
heptafluorobutyrate (CASRN 3794-64-7) to TRI as part of this category. 
While the IRIS assessment did not necessarily extend to non-alkali 
metal salts such as silver heptafluorobutyrate due to PFBA-independent 
toxicity contributors, the overall compound has at least the same 
toxicity of the associated acid, PFBA. The toxicity concerns for PFBA 
that support a TRI listing apply to all members in this category.
    a. Human health hazard assessment. The currently available evidence 
indicates hazards likely exist with respect to the potential for 
thyroid, liver, and developmental effects in humans, given sufficient 
PFBA exposure conditions. These judgments are based on data from short-
term (28-day exposure), subchronic (90-day exposure), and developmental 
(17-day gestational exposure) oral-exposure studies in rodents (Ref. 
25).
    A consistent and coherent pattern of thyroid effects including 
hormonal, organ weight, and histopathological changes were observed, 
generally at PFBA exposure levels >=30 mg/kg-day, although some notable 
effects were observed at 6 mg/kg-day. Consistent, dose-dependent 
decreases in total and free T4 were observed independent of any effect 
on TSH. Additionally, increased thyroid weights and increases in 
thyroid follicular hypertrophy were observed. Because of the 
similarities in the production and regulation of thyroid hormone 
homeostasis between rodents and humans, the effects in rodents were 
considered relevant to humans (Ref. 25).
    Across various studies, liver effects were generally seen at PFBA 
exposure levels >=30 mg/kg-day. The PFBA-induced effects were observed 
in two species (rats and mice), in males and females, and across 
multiple exposure durations (short-term, subchronic, and gestational). 
Consistent, coherent, dose-dependent, and biologically plausible 
effects were observed for increased liver weights and increased 
incidences of hepatic histopathological lesions. Supporting the 
biological plausibility and human relevance of these effects is 
mechanistic information that suggests non- peroxisome proliferator-
activated receptor alpha (PPAR[alpha]) mode of actions (MOAs) could 
explain some of the observed effects in exposed rodents and that 
observed effects might be precursors to clearly adverse health outcomes 
such as steatosis (Ref. 25).
    PFBA exposure caused delays in developmental milestones (days to 
eye opening and vaginal opening) without effects on fetal (pup) growth 
at >=175 mg/kg-day. The results demonstrate a constellation of effects 
affecting the developing organism that is internally coherent (within-
study) and consistent across related PFAS compounds, including PFBS, 
PFOA, and PFOS. These developmental effects are considered relevant to 
humans (Ref. 25).
    Based on liver and thyroid effects, the PFBA toxicity assessment 
derived an overall RfD of 1 x 10<SUP>-3</SUP> mg/kg-day.
    EPA found that PFBA and its associated salts are known to cause or 
can reasonably be anticipated to cause serious or irreversible chronic 
health effects to both endocrine and hepatic systems. The IRIS 
assessment found increased hepatocellular hypertrophy (liver), as well 
as decreased total T4 (thyroid). Available evidence also indicates that 
PFBA exposure during pregnancy or in utero likely causes developmental 
effects.
    b. Conclusion. EPA believes there is sufficient evidence to list 
the PFBA, Salts, Acyl Halides, and Anhydride category on the TRI 
pursuant to EPCRA section 313(d)(2)(B)(ii)(IV) for serious or 
irreversible endocrine, liver, and thyroid effects.
6. * Perfluorodecanoic acid (PFDA) (CASRN 335-76-2), Salts, Acyl 
Halides, and Anhydride Category
    This category would include all associated salts and acyl halides 
including: perfluorodecanoyl chloride (CASRN 307-38-0), ammonium 
perfluorodecanoate (CASRN 3108-42-7), sodium perfluorodecanoate (CASRN 
3830-45-3), and perfluorodecanoic anhydride (CASRN 942199-24-8).
    PFDA was added to the TRI list automatically in January 2020 
pursuant to NDAA section 7321(b)(1)(E). In July 2024, EPA published an 
IRIS assessment for PFDA and associated salts (CASRNs 3108-42-7 and 
3830-45-3), thereby causing these specific salts to be added to the TRI 
chemical list pursuant to NDAA section 7321(c). EPA is proposing to 
list PFDA and its associated salts and acyl halides as a single TRI 
category, as the salts are expected to dissociate in aqueous solutions 
and the acyl halides would be expected to be converted to PFDA in 
aqueous solutions. Therefore, the toxicity concerns of PFDA apply to 
all members in this category.
    a. Human health hazard assessment. In July 2024, EPA finalized its 
IRIS assessment for PFDA and related salts (ammonium perfluorodecanoate 
(PFDA NH4, CASRN 3108-42-7) and sodium perfluorodecanoate (PFDA-Na, 
CASRN 3830-45-3)) (Ref. 26). Overall, the available evidence indicates 
that PFDA exposure is likely to cause liver, immune, developmental, and 
male and female reproductive effects in humans, given sufficient 
exposure conditions. The review concludes that the available evidence 
indicates PFDA exposure is likely to cause adverse liver effects in 
humans based on concordant effects for increased liver weight, 
alterations in levels of serum biomarkers of liver injury (ALT, AST, 
ALP, bile salts/acids, bilirubin and blood proteins), and some

[[Page 81787]]

evidence of hepatocyte degenerative or necrotic changes that provide 
support for the adversity of PFDA-induced liver toxicity reported in 
rats and mice exposed to PFDA doses >=0.156 mg/kg-day (Ref. 26).
    The hazard identification judgement that PFDA exposure is likely to 
cause immunotoxicity, specifically immunosuppression, in humans, is 
based primarily on consistent evidence of reduced antibody responses 
from human epidemiological studies (three studies in children and one 
in adults) at levels of 0.3 ng/mL (median exposure in studies observing 
an adverse effect. Reduced antibody response is an indication of 
immunosuppression and may result in increased susceptibility to 
infectious disease (Ref. 27). The antibody results present a consistent 
pattern of findings that higher prenatal, childhood, and adult serum 
concentrations of PFDA were associated with suppression of at least one 
measure of the antivaccine antibody response to common vaccines in two 
well-conducted birth cohorts in the Faroe Islands and supported by a 
low confidence study in adults. An inverse association was observed in 
21 of 26 evaluations, with a minimum of a 2% decrease in antibody 
concentration per doubling of PFDA concentration at levels consistent 
with the general population in NHANES; six of these evaluations were 
statistically significant and exhibited a large magnitude of effect 
(i.e., >18% decrease in response). These associations were observed 
despite poor study sensitivity, which increases confidence in the 
findings (Ref. 26). Additionally, the results are consistent with 
evidence of an association between exposure to PFOS and PFOA and 
reduced antibody responses in human studies indicative of potential 
immunosuppression (Ref. 28, 29).
    PFDA is likely to cause developmental toxicity in humans. This 
conclusion is based on dose-dependent decreases in fetal weight in mice 
gestationally exposed to PFDA at doses >=0.5 mg/kg-day, and is further 
supported by evidence of decreased birth and childhood weight from 
studies of exposed humans in which PFDA was measured during pregnancy, 
primarily with median PFDA values ranging from 0.11 to 0.46 ng/mL. This 
conclusion is further supported by coherent epidemiological evidence 
for biologically related effects (e.g., decreased postnatal growth and 
birth length) (Ref. 26).
    A 28-day study in rats indicated that PFDA exposure is likely to 
cause adverse effects to the male reproductive system, based on 
alterations in sperm counts, testosterone levels, and male reproductive 
histopathology and organ weights at doses >=0.625 mg/kg-day. In the 
same study, PFDA was shown to decrease the number of days spent in 
estrus and increase the amount of time spent in diestrus in female rats 
at >=1.25 mg/kg-day. A continuous state of diestrus started at Day 21 
in female rats exposed to 2.5 mg/kg-day. In vitro and intraperitoneal 
studies corroborate the effects seen in male rodents and suggest that 
PFDA disrupts Leydig cell function, resulting in reduced 
steroidogenesis and testosterone (Ref. 26).
    The Agency derived a lifetime and subchronic oral RfD for noncancer 
effects of 2 x 10<SUP>-9</SUP> mg/kg-day based on immune and 
developmental effects (Ref. 26).
    b. Conclusion. EPA believes there is sufficient evidence to list 
the PFDA, Salts, Acyl Halides, and Anhydride category on the TRI 
pursuant to EPCRA section 313(d)(2)(B) for serious or irreversible 
reproductive dysfunctions and other chronic effects on the liver, 
development, and immune system.
7.* Perfluorododecanoic Acid (PFDoA) (CASRN 307-55-1), Salts, Acyl 
Halides, and Anhydride Category
    This category would include all associated salts and acyl halides 
including: ammonium tricosafluorododecanoate (CASRN 3793-74-6) and 
perfluorododecanoic anhydride (CASRN 1456735-80-0). PFDoA was added to 
the TRI list automatically in January 2020 pursuant to NDAA section 
7321(b)(1)(E). EPA is proposing to list PFDoA and its associated salts 
and acyl halides as a single TRI category, as the salts are expected to 
dissociate in aqueous solutions and the acyl halides would be expected 
to be converted to PFDoA in aqueous solutions. Therefore, the toxicity 
concerns of PFDoA apply to all members in this category.
    a. Human health hazard assessment. Available animal data indicate 
that the most sensitive target of oral toxicity of PFDoA in rats is the 
liver, with a systemic NOAEL of 0.1 mg/kg-day and a LOAEL of 0.5 mg/kg-
day based on increased liver weights in males and females. Toxicity to 
both the male and female reproductive systems has been observed in rats 
following oral exposure to PFDoA, including changes in serum hormone 
levels, histopathological changes in reproductive organs (various 
histopathological lesions were observed in the reproductive organs of 
male rats exposed to 2.5 mg/kg-day for 42 days (starting 14 days prior 
to mating)), and alterations in estrous cyclicity in female rats, with 
the most sensitive changes observed at doses as low as 0.2 mg/kg-day. 
The majority of female rats exposed to 2.5 mg/kg-day could not maintain 
a pregnancy with most dying due to pregnancy and/or delivery 
complications prior to scheduled sacrifice. Gestation and delivery 
indices were significantly lower at 2.5 mg/kg-day, with only \1/3\ of 
the surviving dams delivering live pups. In female reproductive organs, 
hemorrhage of the implantation site and/or congestion in the 
endometrium were detected in the uterus of all 7 females found dead or 
moribund at the end of the gestation period. Hemorrhage at the 
implantation site was also found in one female that did not deliver 
live pups (all pups were stillborn). In one litter, the number of 
normally delivered pups in the 2.5 mg/kg-day group was 16; however, two 
of them were found dead on nursing day 0. Although the other 14 pups 
survived to the end of the study, their body weights on PNDs 0, 1, and 
4 were markedly lower than those of the control group. Body weight in 
females in the main group was significantly decreased at 2.5 mg/kg/day 
through the gestation period (Ref. 30).
    b. Conclusion. EPA believes there is sufficient evidence to list 
the PFDoA, Salts, Acyl Halides, and Anhydride category on the TRI 
pursuant to EPCRA section 313(d)(2)(B)(ii)(I) and (IV) for serious or 
irreversible reproductive dysfunctions and liver effects.
8. * Perfluorohexanesulfonic Acid (PFHxS) (CASRN 355-46-4), Salts, 
Sulfonyl Halides, and Anhydride Category
    This category would include all associated salts and sulfonyl 
halides including: perfluorohexanesulfonyl fluoride (CASRN 423-50-7), 
potassium perfluorohexanesulfonate (CASRN 3871-99-6) (currently TRI-
listed as ``1-hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6-
tridecafluoro-, potassium salt''), lithium perfluorohexanesulfonate 
(CASRN 55120-77-9), ammonium perfluorohexanesulfonate (CASRN 68259-08-
5) (currently TRI-listed as ``1-hexanesulfonic acid, 
1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-, ammonium salt''), bis(2-
hydroxyethyl)ammonium perfluorohexanesulfonate (CASRN 70225-16-0) 
(currently TRI-listed as ``1-hexanesulfonic acid, 
1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafl'oro-, compd. with 2,2'-
iminobis[ethanol] (1:1)'', sodium perfluorohexanesulfonate (CASRN 
82382-12-5), and perfluorohexanesulfonic anhydride (CASRN 109065-55-6).

[[Page 81788]]

    PFHxS was added to the TRI list automatically in January 2020 
pursuant to NDAA section 7321(b)(1)(I). EPA is now proposing to list 
PFHxS and its associated salts and sulfonyl halides as a single TRI 
category, as the salts would be expected to dissociate in aqueous 
solutions and the sulfonyl halides would be expected to be converted to 
PFHxS in aqueous solutions. Therefore, the toxicity concerns for PFHxS 
apply to all members of this category.
    In July 2023, a draft IRIS toxicological review for PFHxS and 
related salts (potassium perfluorohexanesulfonate (CASRN 3871-99-6), 
ammonium perfluorohexanesulfonate (CASRN 68259-08-5), and sodium 
perfluorohexanesulfonate (CASRN 82382-12-5), as well as nonmetal and 
alkali metal salts of PFHxS) was released for public comment and is 
currently undergoing external peer review (Ref. 31).
    a. Human health hazard assessment. The draft IRIS assessment 
concludes that the evidence indicates PFHxS exposure is likely to cause 
immunotoxicity and thyroid toxicity in humans, given sufficient 
exposure conditions. The primary supporting evidence for immunotoxicity 
included consistent findings of decreased antibody responses to 
vaccination against tetanus or diphtheria in children (Ref. 31). The 
evidence for thyroid toxicity, specifically decreased thyroid hormones, 
is based primarily on a short-term study and two multigenerational 
studies in rats reporting a consistent and coherent pattern of hormonal 
changes at PFHxS exposure levels >=2.5 mg/kg-day. A consistent dose-
dependent decrease of T4, and to a lesser extent T3, in adult and 
juvenile rats, with a magnitude of effect (up to 70%) in the absence of 
effects in TSH was observed (with males being more sensitive). In 
addition, one multigenerational study reported increased incidence of 
minimal thyroid hypertrophy and moderate hyperplasia in male rats after 
PFHxS exposure. Due to the similarities in thyroid hormone production 
between rodents and humans, the effects in rodents were considered 
relevant to humans (Ref. 31).
    The Agency derived a lifetime and subchronic oral RfD for noncancer 
effects of 4 x 10<SUP>-10</SUP> mg/kg-day based on immune effects 
(decreased serum anti-tetanus antibody concentration in children) (Ref. 
31).
    b. Conclusion. EPA believes there is sufficient evidence to list 
the PFHxS, Salts, Sulfonyl Halides, and Anhydride category on the TRI 
pursuant to EPCRA section 313(d)(2)(B)(ii)(IV) for serious or 
irreversible chronic effects on the thyroid and immune system.
9. Perfluorohexanoic Acid (PFHxA) (CASRN 307-24-4), Salts, Acyl 
Halides, and Anhydride Category
    This category would include all associated salts and acyl halides 
including: perfluorohexanoic anhydride (CASRN 308-13-4), silver 
perfluorohexanoate (CASRN 336-02-7), perfluorohexanoyl fluoride (CASRN 
355-38-4), perfluorohexanoyl chloride (CASRN 335-53-5), sodium 
perfluorohexanoate (CASRN 2923-26-4), potassium undecafluorohexanoate 
(CASRN 3109-94-2), and ammonium perfluorohexanoate (CASRN 21615-47-4). 
In April 2023, EPA finalized a toxicity value for PFHxA and related 
salts (specifically, ammonium perfluorohexanoate and sodium 
perfluorohexanoate) (Ref. 32). Accordingly, PFHxA and those salts 
specified by CASRN were automatically added to the TRI chemical list as 
of January 1, 2024, pursuant to the NDAA section 7321(c)(1)(A)(i). EPA 
is now proposing to list PFHxA and its associated salts and acyl 
halides as a single TRI category, as the salts would be expected to 
dissociate in aqueous solutions and the acyl halides would be expected 
to be converted to PFHxA in aqueous solutions. This rule is also 
proposing to add non-alkali metals including silver perfluorohexanoate 
(CASRN 336-02-7) to this category. The IRIS assessment did not 
necessarily extend to non-alkali metal salts such as silver 
perfluorohexanoate. Due to PFHxA-independent toxicity contributors, the 
metal portion of the salt may present additional toxicity concerns 
(e.g., a mercury salt would have additional toxicity concerns beyond 
any toxicity concerns associated with the acid due to the presence of 
mercury). However, the IRIS assessment does establish that the overall 
compound has at least the same toxicity of the associated acid. The 
toxicity concerns for PFHxA apply to all members in this category.
    a. Human health hazard assessment. Overall, the available evidence 
indicates that PFHxA likely causes hepatic, developmental, 
hematopoietic, and thyroid-related endocrine effects in humans. 
Specifically, for hepatic effects, the primary support for this hazard 
conclusion included evidence of increased relative liver weights and 
increased incidence of hepatocellular hypertrophy in adult rats. These 
hepatic findings correlated with changes in clinical chemistry (e.g., 
serum enzymes, blood proteins) and necrosis. Developmental effects were 
identified as a hazard based on evidence of decreased offspring body 
weight and increased perinatal mortality in exposed rats and mice. For 
hematopoietic effects, the primary supporting evidence included 
decreased red blood cell counts, decreased hematocrit values, and 
increased reticulocyte counts in adult rats. A 28-day study in rats 
showed a strong dose-dependent decrease in serum thyroid hormones in 
males. An overall RfD of 5 x 10<SUP>-4</SUP> mg/kg-day was selected 
based on developmental effects (decreased postnatal body weight) and is 
considered protective of the other effects (Ref. 32).
    b. Conclusion. EPA believes there is sufficient evidence to list 
the PFHxA, Salts, Acyl Halides, and Anhydride category on the TRI 
pursuant to EPCRA section 313(d)(2)(B)(ii)(IV) for serious or 
irreversible chronic effects on the liver, thyroid, hematopoietic 
system, and development.
10. Perfluorononanoic Acid (PFNA) (CASRN 375-95-1), Salts, Acyl 
Halides, and Anhydride Category
    This category would include all associated salts and acyl halides 
including: heptadecafluorononanoyl fluoride (CASRN 558-95-2), ammonium 
perfluorononanoate (CASRN 4149-60-4), potassium perfluorononanoate 
(CASRN 21049-38-7), sodium heptadecafluorononanoate (CASRN 21049-39-8), 
and heptadecafluorononanoyl chloride (CASRN 52447-23-1), and 
perfluorononanoic anhydride (CASRN 228407-54-3). PFNA has been on the 
TRI list since January 1, 2020, pursuant to NDAA section 7321(b)(1)(H). 
EPA is now proposing to list PFNA and its associated salts and acyl 
halides as a single TRI category, as the salts would be expected to 
dissociate in aqueous solutions and the acyl halides would be expected 
to be converted to PFNA in aqueous solutions. Therefore, the toxicity 
concerns for PFNA apply to all members in this category.
    a. Human Health Hazard Assessment. In April 2024, EPA finalized a 
National Primary Drinking Water Rule (NPDWR) for PFOA and PFOS, as well 
as three other PFAS (PFNA, PFHxS and HFPO-DA) and mixtures of two or 
more of four PFAS (PFNA, PFHxS, HFPO-DA and PFBS); one of the PFAS 
covered in the NPDWR is PFNA (89 CFR 32532; April 26, 2024) (Ref. 33). 
In the final NPDWR, EPA cited associations between PFNA exposure and 
adverse hepatic effects and limited evidence for decreased antibody 
response in epidemiological studies (Ref. 4). The final NPDWR also 
noted that results of a 2023 meta-analysis suggest that decreases in 
birth weight are an adverse effect of PFNA exposure in humans (Ref. 
34). In animal

[[Page 81789]]

studies, offspring of PFNA-exposed rodents had reduced bodyweights and 
survival, and delayed development (Ref. 4). ATSDR established an 
intermediate-duration oral minimal risk level (MRL) of 3 x 
10<SUP>-6</SUP> mg/kg/day for PFNA based on decreased body weight gain 
and developmental delays in mice born to mothers that were orally 
exposed to PFNA during gestation (with presumed continued indirect 
exposure of offspring via lactation) (Ref. 4). EPA concluded that 
studies on exposure to PFNA support adverse effects, including effects 
on development, reproduction, immune function, and the liver (Ref. 4, 
33).
    The draft IRIS assessment for PFNA(Ref. 35) supported the findings 
in the ATSDR toxicological profile and the NPDWR's conclusions that 
toxic endpoints were development, reproduction, and the liver, but 
stated that the evidence of immunotoxicity was only suggestive. The 
draft IRIS assessment indicated that there is robust epidemiological 
evidence that PFNA exposure is associated with deficits in birth 
weight, and that this finding is supported by coherent findings of 
postnatal growth restriction and to a lesser degree decreased birth 
length (Ref. 35). The overall lifetime oral RfD of 7 x 10<SUP>-9</SUP> 
mg/kg-day was selected based on developmental effects (decreased birth 
weight) (Ref. 35).
    b. Conclusion. EPA believes there is sufficient evidence to list 
the PFNA, Salts, Acyl Halides, and Anhydride category on the TRI 
pursuant to EPCRA section 313(d)(2)(B)(ii)(I) and (IV) for serious or 
irreversible reproductive dysfunctions and other chronic health effects 
in humans (including reproduction/development and liver effects).
11. 1H,1H, 2H, 2H-Perfluorooctane Sulfonic Acid (6:2 fluorotelomer 
sulfonic acid, 6:2 FTS) (CASRN 27619-97-2), Salts, Sulfonyl Halides, 
and Anhydride Category
    This category would include all associated salts and sulfonyl 
halides including: 1H,1H,2H,2H-perfluorooctyl iodide (CASRN 2043-57-4), 
3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctanesulphonyl chloride (CASRN 
27619-89-2), sodium 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctane-1-
sulfonate (CASRN 27619-94-9), potassium 3,3,4,4,5,5,6,6,7,7,8,8,8-
tridecafluorooctanesulphonate (CASRN 59587-38-1), 6:2 fluorotelomer 
sulphonate ammonium (CASRN 59587-39-2) and 1-octanesulfonic acid, 
3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluoro-, barium salt (2:1) (CASRN 
1807944-82-6). EPA is proposing to list 6:2 FTS and its associated 
salts and sulfonyl halides as a single TRI category, as the salts are 
expected to dissociate in aqueous solutions and the sulfonyl halides 
would be expected to be converted to 6:2 FTS in aqueous solutions. 
Therefore, the toxicity concerns for 6:2 FTS apply to all members in 
this category.
    a. Human health hazard assessment. EPA reviewed available 
literature in EPA HAWC for 6:2 FTS, as identified in Carlson et al., 
(Ref. 14) and Radke et al. (Ref. 36) (PFAS 150 (2022) project). (For 
study details, see: https://hawc.epa.gov/assessment/100500085/.) A 28-
day repeated-dose oral gavage study in male CD-1 mice by Sheng et al. 
(Ref. 37), which was evaluated as medium confidence for clinical 
chemistry and body/liver weights, found significant increases in 
absolute and relative liver weights relative to controls, with no 
effect on body weights. Serum levels of AST and albumin (ALB) were also 
significantly increased. Study results also qualitatively reported 
histopathological observations consistent with liver injury, including 
necrosis and hepatocellular hypertrophy. The effect size for increased 
liver weight is considered biologically significant (22% increase 
relative to controls).
    Other studies included in the EPA HAWC PFAS 150 (2022) project (as 
supplemental studies) for 6:2 FTS include assessments summarized by the 
European Chemicals Agency (ECHA), describing mechanistic evidence and 
genotoxicity. ECHA assessed the genotoxicity of 6:2 FTS in in vitro and 
in vivo assays. Overall, 6:2 FTS was positive for inducing structural 
chromosomal aberrations in Chinese Hamster Ovary (CHO) cells but was 
negative in all other genotoxicity assays. Other mechanistic evidence 
suggests 6:2 FTS exposure induces inflammation, including in the liver, 
and disrupts liver gene expression. Sheng et al., (Ref. 37) reported 
increased cytokines in serum and liver (TNF[alpha], Il[beta], IL-10), 
and increased expression of proteins indicative of an inflammatory 
response (IkBa, NFkB/p65, NRF-2, TRL-4, and TNFR-2) in male CD-1 mice 
after 28 days of oral exposure to 6:2 FTS at a dose of 5 mg/kg/day.
    b. Conclusion. EPA believes there is sufficient evidence to list 
the 6:2 FTS, Salts, Sulfonyl Halides, and Anhydride category on the TRI 
pursuant to EPCRA section 313(d)(2)(ii)(IV) for serious or irreversible 
chronic effects (including adverse liver and genotoxicity effects).
12. Perfluorooctanoic Acid (PFOA) (CASRN 335-67-1), Salts, Acyl 
Halides, and Anhydride Category
    This category would include all associated salts and acyl halides 
including: pentadecafluorooctanoyl chloride (CASRN 335-64-8), 
pentadecafluorooctanoyl fluoride (CASRN 335-66-0), silver 
perfluorooctanoate (CASRN 335-93-3) (currently TRI-listed as 
``silver(I) perfluorooctanoate''), sodium perfluorooctanoate (CASRN 
335-95-5), potassium perfluorooctanoate (CASRN 2395-00-8), ammonium 
perfluorooctanoate (CASRN 3825-26-1), lithium perfluorooctanoate (CASRN 
17125-58-5), cesium perfluorooctanoate (CASRN 17125-60-9), 
perfluorooctanoic anhydride (CASRN 33496-48-9), chromium 
perfluorooctanoate (CASRN 68141-02-6) (currently TRI-listed as 
chromium(III) perfluorooctanoate) and potassium 
pentadecafluorooctanoate--water (1:1:2) (CASRN 98065-31-7). In January 
2020, PFOA and three of its salts were automatically added to the TRI 
chemical list as individual chemicals pursuant to the NDAA section 
7321(b)(1)(A) and (B). EPA is now proposing to list PFOA and its 
associated salts and acyl halides as a single TRI category, as the 
salts would be expected to dissociate in aqueous solutions and the acyl 
halides would be expected to be converted to PFOA in aqueous solutions. 
Therefore, the toxicity concerns for PFOA apply to all members in this 
category.
    a. Human health hazard assessment. EPA developed a National Primary 
Drinking Water Regulation for PFOA, which was finalized on April 26, 
2024 (Ref. 33), and as part of the rulemaking, EPA published the 
``Final--Human Health Toxicity Assessment for Perfluorooctanoic Acid 
(PFOA) and Related Salts'' (Ref. 38). The Agency determined that PFOA 
is Likely to be Carcinogenic to Humans based on the 2005 Guidelines for 
Carcinogen Risk Assessment (Ref. 39) and developed a draft cancer slope 
factor (CSF) of 0.0293 (ng/kg bw-day)<SUP>-1</SUP> based on renal cell 
carcinomas in human males. The Agency also developed a draft chronic 
RfD of 3 x 10<SUP>-8</SUP> mg/kg bw-day, based on the following co-
critical effects: decreased anti-tetanus and anti-diphtheria antibody 
concentrations in children; decreased birth weight; and increased total 
serum cholesterol in adults. The Agency considers the RfDs to be 
applicable to both short-term and chronic risk assessment scenarios 
because two of the co-critical effects identified for PFOA are 
developmental effects that can potentially result from

[[Page 81790]]

short-term PFOA exposure during a critical period of development. 
Therefore, short-term PFOA exposure during a critical period of 
development may lead to adverse health effects across life stages (Ref. 
38).
    b. Conclusion. EPA believes there is sufficient evidence to list 
the PFOA, Salts, Acyl Halides, and Anhydride category on the TRI 
pursuant to EPCRA section 313(d)(2)(B)(i) and (ii)(IV) for serious or 
irreversible chronic human health effects (including cancer and 
developmental effects).
13. Perfluorooctanesulfonic Acid (PFOS) (CASRN 1763-23-1), Salts, 
Sulfonyl Halides, and Anhydride Category
    This category would include all associated salts and sulfonyl 
halides including: perfluorooctylsulfonyl fluoride (CASRN 307-35-7), 
perfluorooctanesulfonic anhydride (CASRN 423-92-7), potassium 
perfluorooctanesulfonate (CASRN 2795-39-3), sodium 
perfluorooctanesulfonate (CASRN 4021-47-0), ammonium 
perfluorooctanesulfonate (CASRN 29081-56-9) (currently TRI-listed as 
``1-Octanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
heptadecafluoro-, ammonium salt''), lithium perfluorooctanesulfonate 
(CASRN 29457-72-5) (currently TRI-listed as ``lithium 
(perfluorooctane)sulfonate''), tetraethylammonium 
perfluorooctanesulfonate (CASRN 56773-42-3) (currently TRI-listed as 
``Ethanaminium, N,N,N-triethyl-, salt with 
1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-1-octanesulfonic acid 
(1:1)''), 1-octanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
heptadecafluoro-, compd. With 2,2'-iminobis[ethanol] (1:1) (CASRN 
70225-14-8), magnesium bis(heptadecafluorooctanesulfonate) (CASRN 
91036-71-4), and tetrabutylammonium perfluorooctanesulfonate (CASRN 
111873-33-7). In January 2020, PFOS and five of its salts were 
automatically added to the TRI chemical list as individual chemicals 
pursuant to the NDAA section 7321(b)(1)(C) and (D). EPA is now 
proposing to list PFOS and its associated salts and sulfonyl halides as 
a single TRI category, as the salts would be expected to dissociate in 
aqueous solutions and the sulfonyl halides would be expected to be 
converted to PFOS in aqueous solutions. Therefore, the toxicity 
concerns for PFOS apply to all members in this category.
    a. Human health hazard assessment. The Agency determined that PFOS 
is Likely to be Carcinogenic to Humans based on the 2005 Guidelines for 
Carcinogen Risk Assessment (Ref. 39) and developed a draft CSF of 39.5 
(mg/kg bw-day)<SUP>-1</SUP> based on hepatocellular adenomas and 
carcinomas in female rats (Ref. 40). The Agency also developed a 
chronic RfD of 1.0 x 10<SUP>-7</SUP> mg/kg bw-day, based on co-critical 
effects of decreased birthweight in infants and increased serum total 
cholesterol in adults. The Agency considers the RfDs to be applicable 
to both short-term and chronic risk assessment scenarios because one of 
the co-critical effects identified for PFOS is a developmental effect 
that can potentially result from short-term PFOS exposure during a 
critical period of development. Therefore, short-term PFOS exposure 
during a critical period of development may lead to adverse health 
effects across life stages (Ref. 40).
    b. Conclusion. EPA believes there is sufficient evidence to list 
the PFOS, Salts, Sulfonyl Halides, and Anhydride category on the TRI 
pursuant to EPCRA section 313(d)(2)(B)(i) and (ii)(IV) for serious or 
irreversible chronic human health effects (including cancer and 
developmental effects).
14. Perfluoropropanoic Acid (PFPrA) (CASRN 422-64-0), Salts, Acyl 
Halides, and Anhydride Category
    This category would include all associated salts, acyl halides, and 
the anhydride including: pentafluoropropanoic anhydride (CASRN 356-42-
3), potassium perfluoropropanoate (CASRN 378-76-7), sodium 
perfluoropropanoate (CASRN 378-77-8), perfluoropropanoyl chloride (422-
59-3), and perfluoropropanoyl fluoride (CASRN 422-61-7). In July 2023, 
EPA finalized a human health toxicity value for PFPrA (Ref. 41). 
Accordingly, PFPrA is automatically added to the TRI chemical list as 
of January 1, 2024, pursuant to the NDAA section 7321(c)(1)(A)(i). EPA 
is now proposing to list PFPrA and its associated salts and acyl 
halides and anhydride as a single TRI category, as the salts (including 
non-metal and alkali metal salts) would be expected to dissociate in 
aqueous solutions and the acyl halides and anhydride would be expected 
to be converted to PFPrA in aqueous solutions. Therefore, the toxicity 
concerns for PFPrA apply to all members in this category.
    a. Human health hazard assessment. In a 28-day oral study in rats, 
increased relative liver weight was observed in males at >=20 mg/kg-d, 
accompanied by hepatocyte lesions (primarily hypertrophy with some 
evidence of slight focal necrosis) and serum markers of hepatocellular/
hepatobiliary injury (i.e., increased ALT, ALP) at >=80 mg/kg-d. 
Despite the lack of additional oral repeat-dose studies examining liver 
effects of PFPrA by which to evaluate similarity of results, this 
profile of PFPrA-induced liver effects is consistent with the liver 
toxicity observed in experimental rodents following oral exposure to 
perfluorobutanoic acid, a closely related linear short-chain (4-carbon) 
perfluorocarboxylic acid (Ref. 41).
    The PFPrA toxicity assessment derived a chronic RfD of 1 x 
10<SUP>-4</SUP> mg/kg-day based on liver effects (Ref. 41).
    b. Conclusion. EPA believes there is sufficient evidence to list 
the PFPrA, Salts, Acyl halides, and Anhydride category on the TRI 
pursuant to EPCRA section 313(d)(2)(B)(ii)(IV) for serious or 
irreversible liver toxicity.
15. Perfluoroundecanoic Acid (PFUnA) (CASRN 2058-94-8), Salts, Acyl 
Halides, and Anhydride Category
    This category would include all associated salts and acyl halides 
including: ammonium perfluoroundecanoate (CASRN 4234-23-5), potassium 
perfluoroundecanoate (CASRN 30377-53-8), sodium perfluoroundecanoate 
(CASRN 60871-96-7), calcium perfluoroundecanoate (CASRN 97163-17-2), 
and perfluoroundecanoic anhydride (CASRN 942199-03-3). EPA found 
evidence of both serious or irreversible human health effects and 
environmental effects due to PFUnA and its salts. EPA is proposing to 
list PFUnA and its associated salts and acyl halides as a single TRI 
category, as the salts would be expected to dissociate in aqueous 
solutions and the acyl halides would be expected to be converted to 
PFUnA in aqueous solutions. Therefore, the toxicity concerns for PFUnA 
apply to all members in this category.
    a. Human health hazard assessment. In a combined repeat-dose oral 
toxicity study with a reproductive/developmental screening test, rats 
were exposed to PFUnA at daily doses of 0.1, 0.3, or 1.0 mg/kg-day; the 
study was conducted consistent with OECD 422 protocol. Following PFUnA 
exposure for 41-46 days, indicators of toxicity were observed in the 
liver, kidney, and spleen of adult male and female rats. Statistically 
significant increases in absolute and relative liver weights and 
histopathological evidence of altered tissue architecture (e.g., 
hepatocellular hypertrophy) were observed in male (>=0.3 mg/kg-day) and 
female (1.0 mg/kg-day) rats. Serum enzymes indicative of hepatocellular 
(e.g., ALT) and biliary epithelial (e.g., ALP) injury were also

[[Page 81791]]

observed immediately after cessation of exposure but only in males at 
the high dose of 1.0 mg/kg-day. A statistically significant increase in 
a blood biomarker indicative of kidney injury (i.e., BUN) was also 
observed in male and female rats at 1.0 mg/kg-day. The spleen was also 
adversely affected by oral PFUnA exposure, as statistically significant 
decreased absolute and relative organ weights were observed in male and 
female rats at 1.0 mg/kg-day. Developmental effects entailed 
statistically significant decreases in the body weight of male and 
female offspring, on PNDs 0 and 4, in litters of the high dose rats. 
Based on systemic organ toxicities in adults and body weight decrements 
in offspring, a study NOAEL of 0.3 mg/kg-day and LOAEL of 1.0 mg/kg-day 
were identified (Ref. 42).
    The pattern of liver effects seen for PFUnA in the OECD 422 study 
are consistent with those seen for other, more well-characterized PFAS. 
Specifically, the RfDs for GenX and PFBA are based on the same liver 
foci (e.g., increased organ weights; liver hypertrophy and associated 
pathological lesions), as described for PFUnA exposure by Takahashi et 
al. (2014) (Ref. 43).
    b. Conclusion. EPA believes there is sufficient evidence to list 
the PFDoA, Salts, Acyl Halides, and Anhydride category on the TRI 
pursuant to EPCRA section 313(d)(2)(B)(ii)(IV), for serious or 
irreversible liver, kidney, spleen, and developmental outcomes.

C. What are the proposed individual chemicals?

    The following chemicals are being proposed as individually listed 
additions to the TRI list (i.e., EPA did not identify known, associated 
salts for purposes of this proposed listing) and reason for inclusion:
    <bullet> Broflanilide (CASRN 1207727-04-5), which is based on EPCRA 
313(d)(2)(B) (Chronic Human Health) and 313(d)(2)(C) (Effect on the 
Environment);
    <bullet> 1-Butanesulfonamide, 1,1,2,2,3,3,4,4,4-nonafluoro-N-
methyl- (MeFBSA) (CASRN 68298-12-4), which is based on EPCRA 
313(d)(2)(B) (Chronic Human Health);
    <bullet> 1-Butanesulfonamide, 1,1,2,2,3,3,4,4,4-nonafluoro-N-(2-
hydroxyethyl)-N-methyl- (MeFBSE) (CASRN 34454-97-2), which is based on 
EPCRA 313(d)(2)(B) (Chronic Human Health);
    <bullet> Cyclopentene, 1,3,3,4,4,5,5-heptafluoro- (HFCPE) (CASRN 
1892-03-1), which is based on EPCRA 313(d)(2)(C) (Effect on the 
Environment);
    <bullet> Ethanesulfonamide, 1,1,2,2,2-pentafluoro-N-
[(pentafluoroethyl)sulfonyl]-, lithium salt (CASRN 132843-44-8), which 
is based on EPCRA 313(d)(2)(B) (Chronic Human Health);
    <bullet> 6:2 Fluorotelomer alcohol (6:2 FTOH) (CASRN 647-42-7), 
which is based on EPCRA 313(d)(2)(B) (Chronic Human Health);
    <bullet> Fulvestrant (CASRN 129453-61-8), which is based on EPCRA 
313(d)(2)(C) (Effect on the Environment);
    <bullet> Hexaflumuron (CASRN 86479-06-3), which is based on EPCRA 
313(d)(2)(C) (Effect on the Environment);
    <bullet> Pentane, 1,1,1,2,2,3,4,5,5,5-decafluoro-3-methoxy-4-
(trifluoromethyl)- (CASRN 132182-92-4), which is based on EPCRA 
313(d)(2)(B) (Chronic Human Health);
    <bullet> Perfluorotridecanoic acid (PFTrDA) (CASRN 72629-94-8), 
which is based on EPCRA 313(d)(2)(C) (Effect on the Environment);
    <bullet> Perfluoro(2-ethoxy-2-fluoroethoxy)acetic acid ammonium 
salt (EEA-NH4) (CASRN 908020-52-0), which is based on EPCRA 
313(d)(2)(B) (Chronic Human Health);
    <bullet> 2-Propenoic acid, 2-
[methyl[(nonafluorobutyl)sulfonyl]amino]ethyl ester (MeFBSEA) (CASRN 
67584-55-8). Which is based on EPCRA 313(d)(2)(B) (Chronic Human 
Health);
    <bullet> Pyrifluquinazon (CASRN 337458-27-2), which is based on 
EPCRA 313(d)(2)(B) (Chronic Human Health);
    <bullet> Tetraconazole (CASRN 112281-77-3), which is based on EPCRA 
313(d)(2)(B) (Chronic Human Health) and 313(d)(2)(C) (Effect on the 
Environment);
    <bullet> Triethoxy(3,3,4,4,5,5,6,6,7,7,8,8,8-tri-deca-
fluorooctyl)silane (CASRN 51851-37-7), which is based on EPCRA 
313(d)(2)(B) (Chronic Human Health); and
    <bullet> Trifluoro(trifluoromethyl) oxirane (HFPO) (CASRN 428-59-
1), which is based on EPCRA 313(d)(2)(B) (Chronic Human Health).
    The Agency has provided important endpoints in the following 
summary. For the full toxicological profile, please refer to the 
respective references.
1. Broflanilide (CASRN 1207727-04-5)
    EPA has previously reviewed broflanilide as part of the pesticide 
registration process under the Federal Insecticide, Fungicide and 
Rodenticide Act (FIFRA).
    a. Human health hazard assessment. The target organs of 
broflanilide toxicity are the adrenal glands (rats, mice, and dogs) and 
ovaries (rats and mice). Adrenal effects include increased adrenal 
weights, increased incidence of adrenal cortex vacuolation and adrenal 
cortex hypertrophy in both sexes. Ovarian effects include increased 
incidence of ovarian interstitial gland vacuolation (Ref. 44).
    For the Chronic Dietary Endpoint for the General Populations, A 2-
generation reproductive toxicity study (MRID 50211379) was selected 
with a NOAEL of 3 mg/kg/day and a LOAEL of 8 mg/kg/day based on 
increased adrenal weights with corroborative histopathological findings 
(increased vacuolation and diffuse hypertrophy in the adrenal gland 
cortex) in both sexes and both generations. Although an apparent lower 
NOAEL (2 mg/kg/day) was identified for females in the chronic rat 
study, it was a reflection of dose selection. The selected POD of 3 mg/
kg/day is still protective for the effects noted in the chronic rat 
study at the LOAEL of 7.1 mg/kg/day. An uncertainty factor of 100X (10X 
for interspecies extrapolation, 10X for intraspecies variation, and 1X 
for FQPA SF) is applied. The chronic reference dose (cRfD) and chronic 
population adjusted dose (cPAD) is 0.03 mg/kg/day (Ref. 44).
    The Cancer Assessment Review Committee (CARC) classified 
broflanilide as ``Likely to be Carcinogenic to Humans'' based on Leydig 
cell tumors and all ovarian tumors combined (granulosa cell benign and 
malignant, luteomas, thecomas and sex cord stromal tumors). The unit 
risk, Q<INF>1</INF>* (mg/kg/day)<SUP>-1</SUP>, of broflanilide based 
upon male rat testicular Leydig cell tumor rates is 2.48 x 
10<SUP>-3</SUP> in human equivalents (Ref. 44).
    b. Ecological hazard assessment. Although there were no effects 
seen at the highest dose tested in acute daphnia (Daphnia magna) and 
eastern oyster (Crassostrea virginica) tests, an acute study with mysid 
resulted in a LC<INF>50</INF> of 0.0215 [mu]g a.i./L, with a steep dose 
response (35%, 95% and 100% mortality at 0.0202, 0.0284, and 0.0428 
[mu]g a.i./L respectively). Based on the mysid data, broflanilide is 
classified as very highly toxic to aquatic estuarine marine 
invertebrates. In chronic studies, the Daphnia NOAEC of 5.93 [mu]g 
a.i./L was based upon 6-8% reductions in length, total offspring, birth 
rate, and time to first brood at 11.6 [mu]g a.i./L. The mysid study did 
not establish a definitive NOAEC endpoint because at the lowest test 
concentration, 0.0018 [mu]g a.i./L, there was 17% reduced survival for 
F1 and 22% reduced offspring per female (Ref. 45).
    Studies with freshwater species Chironomus dilutus and Hyalella 
azteca, and the estuarine/marine species Leptocheirus plumulosus 
resulted in

[[Page 81792]]

LC<INF>50</INF>s of 9.99, 13.5, and 14 [mu]g ai/kg dry sediment. In a 
28-day spiked sediment test with Leptocheirus plumulosus, the NOAEC was 
determined to be 3.8 [mu]g ai/kg dry sediment based on 12% reduced 
survival at the LOAEC. Broflanilide is highly toxic to honeybees (Apis 
mellifera) and bumble bees (Bombus terrestris) on both an acute contact 
and oral exposure basis. In an acute (single dose) contact and acute 
oral combined toxicity study with adult honeybees (Apis mellifera), the 
48-hr contact LD<INF>50</INF> = 0.0088 [micro]g a.i./bee and acute oral 
LD<INF>50</INF> = 0.0149 [micro]g a.i./bee (Ref. 45).
    Broflanilide is persistent in terrestrial and aquatic environments. 
Broflanilide is stable to hydrolysis and soil photolysis and under 
anaerobic and aerobic conditions, and it persists in soil and water, 
with half-lives ranging from months to years (Ref. 45).
    c. Conclusion. EPA believes there is sufficient evidence to list 
broflanilide pursuant to EPCRA section 313(d)(2)(B)(i) for cancer and 
(ii)(IV) for serious or irreversible chronic human health effects, as 
well as (d)(2)(C) for toxicity and persistence.
2. 1-Butanesulfonamide, 1,1,2,2,3,3,4,4,4-nonafluoro-N-(2-
hydroxyethyl)-N-methyl- (MeFBSE) (CASRN 34454-97-2)
    a. Human health hazard assessment. 1-Butanesulfonamide, 
1,1,2,2,3,3,4,4,4-nonafluoro-N-(2-hydroxyethyl)-N-methyl-is also 
referred to by the synonym 1,1,2,2,3,3,4,4,4-nonafluoro-N-(2-
hydroxyethyl)-N-methyl-1-butanesulfonamide (MeFBSE). Hepatic effects 
observed after subchronic oral exposure in adult rats included elevated 
absolute and relative liver weight and hepatocellular hypertrophy in 
both sexes, and hepatocyte necrosis in male rats, at 250 mg/kg-day. 
Compared with the control group, at 250 mg/kg-day, ALT levels of 
treated female rats were increased 1.6-fold, and in male rats were 
increased 1.3-fold. The dose-dependent increases in organ weight, 
incidence of histopathological alterations (e.g., cellular hypertrophy 
and necrosis), and although not statistically significant, serum ALT, 
suggests liver injury following repeated exposure to MeFBSE. It should 
be noted that while these results suggest a dose-dependent progression 
of liver injury, the temporality of exposure duration is typically 
associated with increased incidence and/or severity of liver injury 
over time; however, longer duration studies to inform the influence of 
prolonged exposure on this liver injury profile are not available for 
MeFBSE (Ref. 46).
    Renal changes were limited to increases in absolute and relative 
kidney weights in males at 50 and 250 mg/kg-day. (There was only 
increased relative kidney weight in high-dose females.) No 
histopathology or clinical chemistry parameters indicative of kidney 
injury were reported. The changes observed in the kidney were primarily 
observed in male rats and were limited to organ weight information; as 
such, in the absence of confirmatory histopathological and/or clinical 
chemistry evidence of renal injury, it is unclear if the observations 
in kidney weight are adverse (Ref. 46).
    Oral MeFBSE exposure also induced effects in a reproduction/
developmental screening test in rats (performed in accordance with the 
OECD Test No: 422). MeFBSE caused significant decreases in livebirth 
and viability indices for pups, and the average number of pups/litter 
surviving to PND 5 were decreased at 250 mg/kg-day maternal dose (Ref. 
46).
    b. Conclusion. EPA believes there is sufficient evidence to list 
MeFBSE on the TRI pursuant to EPCRA section 313(d)(2)(B)(ii)(IV) based 
on serious or irreversible liver toxicity and developmental toxicity 
for this chemical.
3. 1-Butanesulfonamide, 1,1,2,2,3,3,4,4,4-nonafluoro-N-methyl- (MeFBSA) 
(CASRN 68298-12-4)
    a. Human health hazard assessment. 1-Butanesulfonamide, 
1,1,2,2,3,3,4,4,4-nonafluoro-N-methyl- is also referred to by the 
synonym N-(methyl)nonafluorobutanesulfonamide (MeFBSA). The single 
repeated-dose oral toxicity study with reproductive/developmental 
screen in rats showed decreased conception rate in female rats with 
corresponding decreases in fertility and gestation indices, increased 
postnatal loss and decreased viability index of pups, and decreases in 
pup weight and increases in the incidence of small pups during 
lactation. Given that there is a dose-response relationship with 
statistically significant changes compared to control rats for the 
viability index (Ref. 47), the NOAEL is n.d. and the LOAEL is 50 mg/kg-
day for reproductive/developmental effects. However, there is 
uncertainty in the assignment of a LOAEL of 50 mg/kg-day for post-natal 
loss and decreased viability since single litter losses contribute to 
the postnatal loss values. In summary, the available literature 
provides evidence that MeFBSA can be reasonably anticipated to cause 
serious or irreversible reproductive and developmental toxicity in 
humans (Ref. 47).
    b. Conclusion. EPA believes there is sufficient evidence to list 
MeFBSA on the TRI pursuant to EPCRA section 313(d)(2)(B) for serious or 
irreversible reproductive and developmental toxicity.
4. Cyclopentene, 1,3,3,4,4,5,5-heptafluoro (HFCPE; CASRN 1892-03-1)
    a. Ecological hazard assessment. The experimental data for HFCPE 
from aquatic toxicity studies includes acute toxicity endpoint values 
as low as of 0.19 mg/L in freshwater fish (96-hour LC<INF>50</INF> in 
Oryzias latipes), 0.26 mg/L in aquatic invertebrates (48-hour 
EC<INF>50</INF> for immobilization of Daphnia magna), and 0.9 mg/L in 
algae (72-hour EC<INF>50</INF> for decreased growth rate in 
Pseudokirchneriella subcapitata) (Ref. 48).
    b. Conclusion. EPA believes there is sufficient evidence to list 
HFCPE on the TRI pursuant to EPCRA section 313(d)(2)(C)(i) for 
environmental toxicity.
5. Ethanesulfonamide, 1,1,2,2,2-pentafluoro-N-
[(pentafluoroethyl)sulfonyl]-, Lithium Salt (CASRN 132843-44-8)
    a. Human health hazard assessment. The available toxicity data for 
ethanesulfonamide, 1,1,2,2,2-pentafluoro-N-
[(pentafluoroethyl)sulfonyl]-, lithium salt (CASRN 132843-44-8) (also 
referred to by the synonym lithium 
bis[(pentafluoroethyl)sulfonyl]azanide), obtained from an unpublished 
28-day oral rat study, are limited but provide evidence that the liver 
is a sensitive target organ. The mid dose of 2 mg/kg-day was identified 
as a LOAEL based on hepatic effects, including increases in liver 
weight, serum chemistry changes associated with hepatotoxicity [e.g., 
alanine aminotransferase (ALT) and alkaline phosphatase (ALP)], 
increased incidence and severity of hepatocellular hypertrophy in both 
sexes, and increased incidence of focal necrosis of hepatocytes in male 
rats (Ref. 49).
    b. Conclusion. EPA believes there is sufficient evidence to list 
ethanesulfonamide, 1,1,2,2,2-pentafluoro-N-
[(pentafluoroethyl)sulfonyl]-, lithium salt on the TRI pursuant to 
EPCRA section 313(d)(2)(B)(ii)(IV) for serious or irreversible chronic 
human health effects (hepatotoxicity).
6. 6:2 Fluorotelomer Alcohol (6:2 FTOH) (CASRN 647-42-7)
    a. Human health hazard assessment. Histopathological changes in the 
liver and kidney were reported in two

[[Page 81793]]

subchronic rat and mouse feeding studies following exposure to 6:2 FTOH 
in the diet. The liver changes included elevated organ weight and/or 
hepatocellular hypertrophy (and in some studies, other hepatic lesions 
such as oval cell hyperplasia, cystic degeneration, and single cell 
necrosis). These alterations were observed in rats at >=25 mg/kg-day 
and in mice at >=5 mg/kg-day. In addition, the elevated clinical 
chemistry parameters indicative of hepatocellular injury are greater in 
females than males at the highest test concentrations (100 mg/kg/day 
and 250 mg/kg/day, for mice and rats, respectively) of 6:2 FTOH. In 
mice, hepatic clinical chemistry values, including serum ALT and AST 
were significantly increased at 100 mg/kg-day 6:2 FTOH in F0 males (2.5 
to 5-fold) and F0 females (>5-fold). Significant increments (compared 
with the control groups) were also observed in the 6:2 FTOH treated rat 
serum ALT (+57% increase in male rats at 125 mg/kg-day) and GGT (+188% 
increase in female rats and +57% increase in male rats at 125 mg/kg-
day) levels. The additional target organ of 6:2 FTOH toxicity was the 
kidney in both rats and mice, with effects observed at >=25 mg/kg bw-
day in rats and 100 mg/kg bw-day in mice. At high doses of 6:2 FTOH, 
effects on the kidney were severe in rats, and identified as a cause of 
mortality in multiple studies (Ref. 50).
    b. Conclusion. EPA believes there is sufficient evidence to list 
6:2 FTOH on the TRI pursuant to EPCRA section 313(d)(2)(B)(ii)(IV) for 
serious or irreversible chronic health effects (hepatotoxicity and 
nephrotoxicity).
7. Fulvestrant (CASRN 129453-61-8)
    Fulvestrant is also referred to by the synonym (7alpha,17beta)-7-
[9-[(4,4,5,5,5-pentafluoropentyl)sulfinyl]nonyl]estra-1,3,5(10)-triene-
3,17-diol.
    a. Ecological hazard assessment. As described in Unit II.B., EPA is 
exploring additional means for identifying chemicals as candidates for 
TRI listing. ECOTOX data describes environmental effects for 
fulvestrant (CASRN 129453-61-8) (Ref. 51). In Daphnia magna exposed to 
fulvestrant, mortality was observed at 0.129 mg/L (mean 
LC<INF>50</INF>) after a 96-h exposure, and statistically significant 
reproductive effects of reduced brood size were observed at a lowest 
effect concentration of 0.001 mg/L in chronic tests (Ref. 52). 
Statistically significant abnormal development (defined as missing 
anatomical features, deformities, and incomplete gut development) was 
observed in sea urchin larvae, Strongylocentrotus purpuratus, exposed 
to fulvestrant both alone (EC<INF>50</INF> value of 0.000058 mg/L), as 
well as in co-incubation experiments with endocrine disrupting 
compounds (EDCs) resulting in increased developmental abnormalities by 
10-20% (lowest effect concentration of 0.00003 mg/L) (Ref. 53). In 
mature male Atlantic croakers (Micropogonias undulatus), exposure to 
fulvestrant was observed to inhibit production of a predominant 
androgen, 11-ketotestosterone in in vitro cell cultures by functioning 
as an estrogen agonist when binding to the testicular estrogen membrane 
receptor at 0.055 mg/L (mean EC<INF>50</INF>) (Ref. 54).
    b. Conclusion. EPA believes there is sufficient evidence to list 
fulvestrant on the TRI pursuant to EPCRA section 313(d)(2)(C)(i) for 
environmental toxicity.
8. Hexaflumuron (CASRN 86479-06-3)
    a. Ecological hazard assessment. Hexaflumuron is very highly toxic 
to aquatic invertebrates, but not terrestrial invertebrates, birds, and 
mammals, on an acute exposure basis. In particular, hexaflumuron is 
very highly toxic to water flea (Daphnia magna), with a 48 hour 
LC<INF>50</INF> of 0.111 [micro]g ai./L (Ref. 55).
    On a chronic exposure basis, hexaflumuron resulted in reduced 
survival in birds (mallard duck and bobwhite quail) and reduced growth 
(pup body weights) in rats. In a 2-generation reproduction study with 
the rat (Rattus norvegicus), no adverse, treatment-related effects were 
observed on adult (parental) mortality, clinical signs, body weight, 
body weight gain, food consumption, hematology, organ weights, or gross 
or histological pathology throughout the study in either generation. 
However, the LOAEL for offspring toxicity was observed based on 
decreased pup body weights at 125 mg/kg bw/day dose level; the NOAEL 
was 25 mg/kg bw/day. In an avian reproduction toxicity study with 
mallard ducks (Anas platyrhynchos), the NOAEC was 29.4 mg ai./kg-diet 
(mean-measured) and the LOAEC was 96.5 mg ai./kg-diet (mean-measured) 
based on reduced survival (i.e., reduced numbers of viable embryos and 
hatchling survival) and reduced growth (i.e., hatchling body weights) 
(Ref. 55).
    b. Conclusion. EPA believes there is sufficient evidence to list 
hexaflumuron on the TRI pursuant to EPCRA section 313(d)(2)(C)(i) for 
environmental toxicity.
9. Pentane, 1,1,1,2,2,3,4,5,5,5-decafluoro-3-methoxy-4-
(trifluoromethyl)- (CASRN 132182-92-4)
    a. Human health hazard assessment. The repeated exposure hazard 
studies for pentane, 1,1,1,2,2,3,4,5,5,5-decafluoro-3-methoxy-4-
(trifluoromethyl)- (CASRN 132182-92-4), referred to by the synonym 3-
methoxyperfluoro(2-methylpentane), are limited to one 28-day oral rat 
study and a single generation reproductive/developmental study in rats 
via the inhalation route. Following oral exposure, the liver appears to 
be the most sensitive target organ. Gross enlargement and increased 
absolute and relative liver weights were statistically significantly 
increased in male rats at >=150 mg/kg-day, compared to control; 
increased liver weights in females were also observed but only at the 
high dose (1,000 mg/kg-day). Increased liver weight was accompanied by 
histopathological evidence of structural alteration (e.g., 
centrilobular hepatocellular hypertrophy) in male rats at >=150 mg/kg-
day. Focal hepatocellular necrosis was also observed but only at the 
high dose (1,000 mg/kg-day). Based on findings of liver alterations in 
male rats, a LOAEL of 150 mg/kg-day and corresponding NOAEL of 25 mg/
kg-day, are identified for oral 3-methoxyperfluoro(2-methylpentane) 
exposure (Ref. 56).
    Increased liver weights were also noted at >=72,250 mg/m\3\ in F0 
male rats of a single generation reproductive/developmental inhalation 
study; however, due to poor results reporting in the source ECHA study 
summary, incidence and/or magnitude of this effect was not discernable. 
Diffuse hepatocellular hypertrophy was also reported in the livers of 
these same male rats but again, incidence and magnitude of effect were 
not reported. Importantly, no evidence of statistically significant 
reproductive or developmental toxicity was reported in the F0 or F1 
rats up to the highest inhalation concentration tested (281,700 mg/
m\3\). Due to the lack of quantitative data provided in the source ECHA 
study summary, no LOAEC or NOAEC values were identified for the 
inhalation route of exposure (Ref. 56).
    b. Conclusion. EPA believes there is sufficient evidence to list 
pentane, 1,1,1,2,2,3,4,5,5,5-decafluoro-3-methoxy-4-(trifluoromethyl)- 
on the TRI pursuant to EPCRA section 313(d)(2)(B)(ii)(IV) for serious 
or irreversible chronic health effects (hepatotoxicity).

[[Page 81794]]

10. Perfluorotridecanoic Acid (PFTrDA) (CASRN 72629-94-8)
    a. Ecological hazard assessment. The available aquatic toxicity 
data for perfluorotridecanoic acid (PFTrDA) (CASRN 72629-94-8) suggest 
high concern for hazard upon acute exposure of aquatic organisms to 
this chemical. Based on a 120-day fish study, a NOEC of 0.01 mg/L and 
LOEC of 0.1 mg/L (MATC = 0.03 mg/L) were identified in zebrafish for 
significantly (p<0.05) reduced survival into adulthood. In addition, 
based on a 48-hour EC<INF>50</INF> of 8.2 mg/L for immobility in D. 
magna, PFTrDA can cause adverse aquatic effects. The MATC of 0.03 mg/L 
and EC<INF>50</INF> of 8.2 mg/L were obtained based on nominal 
concentrations in a study that did not use solvent, and a MATC of 0.03 
mg/L indicates a high concern for hazard to zebrafish upon chronic 
exposure to PFTrDA. It is likely that actual exposure levels were lower 
than nominal, and that the resulting MATC is lower as well (Ref. 57).
    There is substantive evidence that PFTrDA has the potential to 
bioaccumulate in organisms. Laboratory and field-derived BCF and BAF 
values, respectively, suggest PFTrDA has a high potential to 
bioaccumulate in aquatic species (e.g., BCF = 10,233-45,709 L/kg in 
zebrafish; root concentration factor (RCF) = 1,430-2,590 in aquatic 
plants; BAF = 19,953-31,623 L/kg in black-spotted frogs). Field studies 
also show that PFTrDA can biomagnify through the food chain (trophic 
magnification factor (TMF) = 3.54-4.78 at various sites in China and 
0.9-14.9 at sites in France). However, there is no measured 
environmental half-life data for PFTrDA and the derived data via model 
predictions are unreliable for the chemical (Ref. 57).
    b. Conclusion. The Agency believes there is sufficient data to list 
PFTrDA on the TRI pursuant to EPCRA section 313(d)(2)(C)(iii) for 
environmental toxicity and bioaccumulation.
11. Perfluoro(2-ethoxy-2-fluoroethoxy)acetic Acid Ammonium Salt (EEA-
NH4) (CASRN 908020-52-0)
    a. Human health hazard assessment. Perfluoro(2-ethoxy-2-
fluoroethoxy)acetic acid ammonium salt is also referred to by the 
synonym perfluoro[(2-pentafluoroethoxy ethoxy)acetic acid] ammonium 
salt (EEA-NH4).
    An article by Rice et al. (Ref. 58) summarized the findings of two 
unpublished studies conducted by Asahi Glass. These studies were 
reported to follow OECD 407 and OECD 421 protocols designed to evaluate 
potential adverse health effects associated with repeated-dose (28-
days) or reproduction and development in rats, respectively. After 28-
days of oral EEA-NH4 exposure, increased liver weights, hepatocellular 
hypertrophy, and increased kidney weight parameters were noted in male 
rats. For females, hepatocellular necrosis and renal tubule hyperplasia 
were observed. In the reproductive/developmental screening study, 
decreased body weight gains in parents and decreased body weight in 
pups, as well as decreased viability indices in pups were observed 
(Ref. 59).
    In the 28-day (OECD 407) study, a LOAEL of 5 mg/kg/day was observed 
due to renal tubule basophilia in females. In males, increased liver 
and kidney weights were observed at 25 mg/kg/day. The study also 
observed other liver effects in male rodents at 100 mg/kg/day, 
including increased serum albumin to globulin ratio, increased alanine 
aminotransferase, decreased serum cholesterol, and hepatocellular 
hypertrophy. Decreased bilirubin and focal hepatocellular necrosis were 
noted in females at 100 mg/kg/day. Both sexes saw enlarged/squamous 
hyperplasia of the limiting ridge of the stomach at 100 mg/kg/day (Ref. 
59).
    In the OECD 421 study, the LOAEL was determined to be 30 mg/kg/day 
based on decreased body weight at PND 0 and 4 for both sexes of the F1 
generation. At PND 6, decreased body weight was observed in male pups 
only at 90 mg/kg/day. Also, at 90 mg/kg/day, decreased birth index, 
increased total dead pups, and decreased total live pups/litter were 
observed. Adverse maternal reproductive effects included decreased body 
weight gain and feed consumption on Lactation Day (LD) 1-6 at 90 mg/kg/
day (although mortality was also observed at 90 mg/kg/day) (Ref. 59).
    b. Conclusion. EPA believes there is sufficient evidence to list 
EEA-NH4 on the TRI pursuant to EPCRA section 313(d)(2)(B)(ii)(I) for 
serious or irreversible reproductive dysfunctions and (IV) other 
chronic health effects.
12. 2-Propenoic Acid, 2-[methyl[(nonafluorobutyl)sulfonyl]Amino]ethyl 
Ester (MeFBSEA) (CASRN 67584-55-8)
    a. Human health hazard assessment. Data on MeFBSEA (referred to by 
the synonym 2-[methyl[(nonafluorobutyl)sulfonyl]amino]ethyl 2-
propenoate (MeFBSEA)) toxicity are limited to two unpublished oral 
toxicity studies in rats: a single 13-week oral repeat-dose study and a 
prenatal developmental toxicity study. Based on the available data 
showing organ weight, histopathological, and supporting serum chemistry 
changes, the liver and kidneys appear to be the most sensitive targets 
of toxicity. Elevated liver weights and histopathological changes were 
observed with increasing severity in male rats at >=100 mg/kg-day and 
in female rats at >=300 mg/kg-day. Measures of altered hepatic clinical 
chemistry were observed in both sexes at >=300 mg/kg-day. At the high 
dose of 703 mg/kg-day, several animals died early, which the study 
authors attributed primarily to severe liver necrosis. Kidney weights 
were increased in both sexes at >=100 mg/kg-day, and vacuolar 
degeneration and necrosis in the kidney were identified as contributing 
to early death in some rats. Effects of MeFBSEA in other tissues 
(urinary bladder, thyroid, adrenal gland) were mild and occurred 
primarily at high doses associated with overt clinical signs of 
toxicity and early mortality. In the developing fetus, decreased fetal 
body weights and increased skeletal variations were seen at doses >=300 
mg/kg-day in association with decreased maternal body weight (Ref. 60).
    An additional potential target of toxicity is the urinary bladder 
in rats. Male rats dosed with 300 mg/kg-day demonstrated statistically 
significant reductions in mean body weights on Days 57 through 71 (-8 
to -9%) and on Day 91 (-8%) (Ref. 60).
    The liver effects (e.g., hepatocellular hypertrophy, and gross 
enlargement of the liver) were observed in both male and female rats at 
100 and 300 mg/kg/day, respectively (LOAEL = 100 mg/kg/day). 
Statistically significant increases in serum alanine aminotransferase 
(ALT) levels (+47%, 1.5-fold increment in comparison with the 
respective control value) in female and male rat (+73%, 1.6-fold 
increment in comparison with the respective control value), and 
statistically significant elevation of serum ALP level (+48%, 1.5-fold) 
in male rat were observed at 300 mg/kg/day. Additionally, coagulative 
necrosis in male rat liver and centrilobular necrosis in female rat 
liver were observed at 300 mg/kg/day. The microscopic histopathology 
findings correlated with concurrent and expected changes in serum 
clinical chemistry parameters and the severity of toxicity also 
reflected dose-related reductions in animal body weights over the 
dosing phase of this study at the highest test concentrations (1000/600 
mg/kg/day) (Ref. 60).
    Increased kidney weights were observed in both sexes of treated rat 
at >=100 mg/kg-day.
    Vacuolar degeneration/necrosis, granular casts, increased severity 
of tubular basophilia were observed in the

[[Page 81795]]

kidney of both sexes starting at 300 mg/kg/day of the test substance. 
Urinary bladder effects (hypertrophy/hyperplasia of the urothelium) of 
both sexes were also observed starting at 300 mg/kg/day (Ref. 60).
    Under the treatment conditions, developmental effects following in 
utero exposure to MeFBSEA observed in the fetus included decreased 
fetal body weights and increased skeletal variations at doses >=300 mg/
kg-day (LOAEL) in association with decreased maternal body weight (Ref. 
60).
    b. Conclusion. EPA believes there is sufficient evidence to list 
MeFBSEA on the TRI pursuant to EPCRA section 313(d)(2)(B)(ii)(IV) for 
serious or irreversible chronic health effects (hepatotoxicity, renal 
toxicity, and urinary bladder damage).
13. Pyrifluquinazon (CASRN 337458-27-2)
    a. Human health hazard assessment. The Agency has provided 
important endpoints in the following summary. For the full 
toxicological profile, please refer to the respective reference (a 2018 
EPA human health risk assessment for proposed uses of pyrifluquinazon 
(Ref. 61)). In a carcinogenicity test in mice, the LOAEL was found to 
be 27.1/25.0 mg/kg/day [M/F] based on decreased mean body weight in 
males, increased incidences of tactile hair loss in males, endometrial 
hyperplasia of the uterine horn in females, follicular cell hypertrophy 
of the thyroid in males, and subcapsular cell hyperplasia of the 
adrenal in males. Using an uncertainty factor of 10X, the cPAD was 
calculated to be 0.06 mg/kg/day (Ref. 61).
    In a two-generation developmental and reproductive toxicity study 
in rats, the developmental LOAEL was 10 mg/kg/day based on decreased 
anogenital distance (AGD) in males, increased incidences of skeletal 
variations (total), and increased incidences of supernumerary ribs. The 
offspring LOAEL was 10.2 mg/kg/day based on decreased body weight in F2 
female pups (Ref. 61).
    In a 28-day inhalation toxicity study in rats, the portal of entry 
LOAEL was 0.15 mg/L based on an increased incidence of terminal airway 
inflammation in males. The systemic LOAEL was 0.15 mg/L based on 
clinical signs including piloerection and splayed gait, decreased body-
weight gains in both sexes, decreased platelet diameter widths in 
males, as well as increased incidence of centrilobular hepatocyte 
hypertrophy in both sexes (Ref. 61).
    b. Conclusion. EPA believes there is sufficient evidence to list 
pyrifluquinazon on the TRI pursuant to EPCRA section 
313(d)(2)(B)(ii)(I) and (IV) for serious or irreversible: reproductive 
dysfunctions and other chronic human health effects.
14. Tetraconazole (CASRN 112281-77-3)
    a. Human health hazard assessment. The liver and kidney are the 
target organs of tetraconazole toxicity in oral toxicity studies in 
dogs and mice following subchronic and chronic durations: In a 90-day 
oral toxicity study in mice, single liver cell degeneration in males; 
and increased serum glutamic pyruvic transaminase (SGPT) and serum 
glutamic oxaloacetic transaminase (SGOT), decreased BUN levels, 
increased absolute and relative liver weights and presence 
hepatocellular single cell necrosis in females were seen at the LOAEL 
of 16/20 mg/kg/day. In a chronic toxicity study in dogs, increases in 
liver weight and kidney weight, histopathological changes in the liver 
and kidney, and increases in alkaline phosphatase, [gamma]-
glutamyltransferase, alanine aminotransferase and ornithine carbamoyl 
transferase levels in both sexes, increased cholesterol in the male, 
decreased albumin in both sexes, proteinuria and decreased absolute 
terminal body weight in females were seen at the LOAEL of 12.97/14.5 
(M/F) mg/kg/day. Inhalation exposure of rats to tetraconazole to 
resulted in portal-of-entry effects (squamous cell metaplasia of 
laryngeal mucosa and mononuclear cell infiltration) and systemic 
effects (follicular cell hypertrophy of thyroid). The inhalation no-
observed-adverse-effect concentration (NOAEC) is established at 0.159 
mg/L and lowest-observed-adverse-effect concentration (LOAEC) is 0.520 
mg/L based on increased severity of the squamous cell metaplasia of 
laryngeal mucosa (minimal to slight), slight increase in severity of 
mononuclear cell infiltration, minimal epithelial erosion in the 
larynx, slight increase in the lung weights, and increased white blood 
cell counts. The systemic NOAEC is established at 0.0548 mg/L and LOAEC 
is 0.159 mg/L based on increased severity (minimal to slight) of 
thyroid follicular cell hypertrophy in males (Ref. 62).
    In the developmental rat study, an increased incidence of 
supernumerary ribs (associated with 7th cervical vertebrae) was noted 
in the absence of maternal effects (developmental LOAEL = 100 mg/kg/
day). In the two-generation reproduction toxicity study in rats, 
decreased litter and mean pup body weights were noted in offspring at 
the same dose that caused decreased body weights, dystocia, and 
mortality in adult females (offspring, reproductive, and parental/
systemic LOAEL at the highest dose of 35.5/40.6 (M/F) mg/kg/day). 
Effects in parental animals that survived the duration of the study 
were consistent with other studies, such as decreased body weight, 
increased kidney weight, increased liver weight, and hepatocyte 
enlargement (Ref. 62).
    The two-generation reproduction study in rats was selected for the 
chronic dietary endpoint for the general population. An uncertainty 
factor of 100 (10X for interspecies extrapolation, a 10X for 
intraspecies variability, and a 1X Food Quality PA Safety Act safety 
factor) was applied to the NOAEL of 6 mg/kg/day to generate the cPAD of 
0.06 mg/kg/day. The LOAEL is 35.5 mg/kg/day based on decreased litter 
weight and mean pup weight in litters of all generations before weaning 
and decreased mean litter size and number of pups in the F1A 
generation. It is protective of the effects observed in the chronic 
studies in mice, rats, and dogs, as well as the fetal effect observed 
in the developmental study in rats (Ref. 62).
    b. Ecological hazard assessment. Tetraconazole poses risk to 
terrestrial vertebrate and invertebrate taxa (primarily mortality, 
growth or reproduction effects from chronic exposure).
    Chronic exposure of birds resulted in 7.48% and 15.9% reductions in 
14-day old weight and survival, respectively. In a 2-generation 
reproduction study in rats, there was a 9% increase in mortality and a 
2% increase in gestation times at the LOAEL of 5.9 mg a.i./kg-bw/day 
(females) (Ref. 63).
    Available acute toxicity data for fish indicate that tetraconazole 
is moderately toxic to the freshwater Bluegill Sunfish (Lepomis 
macrochirus; LC50=3,850 [micro]g a.i./L) and the estuarine/marine 
Sheepshead Minnow (Cyprinodon variegatus; LC50>3,400 [micro]g a.i./L) 
on an acute exposure basis (Ref. 63).
    In a chronic two-generation life cycle test (MRID 50485802) with 
the freshwater Zebra Fish (Danio rerio), the NOAEC was 80 [micro]g 
a.i./L above which there was a statistically significant (p<0.05) shift 
in sex ratio (i.e., 21.1% increase in the number of males and a 25.1% 
reduction females) compared to controls at the LOAEC of 207 [micro]g 
a.i./L. A chronic early life stage toxicity test with the estuarine/
marine C. variegatus resulted in a NOAEC of 120 [micro]g a.i./L above 
which there were 3.2% and 10.8% reductions in body length and dry 
weight, respectively, at the LOAEC of 240 [micro]g ai/L (Ref. 63).
    Tetraconazole is moderately toxic to the freshwater invertebrate 
waterflea

[[Page 81796]]

(Daphnia magna; EC<INF>50</INF>=2,360 [micro]g a.i./L) and highly toxic 
to the estuarine/marine invertebrate mysid shrimp (Americamysis bahia; 
LC<INF>50</INF>=440 [micro]g a.i./L) on an acute exposure basis. A 
chronic toxicity study of the D. magna resulted in a NOAEC = 190 
[micro]g a.i./L above which there was a 20.9% reduction in reproduction 
in comparison to the control at a LOAEC of 209 [micro]g a.i./L. A 
chronic toxicity study with A. bahia resulted in a NOAEC of 87 [micro]g 
a.i./L above which there was a 21% increase in the time to first brood, 
a 39% reduction in the number of young per female, and 10% decrease in 
male dry weight in comparison to the control at a LOAEC of 180 [micro]g 
a.i./L (Ref. 63).
    Tetraconazole is expected to be persistent in aquatic and soil 
environments and does not have a predominant route of dissipation. 
Tetraconazole is stable to hydrolysis and aerobic soil degradation. The 
aerobic aquatic half-lives ranged from 320 to 382 days. Tetraconazole 
field dissipation half-lives ranged from 91 to 800 days. Tetraconazole 
is stable to anaerobic aquatic metabolism with half-lives greater than 
the experimental period tested (t\1/2\~ 8,123 days) (Ref. 63).
    c. Conclusion. In conclusion, EPA believes there is sufficient 
evidence to list tetraconazole on the TRI pursuant to EPCRA section 
313(d)(2)(B)(ii) for serious or irreversible reproductive dysfunctions 
and other chronic health effects; as well as 313(d)(2)(C)(ii) for 
environmental toxicity and persistence.
15. Triethoxy(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)silane (CAS 
51851-37-7)
    a. Human health hazard assessment. Valid available toxicity data 
are limited to one repeat-dose oral study with a reproductive/
developmental screen (OECD 422 guideline), a subchronic study for which 
EPA only has access to the industry summary(-ies) via ECHA database 
dossiers. The high dose tested was 128 mg/kg-day time weighted average 
(TWA) (initially 150 mg/kg-day was tested and this was reduced to 125 
mg/kg-day for the remainder of the study due to profound toxicity at 
150 mg/kg-day in the first 1-2 weeks of exposure), the medium dose was 
100 mg/kg-day, and the low dose was 50 mg/kg-day. The most sensitive 
toxicity target appears to be the peripheral nervous system. Clinical 
signs at >=100 mg/kg-day included impaired neuromuscular function: 
ataxia, paresis, hypotonia, and reductions in reflexes, positional 
passivity, visual placing, grip strength, and sensitivity to pinching 
the tail. Histological evaluation showed progressive polyneuropathy in 
the peripheral nerves and associated myofiber atrophy/degeneration of 
skeletal muscles at >=100 mg/kg-day (LOAEL). The authors of the study 
summary considered peripheral nerve polyneuropathy a contributing or 
primary cause of moribundity in 17/21 rats that were sacrificed 
moribund in the medium- and high-dose groups. In surviving animals from 
the high-dose group, neurological effects (clinical signs and 
polyneuropathy) persisted after a 14- to 16-day recovery period. No 
clinical signs of neurotoxicity or peripheral nerve damage were 
reported at 50 mg/kg-day (NOAEL). In summaries of acute duration 
studies, no apparent clinical signs of neurotoxicity were reported 
following oral or dermal exposure to 2,000 mg/kg (Ref. 64).
    No direct effects were seen on reproductive viability, as based on 
gonadal cell observations, fertility rate, or pup health (up to 
sacrifice on PND 4) in any of the groups; however, the copulation rate 
was drastically reduced to 43% at the high dose of 128 mg/kg-day. This 
was due to the high mortality prior to mating, neuromuscular 
impairments in surviving rats that impacted mating success, and low 
survival of high-dose dams. Reproductive indices for the medium-dose 
group were similar to controls (therefore the NOAEL = 100 mg/kg-day). 
Due to the high mortality of the high-dose group mentioned previously, 
a LOAEL for reproductive/developmental toxicity could not be determined 
(Ref. 64).
    In the lungs, increases in subacute perivasculitis and interstitial 
edema in the high dose group (TWA of 128 mg/kg-day) were considered a 
contributing cause of moribundity in 5/21 rats. Hepatocellular 
hypertrophy and minimal-to-slight hepatocellular necrosis were observed 
in a few rats (as reported by the summary authors) that were sacrificed 
moribund in the medium and high dose groups (>=100 mg/kg-day). Diffuse 
hypertrophy of the zona fasciculata in the adrenal cortex was 
associated with moribundity in rats in the medium and high dose groups 
(>=100 mg/kg-day). Increases in thymic atrophy were also associated 
with moribundity in the high dose group (Ref. 64).
    By the end of the 54-day study, half of the rats in the high-dose 
group had died. The 22 decedent rats from the medium- and high-dose 
groups were euthanized spanning Days 11 to 30. Exposed rats showed 
increased mortality in males, severe clinical signs of neurotoxicity 
(e.g., ataxia, hypotonia, and paresis; occurred in both sexes but 
earlier in males than in females), decreased maternal body weight and 
body weight gain, and progressive polyneuropathy in both sexes (Ref. 
64).
    b. Conclusion. EPA believes there is sufficient evidence to list 
triethoxy(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)silane on the 
TRI pursuant to EPCRA section 313(d)(2)(B)(ii)(IV) for serious or 
irreversible chronic health effects.
16. Trifluoro(trifluoromethyl) Oxirane (HFPO) (CASRN 428-59-1)
    a. Human health hazard assessment. The most reliable study for HFPO 
is a subchronic inhalation exposure study with reproductive screen in 
rats (OECD 422). Due to increased relative brain weight and 
corresponding brain lesions (neural necrosis and degeneration of 
neuronal fibers) in both sexes after exposure, HFPO is considered 
neurotoxic at >=1,700 mg/m\3\ (Ref. 65). An independent analysis of 
this chemical via a TSCA section 4 test order confirmed the same 
findings regarding the literature and toxic endpoints of HFPO: ``In 
particular, available data from an OECD 422 Combined Repeated Dose 
Toxicity Study with the Reproduction/Developmental Toxicity Screening 
Test in rats showed severe neurotoxicity, including vacuolization and/
or necrosis of brain neuronal cells''. The test order authors ranked 
this study as high confidence in the quality review of all health 
outcome endpoints (Ref. 66). Further, due to significant decreases in 
pup body weight in mid (1,700 mg/m\3\)- and high (TWA 3,660 mg/m\3\)-
exposure groups in the same study, HFPO is expected to be a 
developmental toxicant. Note that a decrease in pup body weight was 
observed at the lowest concentration of 340 mg/m\3\ parental exposure, 
but the decrease was not statistically significant (Ref. 65). The test 
order corroborates findings of reproductive and developmental toxicity 
in the OECD 422 study.
    b. Conclusion. EPA believes there is sufficient evidence to list 
HFPO on the TRI pursuant to EPCRA section 313(d)(2)(B)(ii) and (iv) for 
serious or irreversible nervous system and developmental toxicity 
endpoints.

IV. Chemicals on the TRI List Are Being Reclassified as Chemical 
Categories

    As explained in Unit II.B., EPA is proposing to reclassify certain 
individually listed chemicals as chemical categories. Specifically, EPA 
is proposing to remove the following individually listed chemicals from 
the TRI as they are included in chemical categories being proposed for 
listing (each is listed under the applicable category being proposed).

[[Page 81797]]

    Hexafluoropropylene oxide dimer acid (HFPO-DA), Salts, and Acyl 
Halides Category:
    <bullet> Hexafluoropropylene oxide dimer acid (HFPO-DA, GenX) 
(CASRN 13252-13-6);
    <bullet> Hexafluoropropylene oxide dimer acid ammonium salt (CASRN 
62037-80-3):
    <bullet>Perfluorobutanesulfonic acid (PFBS), Salts, Sulfonyl 
Halides, and Anhydride Category;
    <bullet> Perfluorobutanesulfonate (CASRN 45187-15-3);
    <bullet> Perfluorobutanesulfonic acid (PFBS) (CASRN 375-73-5);
    <bullet> Potassium perfluorobutane sulfonate (CASRN 29420-49-3);
    <bullet> Perfluorobutanoic acid (PFBA), Salts, Acyl Halides, and 
Anhydride Category;
    <bullet> Ammonium perfluorobutanoate (CASRN 10495-86-0);
    <bullet> Perfluorobutanoate (CASRN 45048-62-2);
    <bullet> Perfluorobutanoic acid (PFBA) (CASRN 375-22-4);
    <bullet> Potassium heptafluorobutanoate (CASRN 2966-54-3);
    <bullet> Sodium perfluorobutanoate (CASRN 2218-54-4);
    <bullet> Perfluorodecanoic acid (PFDA), Salts, Acyl Halides, and 
Anhydride Category:
    <bullet> Perfluorodecanoic acid (PFDA) (CASRN 335-76-2);
    <bullet> Ammonium perfluorodecanoate (PFDA NH4, CASRN 3108-42-7) 
(this chemical is not currently listed in the CFR, but pursuant to NDAA 
section 7321(c) this chemical will be on the TRI list with an effective 
date of January 1, 2025, in response to a July 2024 IRIS publication on 
PFDA; accordingly, EPA plans to update the CFR in 2025 to include this 
chemical).
    <bullet> Sodium perfluorodecanoate (PFDA-Na, CASRN 3830-45-3) (this 
chemical is not currently listed in the CFR, but pursuant to NDAA 
section 7321(c) this chemical will be on the TRI list with an effective 
date of January 1, 2025, in response to a July 2024 IRIS publication on 
PFDA; accordingly, EPA plans to update the CFR in 2025 to include this 
chemical);
    Perfluorododecanoic acid (PFDoA), Salts, Acyl Halides, and 
Anhydride Category:
    <bullet> Perfluorododecanoic acid (PFDoA) (CASRN 307-55-1);
    Perfluorohexanesulfonic acid (PFHxS), Salts, and Sulfonyl Halides, 
and Anhydride Category:
    <bullet> Perfluorohexanesulfonic acid (PFHxS) (CASRN 355-46-4);
    <bullet> 1-Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6-
tridecafluoro-, ammonium salt (CASRN 68259-08-5)
    <bullet> 1-Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6-
tridecafluoro-, compd. With 2,2'-iminobis[ethanol] (1:1) (CASRN 70225-
16-0)
    <bullet> 1-Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6-
tridecafluoro-, potassium salt (CASRN 3871-99-6)
    <bullet> Perfluorononanoic acid (PFNA), Salts, Acyl Halides, and 
Anhydride Category:
    <bullet> Perfluorononanoic acid (PFNA) (CASRN 375-95-1);
    Perfluorooctanesulfonic acid (PFOS), Salts, Sulfonyl Halides, and 
Anhydride Category:
    <bullet> Lithium (perfluorooctane)sulfonate (CASRN 29457-72-5);
    <bullet> Potassium perfluorooctanesulfonate (CASRN 2795-39-3);
    <bullet> 1-Octanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
heptadecafluoro-, ammonium salt (CASRN 29081-56-9);
    <bullet> Ethanaminium, N,N,N-triethyl-, salt with 
1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-1-octanesulfonic acid 
(1:1) (CASRN 56773-42-3);
    <bullet> Perfluorooctylsulfonyl fluoride (CASRN 307-35-7);
    <bullet> Perfluorooctanesulfonic acid (PFOS) (CASRN 1763-23-1);
    <bullet> Perfluorooctanoic acid (PFOA), Salts, Acyl Halides, and 
Anhydride Category:
    <bullet> Perfluorooctanoic acid (PFOA) (CASRN 335-67-1);
    <bullet> Silver(I) perfluorooctanoate (CASRN 335-93-3);
    <bullet> Sodium perfluorooctanoate (CASRN 335-95-5);
    <bullet> Potassium perfluorooctanoate (CASRN 2395-00-8);
    <bullet> Ammonium perfluorooctanoate (CASRN 3825-26-1);
    <bullet> Chromium(III) perfluorooctanoate (CAS RN 68141-02-6); and
    <bullet> Octanoyl fluoride, pentadecafluoro- (CASRN 335-66-0).
    EPA would only take final action to remove the individually listed 
chemicals if the chemical categories that encompass the chemicals are 
added to the TRI through a final agency action.
    Category reporting would require the facility to submit only one 
form for a category, which accounts for activities and quantities 
associated with all member chemicals. Facilities would first need to 
calculate the total weight of all chemicals that fall under a category 
for each threshold activity (i.e., manufacture, process, and otherwise 
use), and compare the totals to the applicable threshold(s). If a 
facility exceeds one or more reporting thresholds (i.e., for 
manufacture, process, and otherwise use) for a proposed PFAS category, 
it would be required to report the aggregated quantities of releases 
and other waste management activities of the chemicals in that chemical 
category.
    For example, a facility that manufactures 75 pounds of 
perfluorobutanesulfonyl fluoride (CASRN 375-72-4) and 50 pounds of 
potassium perfluorobutane sulfonate (CASRN 29420-49-3) would exceed the 
100-pound reporting threshold for the PFBS, Salts, Sulfonyl Halides, 
and Anhydride category. Therefore, the facility would need to submit 
one form for the PFBS category. On this TRI reporting form for the PFBS 
category, the facility would aggregate information for all members of 
the PFBS category.
    Note that, as this proposed rule is written, it is possible for a 
PFAS category to be inclusive of a PFAS that has a CBI claim related to 
its identity, and in which case, it would need to be reported as part 
of that category. For reviewing toxicity data to support TRI listings, 
the Agency did not consider chemicals with CBI claims regarding their 
identities as individual chemical listing candidates or as chemicals 
for which toxicity information would be directly considered for listing 
purposes. However, it is conceivable that there may be a form of an 
acid (e.g., a salt) that would fit into a category being proposed, as 
the proposed categories are open-ended and not limited to a discrete 
list of chemicals. Because reporting a TRI category only requires a 
facility to report the category name and not the specific individual 
members, it's possible a facility may meet reporting requirements for a 
PFAS category based on activities involving a PFAS with a CBI claim. 
However, the reporting form would only reveal the broader category name 
and would not divulge the individual chemicals of that category 
involved. The EPA notes that it does not anticipate this scenario to be 
likely.

V. Reporting Threshold for PFAS EPA Is Proposing To Add to the TRI

    For PFAS added to the EPCRA section 313 toxic chemical list under 
the provisions of NDAA section 7321(b) and (c), Congress established a 
manufacture, processing, and otherwise use reporting threshold of 100 
pounds for each of the listed PFAS. The 100-pound reporting threshold 
reflects a concern for small quantities of PFAS due to their toxicity 
and persistence in the environment. The PFAS proposed for addition in 
this action have similar properties as those added by the other 
sections of the NDAA. EPA finds that it is appropriate to maintain 
consistency for all chemicals added to TRI pursuant to the NDAA (i.e., 
those PFAS previously added by NDAA section 7321(b) and

[[Page 81798]]

(c)). Therefore, EPA is proposing to establish a 100-pound manufacture, 
processing, and otherwise use reporting threshold for the PFAS proposed 
for addition in this action. However, EPA is soliciting comment (see 
Unit VII.) on whether to implement a different reporting threshold 
(i.e., whether a different threshold would equally or more capably 
obtain reporting on a substantial majority of total releases of these 
PFAS being proposed for addition to the TRI list). Similarly, should 
EPA implement a threshold other than 100 pounds for these PFAS, EPA is 
soliciting comment on whether to modify the reporting threshold for 
other TRI-listed PFAS accordingly.
    Facilities are advised that some PFAS being proposed for listing in 
this action may fall under multiple TRI chemical categories. For 
example, silver heptafluorobutyrate (CASRN 3794-64-7) is being proposed 
as a member of the PFBA, Salts, Acyl Halides, and Anhydride category. 
Because of the silver constituent in the compound, it is also included 
in the silver compounds category. In cases where a TRI facility has a 
compound with constituents in two listed chemical categories, the 
facility must consider the total amount of the compound manufactured, 
processed, or otherwise used that must be applied to the reporting 
threshold for each category separately. Using the example of silver 
heptafluorobutyrate, a facility which has manufactured that compound 
must apply the same compound to threshold determinations for each 
listed category separately and determine whether that amount 
manufactured meets the reporting threshold for PFBA compounds (100 lbs 
manufactured) and for silver compounds (25,000 lbs manufactured), 
independently. This is consistent with longstanding EPA guidance on 
reporting for compounds covered by multiple chemical categories.

VI. Designating PFAS Being Proposed for Addition as Chemicals of 
Special Concern

    EPA is proposing to add all of the PFAS described in Unit III. to 
the list of chemicals of special concern at 40 CFR 372.28. EPA first 
created the list of chemicals of special concern to increase the 
utility of TRI data by ensuring that the data collected and shared 
through TRI are relevant and topical (64 FR 58666, 58668 October 29, 
1999 (FRL-6389-11) (Ref. 67). EPA lowered the reporting thresholds for 
chemicals of special concern because even small quantities of releases 
of these chemicals can be of concern. The first chemicals that were 
added to the list of chemicals of special concern were those identified 
as persistent, bioaccumulative and toxic (PBT) which, except for the 
dioxin and dioxin-like compounds category, have reporting thresholds of 
either 10 or 100 pounds depending on their persistent and 
bioaccumulative properties (Ref. 67). Chemicals of special concern are 
also excluded from the de minimis exemption (for both TRI reporting and 
TRI supplier notification requirements), may not be reported on Form A 
(Alternate Threshold Certification Statement), and have limits on the 
use of range reporting.
    The de minimis exemption allows facilities to disregard small 
concentrations of TRI chemicals not classified as chemicals of special 
concern in mixtures or other trade name products when making threshold 
determinations and release and other waste management calculations. The 
de minimis exemption does not apply to the manufacture of a TRI 
chemical except if that chemical is manufactured as an impurity and 
remains in the product distributed in commerce, or if the chemical is 
imported below the applicable de minimis level. The de minimis 
exemption does not apply to a byproduct manufactured coincidentally as 
a result of manufacturing, processing, otherwise using, or any waste 
management activities. Further, facilities covered by TRI supplier 
notification requirements (40 CFR 372.45) may also use the de minimis 
exemption, except for chemicals of special concern.
    The Form A provides facilities that otherwise meet TRI-reporting 
thresholds the option of certifying on a simplified reporting form 
provided that they do not exceed 500 pounds for the total annual 
reportable amount (defined subsequently in this document) for that 
chemical, and that their amounts manufactured, processed, or otherwise 
used do not exceed 1 million pounds. All chemicals of special concern 
(except certain instances of reporting lead in stainless steel, brass, 
or bronze alloys) are excluded from Form A eligibility. Form A does not 
include any information on releases or other waste management. Nor does 
it include source reduction information or any other chemical-specific 
information other than the identity of the chemical.
    For certain data elements (Part II, Sections 5, 6.1, and 6.2 of 
Form R), for chemicals not classified as chemicals of special concern, 
the reportable quantity may be reported either as an estimate or by 
using the range codes that have been developed. Currently, TRI 
reporting provides three reporting ranges: 1-10 pounds, 11-499 pounds, 
and 500-999 pounds.
    In the preamble to the 1999 rule establishing the de minimis 
exemption, EPA outlined the reasons for promulgating the de minimis 
exemption (e.g., that facilities had limited access to information and 
that low concentrations would not contribute to the activity threshold) 
and determined that those rationales did not apply to chemicals of 
special concern. Id. At 58670. Among the reasons provided, EPA 
explained that even minimal releases of persistent bioaccumulative 
chemicals may result in significant adverse effects that can reasonably 
be expected to significantly contribute to exceeding the proposed lower 
threshold. Id. EPA also determined that facilities reporting on 
chemicals of special concern could not avail themselves of Form A 
reporting because the information provided on Form As is ``insufficient 
for conducting analyses'' on chemicals of special concern and would be 
``virtually useless for communities interested in assessing risk from 
releases and other waste management'' of such chemicals (i.e., the Form 
A does not include estimated release and other waste management 
quantities). Id. Lastly, EPA determined that range reporting was not 
appropriate for chemicals of special concern because the use of ranges 
could misrepresent data accuracy for PBT chemicals because the low or 
the high-end range numbers may not really be that close to the 
estimated value. Id. For the full discussion, see ``Persistent 
Bioaccumulative Toxic (PBT) Chemicals; Lowering of Reporting Thresholds 
for Certain PBT Chemicals; Addition of Certain PBT Chemicals; Community 
Right-to-Know Toxic Chemical Reporting'' (Proposed rule (64 FR 688, 
January 5, 1999 (FRL-6032-3)) and Final rule (64 FR 58666, October 29, 
1999 (FRL-6389-11) (Ref. 67)).
    EPA recently finalized a rulemaking (88 FR 74360; (Ref. 68)) to 
categorize PFAS added to EPCRA section 313 by NDAA section 7321(b) and 
(c) as chemicals of special concern, listing such PFAS in 40 CFR 
372.28. In that rulemaking, EPA highlighted that the NDAA set a 100-
pound reporting threshold for PFAS added by NDAA section 7321(b) and 
(c), which indicates a concern for small quantities of such PFAS. 
Further, EPA explained that the availability of certain burden 
reduction tools (i.e., de minimis levels, Form A, and range reporting) 
is not justified for chemicals where there is a concern for small 
quantities (88 FR 74360, 74363). This same rationale applies to the 
PFAS being proposed for addition in this rulemaking action.

[[Page 81799]]

    Further, due to the strength of the carbon-fluorine bonds, EPA 
noted in the October 31, 2023, rulemaking that many PFAS can be very 
persistent in the environment (Ref. 3, 4, 69). Persistence in the 
environment allows PFAS concentrations to build up over time; thus, 
even small releases can be of concern. As with PBT chemicals, 
permitting reporting facilities to continue to rely on the burden 
reduction tools (de minimis levels, Form A, and range reporting) would 
eliminate reporting on potentially significant quantities of the listed 
PFAS. As explained in more detail subsequently in this document, EPA's 
rationale for eliminating these burden reduction tools for PBT 
chemicals (64 FR 714-716) applies equally well to PFAS.
    The de minimis exemption allows facilities to disregard 
concentrations of TRI listed chemicals below 1% (0.1% for carcinogens) 
in mixtures or other trade name products they import, process, or 
otherwise use in making threshold calculations and release and other 
waste management determinations. Since the de minimis level is based on 
relative concentration rather than a specific amount, the application 
of this exemption to PFAS listed under NDAA section 7321(d) could allow 
significant quantities of such PFAS to be excluded from TRI reporting 
by facilities. For example, if a facility imports, processes, or 
otherwise uses 100,000 pounds of a mixture or trade name product that 
contains 0.5% of a listed PFAS, then 500 pounds (or five times the 
reporting threshold) would be disregarded. This exemption thus is 
inconsistent with a concern for small quantities of PFAS. Many PFAS are 
used in products at levels below the established de minimis levels 
(Ref. 5, 70). If EPA were to allow entities to apply the de minimis 
exemption with respect to PFAS, facilities would be able to discount 
such uses when determining whether an applicable threshold has been met 
to trigger reporting.
    Additionally, in EPA's recent rulemaking to categorize PFAS already 
on the TRI list as chemicals of special concern, EPA also eliminated 
the use of the de minimis exemption for supplier notification 
requirements for all chemicals of special concern (Ref. 2). EPA 
determined that allowing facilities covered by the TRI supplier 
notification requirements to continue the use of the de minimis 
exemption for supplier notifications for chemicals of special concern 
limited TRI reporting facilities' knowledge of potentially reportable 
quantities of chemicals of special concern in their on-site activities. 
Many PFAS are used in products below the established de minimis levels 
(Ref. 5, 70) which results in downstream users of those products not 
knowing they are receiving a product that contains a TRI-reportable 
PFAS. EPA concluded that it is important and necessary to eliminate the 
supplier notification de minimis exemption for PFAS added to the TRI 
list pursuant to NDAA section 7321(b) and (c); otherwise, the Agency 
may fail to collect information on amounts of PFAS that significantly 
exceed the reporting threshold. The same logic extends to PFAS being 
proposed in this action pursuant to NDAA section 7321(d).
    As described previously, the Form A provides certain covered 
facilities the option of submitting a substantially shorter form with a 
reduced reporting burden (Ref. 71). This means that if facilities that 
are required to report data on PFAS were able to file a Form A, those 
facilities would not be providing specific quantity data on up to 500 
pounds of a listed PFAS (five times the reporting threshold). While the 
Form A does provide some general information on the quantities of the 
chemical that the facility manages as waste, this information may be 
insufficient for conducting analyses on PFAS and may be less meaningful 
for communities interested in assessing risk from releases of PFAS. The 
threshold category for amounts managed as waste does not include 
quantities released to the environment as a result of remedial actions 
or catastrophic events not associated with production processes 
(section 8.8 of Form R). This means that if facilities that are 
required to report data on PFAS were to qualify to file a Form A, they 
would not be providing specific quantity data on up to 500 pounds of a 
listed PFAS (five times the reporting threshold). Given that even small 
quantities of PFAS may result in elevated concentrations in the 
environment, EPA believes it would be inappropriate to allow a 
reporting option that would exclude information on some releases. For 
reporting year 2021, approximately 10% of the reporting forms submitted 
for the listed PFAS were Form As (i.e., reporting for TRI reflects 87 
active reporting forms of which 78 were Form Rs and 9 were Form As).
    For these reasons, as well as to align these proposed PFAS 
additions with the PFAS that the NDAA added directly to the TRI 
chemical list, eliminating the availability of the use of Form A for 
PFAS is consistent with a concern for understanding small quantities of 
PFAS.
    For TRI-listed chemicals, other than chemicals of special concern, 
releases and off-site transfers for further waste management of less 
than 1,000 pounds can be reported using ranges or as a whole number. 
The reporting ranges are: 1-10 pounds; 11-499 pounds; and 500-999 
pounds. For larger releases and offsite transfers for further waste 
management of the toxic chemical, the facility must report the whole 
number. Use of ranges could reduce data accuracy because the low- or 
the high-end range numbers may not be that close to the estimated 
value, even taking into account inherent data errors (i.e., errors in 
measurements and developing estimates). For PFAS, it is important to 
have accurate data regarding the amount released even when the 
quantities are relatively small, since concern may be tied to even 
small quantities of a substance. This issue was apparent for PFAS for 
reporting year 2021 since much of the data reported was for less than 
1,000 pounds.
    EPA anticipates that the elimination of these burden reduction 
tools will increase the amount and quality of data collected for PFAS 
and is consistent with the concern for small quantities of PFAS (Ref. 
2). Per the Ratio-Based Burden Methodology, the Form R unit burden per 
chemical is 35.70516 hours compared to the Form A unit burden per 
chemical of 22.0 hours. With a weighted average wage rate of $79.23 and 
a first-time filer factor of 2.1, the Form R unit cost per chemical is 
$5,941 and the Form A unit cost per chemical is $3,661. To avoid 
understating per-firm impacts, EPA assumes each small entity will 
submit two Form Rs. Thus, small entities are expected to incur $11,883 
in costs for the first year compared to $7,322 if they were allowed to 
submit two Form As instead.

VII. Clarifying the Framework for NDAA Section 7321(c) Additions

    Additional PFAS are automatically added to the TRI list on an 
annual basis by NDAA section 7321(c). Specifically, PFAS that meet the 
criteria in NDAA section 7321(c) are deemed added to the TRI list on 
January 1 of the year after those criteria are met. The criteria that 
lead to listing pursuant to NDAA section 7321(c) are identified as 
follows:
    <bullet> Final Toxicity Value. The date on which the Administrator 
finalizes a toxicity value for the PFAS or class of PFAS;
    <bullet> Significant New Use Rule (SNUR). The date on which the 
Administrator makes a covered determination for the PFAS or class of 
PFAS;
    <bullet> Addition to Existing SNUR. The date on which the PFAS or 
class of PFAS is added to a list of substances covered by a covered 
determination;

[[Page 81800]]

    <bullet> Addition as an Active Chemical Substance. The date on 
which the PFAS or class of PFAS to which a covered determination 
applies is:
    <bullet> Added to the list published under TSCA section 8(b)(1) 
(i.e., TSCA Inventory) and designated as an active chemical substance 
under TSCA section 8(b)(5)(A); or
    <bullet> Designated as an active chemical substance under TSCA 
section 8(b)(5)(B) on the TSCA Inventory.
    For purposes of identifying PFAS that are automatically added to 
the TRI list following an event specified under NDAA section 7321(c), 
EPA considers any chemical to be a PFAS if it is identified by EPA as a 
PFAS in the event that triggers its listing pursuant to NDAA section 
7321(c). This approach recognizes that different programs may have 
reason to use different definitions of PFAS and that definitions of 
PFAS may evolve. This approach is also consistent with the language 
used in NDAA section 7321(c), which deems chemicals included to TRI 
following an EPA action related to PFAS without limiting or defining 
what is meant by PFAS.
    The first update rule identifying PFAS that met the NDAA section 
7321(c) criteria during 2020 was published on June 3, 2021 (86 FR 
29698) (FRL-10022-25)). NDAA section 7321(c) is self-implementing in 
that PFAS subject to the activities described previously are directly 
added to the TRI list with an effective date of January 1 of the year 
following the date on which the activity occurred. That is, no 
rulemaking is required to effectuate the addition, though EPA has 
promulgated associated rules to update 40 CFR 372.65 to include any 
such PFAS added to the TRI list.
    To date, EPA's updates to 40 CFR 372.65 have only included a PFAS 
if the CASRN associated with the PFAS was specifically listed in a 
triggering event, and if EPA, as part of the triggering event, 
explicitly identified that substance as a PFAS. For instance, in 
December 2022, EPA published an IRIS toxicity assessment for 
perfluorobutanoic acid (PFBA, CASRN 375-22-4) and related salts (Ref. 
25). The assessment stated that the toxicity value derived for PFBA 
also applies to PFBA's salts, providing the following as examples in 
the document: sodium perfluorobutanoate (CASRN 2218-54-4), potassium 
heptafluorobutanoate (CASRN 2966-54-3), ammonium perfluorobutanoate 
(CASRN 10495-86-0), and perfluorobutanoate (CASRN 45048-62-2). Thus, 
pursuant to NDAA section 7321(c), EPA promulgated a final rule in 2023 
(88 FR 41035; June 23, 2023) to update the list of TRI chemicals at 40 
CFR 372.65 to include each of the aforementioned PFAS individually.
    The approach described above to list perfluorobutanoic acid and its 
salts is in tension with the approach proposed in this notice to list a 
PFAS acid along with its salts and/or acyl/sulfonyl halides and 
anhydride as a category. Applying the approach described in this 
proposal to list certain PFAS as TRI chemical categories (i.e., a 
category comprised of the acid, associated salts, and acyl/sulfonyl 
halides) to PFAS automatically added to TRI by NDAA section 7321(c) 
would result in consistent TRI listings so that all acids and 
associated salts and acyl/sulfonyl halides would be TRI-listed as 
categories. If PFAS automatically added to TRI due to the triggering 
actions were not listed similarly at the time of their addition to the 
TRI list as the PFAS chemical categories being proposed in this 
rulemaking, inconsistencies would arise with how NDAA-added PFAS are 
reported. This would complicate the reporting scheme and introduce 
inconsistencies in the reported data, thereby burdening EPA, reporting 
entities, and other TRI data users due to this lack of consistency. 
Further adding to the TRI list in the CFR only those CASRNs identified 
as examples in an action that triggers the TRI listing could 
potentially leave some PFAS added to the TRI by NDAA section 7321(c) 
off the TRI list in the CFR creating confusion for the regulated 
community. For example, where a triggering action provides examples of 
the CASRNs covered, but does not list all of the CASRNs covered 
individually, EPA's update to the CFR could leave off related PFAS that 
were covered by the triggering event but were not listed as examples of 
covered substances (e.g., where a document that finalizes a toxicity 
value identifies specific chemical names/CASRNs as well as states that 
the toxicity value applies to salts of the given chemical). 
Additionally, NDAA section 7321(c) provides for the addition of ``a 
perfluoroalkyl or polyfluoroalkyl substance'' as well as a ``class of 
perfluoroalkyl or polyfluoroalkyl substances.'' Given the TRI context 
for NDAA section 7321(c), interpreting ``class of perfluoroalkyl or 
polyfluoroalkyl substances'' to mean that a TRI chemical category is 
created for PFAS and associated chemicals (e.g., salts and/or acyl/
sulfonyl halides) when a finalized toxicity value applies aligns with 
the statutory language.
    Thus, where the triggering action is applicable to both the acid 
and associated salts and/or acyl/sulfonyl halides, EPA is proposing 
regulatory text that would designate each PFAS added in the future 
pursuant to NDAA section 7321(c) as a chemical category of the acid and 
associated salts and acyl/sulfonyl halides. Specifically, if EPA 
includes language as part of the NDAA section 7321(c) triggering action 
(e.g., finalizing a toxicity value, or adding to an existing SNUR) that 
the action is applicable to related chemicals (e.g., by naming one or 
more associated salt(s), acyl/sulfonyl halide(s), or similar associated 
compound), then EPA will interpret the action to be a triggering event 
under NDAA section 7321(c) for all identified types of PFAS (i.e., the 
acid, salts, and acyl/sulfonyl halides) and those PFAS will be 
automatically added to the TRI list as a chemical category. For 
example, if EPA publishes a final toxicity value for a given PFAS and 
its salts (by either specifying the CASRNs for at least some of the 
associated salts or providing a general statement that the toxicity 
value applies to salts associated with the chemical), the resultant 
addition to the TRI list will be a chemical category comprising of that 
PFAS (acid) as specified in the published final toxicity value and its 
associated salts and acyl/sulfonyl halides. EPA requests comment on 
this approach.
    Further, EPA notes that certain final toxicity values may omit 
related salts, acyl/sulfonyl halides, and anhydrides that have at least 
the same toxicity as the acid, if not more, due to the additional 
contributions to the overall chemical's toxicity from substituents 
unrelated to the acid. Generally, provided the final toxicity value 
indicates that it applies to salts and other forms of the chemical then 
all such compounds would be included in the resulting TRI chemical 
category. Where the final toxicity value only applies to certain 
chemicals but omits some due to additional contributions of toxicity, 
the resulting TRI chemical category will also include such chemicals. 
To use the same example of the 2022 IRIS assessment for PFBA and its 
related salts: the assessment stated it would not necessarily apply to 
non-alkali metal salts of PFBA, such as silver heptafluorobutyrate 
(CASRN 3794-64-7) due to the metal's PFBA-independent contribution to 
toxicity. For PFBA, the finalized toxicological review document 
determined that ``due to the possibility of PFBA-independent 
contributions of toxicity'', the final toxicity value excluded silver 
heptafluorobutyrate. Thus, because the toxicity of silver 
heptafluorobutyrate is at least comparable to that of the final 
toxicity

[[Page 81801]]

value for PFBA, silver heptafluorobutyrate would be included in the 
resulting TRI PFAS category for PFBA.
    Put another way, where a PFAS final toxicity value omits specific 
substances, the explicitly omitted PFAS generally would not be deemed 
to be part of the category added to the TRI by the triggering event 
unless the reason for the omission is due to the identified substances 
as having additional toxicological concerns. Where the final toxicity 
value indicates that it only applies to a set of specifically 
identified chemicals, and not to a broader set of similar chemicals 
(e.g., salts) then the chemical category deemed added to the TRI by 
NDAA section 7321(c) generally would include only those specifically 
identified PFAS.
    EPA requests comment on this approach and on an alternate approach 
under which salts and halides omitted from the category would be 
excluded regardless of whether the finalized publication providing the 
toxicity value indicates that the toxicity concern would similarly 
apply to salts and/or halides. If this latter approach were adopted, 
EPA would plan to subsequently add the salts and halides to TRI through 
a separate rulemaking.
    Additionally, NDAA section 7321(c) effectuates TRI listings based 
on certain EPA activities that may include the identities (name and/or 
CASRN) of ions (i.e., cations/anions). Accordingly, such (an)ions have 
been added to the TRI (i.e., perfluorobutanoate (CASRN 45048-62-2)). 
However, EPA has previously indicated that an ion does not meet the 
definition of a chemical for purposes of listing on the EPCRA section 
313 list (59 FR 61432, 61460 (FRL-4922-2)) (Ref. 11). EPA considers the 
addition of an ion, or anion, of a chemical as being, in effect, an 
addition of a category of such compounds that dissociate in water 
(e.g., salts). To align the listing of such (an)ions with longstanding 
TRI policy and to ensure consistent reporting of NDAA-added PFAS, EPA 
proposes to list any (an)ion identified by a NDAA section 7321(c) 
action as part of a category for the associated acid, as is being 
proposed for other PFAS in this rulemaking.
    In NDAA section 7321(c)(1)(A)(i), Congress provided that substances 
are added to TRI as of January 1 of the year after the Administrator 
``finalizes a toxicity value for the perfluoroalkyl or polyfluoroalkyl 
substance or class of perfluoroalkyl or polyfluoroalkyl substances.'' 
Congress did not, however, define the term ``toxicity value.'' Nor did 
Congress indicate what EPA activities or publications might constitute 
finalized toxicity values for purposes of this provision. EPA has not 
previously articulated an interpretation of the term ``toxicity value'' 
as it relates to NDAA section 7321(c)(1)(A)(i). In the absence of a 
statutory definition for ``toxicity value'', EPA assumes Congress 
intended to use the term as it is most commonly used in the scientific 
community. For example, the California Department of Toxic Substances 
Control defines the ``noncancer toxicity value'' as ``the amount of a 
chemical or contaminant that a person can ingest or breathe every day 
for a lifetime without any expected adverse health effects.'' (Ref. 
72). EPA has previously described toxicity values and examples of 
toxicity values: ``Toxicity values (including reference doses [RfD], 
reference concentrations [RfC], cancer slope factors, and inhalation 
unit risks) needed for use in human health risk assessment are 
generally derived by reviewing available dose-response data in animals 
or humans, selecting a point of departure in the data that is judged 
most suitable, and adjusting for associated uncertainties'' (Ref. 73). 
EPA believes it is most consistent with the plain scientific meaning of 
``toxicity value'' to interpret the term in this context as referring 
to the analysis and establishment of a value at which adverse effects 
of a substance may occur or a value at which adverse effects of a 
substance are not anticipated to occur. EPA produces various types of 
toxicity assessments that provide toxicity values. These toxicity 
assessments typically include hazard identification, dose-response 
assessment, and--as examples--derive ``toxicity values'' for adverse 
noncancer effects (called oral reference doses [RfDs], inhalation 
reference concentrations [RfCs]) and/or cancer effects (called cancer 
slope factors [CSFs], inhalation unit risk [IURs]) after chronic and/or 
subchronic exposure and determine cancer descriptors when cancer data 
are available. Listed below are EPA events considered to provide 
``toxicity values.''
    To assist stakeholders in understanding how EPA interprets NDAA 
section 7321(c), EPA is proposing to provide a list of EPA events which 
the Agency is interpreting as ``finaliz[ing] a toxicity value for the 
perfluoroalkyl or polyfluoroalkyl substance or class of perfluoroalkyl 
or polyfluoroalkyl substances'' as used in NDAA section 
7321(c)(1)(A)(1). These EPA events analyze and establish a value at 
which adverse effects of a substance may occur or a value at which 
adverse effects of a substance are not anticipated to occur. These 
values can be finalized by the Agency through the following types of 
events which, would trigger addition of the PFAS or class of PFAS to 
TRI under NDAA section 7321(c):
    <bullet> EPA's IRIS Program develops human health assessments that 
identify and characterize health effects information on environmental 
chemicals to which the public may be exposed, including derivation of 
toxicity values. The publication of a final IRIS assessment on the EPA 
website that provides a toxicity value for one or more PFAS would 
constitute a triggering event for those PFAS under NDAA 
7321(c)(1)(A)(1). Each IRIS assessment can cover a chemical, a group of 
related chemicals, or a complex mixture. IRIS assessments are an 
important source of toxicity information used by EPA, state and local 
health agencies, other federal agencies, and international health 
organizations. IRIS assessments provide various types of toxicity 
values for health effects resulting from chronic exposure to chemicals, 
including reference concentrations (RfC) (an estimate of a continuous 
inhalation exposure to the human population that is likely to be 
without an appreciable risk of deleterious effects during a lifetime), 
reference dose (RfD) (an estimate of a daily oral exposure to the human 
population that is likely to be without an appreciable risk of 
deleterious effects during a lifetime), and cancer descriptions 
(including how likely the substance is to be carcinogenic as well as 
estimates of the increased cancer risk from oral and inhalation 
exposures). A final IRIS assessment, thus, provides toxicity values for 
a chemical. Publication of a final IRIS assessment on a PFAS would 
cause that PFAS, if not already on the TRI list, to be added to the TRI 
list pursuant to NDAA 7321(c)(1)(A)(1).
    <bullet> EPA's Provisional Peer-Reviewed Toxicity Values (PPRTVs) 
Program develops assessments which provide toxicity information and 
toxicity values for the Superfund Program (which is responsible for 
cleaning up some of the nation's most contaminated land and responding 
to environmental emergencies, oil spills and natural disasters). The 
publication of a final assessment on the EPA website that provides a 
toxicity value for one or more PFAS would constitute a triggering event 
for those PFAS. The PPRTV Program supports the Agency's mission to 
protect human health and the environment by identifying and 
characterizing the health hazards of--and providing an important source 
of toxicity information and toxicity values

[[Page 81802]]

for--chemicals of concern to the Superfund Program. PPRTV assessments 
are developed in response to requests from EPA's Superfund Program to 
the Superfund Health Risk Technical Support Center (STSC) within EPA's 
Office of Research and Development's (ORD's) Center for Public Health 
and Environmental Assessment (CPHEA). PPRTVs are derived after a review 
of the relevant scientific literature and using Agency methodologies, 
practices, and guidance for the development of toxicity values (e.g., 
oral RfDs, inhalation RfCs, provisional oral slope factors (p-OSF), and 
provisional inhalation unit risks (p-IUR)). A final PPRTV, thus, 
provides toxicity values for a chemical. Publication of a final PPRTV 
on a PFAS would cause that PFAS, if not already on the TRI list, to be 
added to the TRI list pursuant to NDAA 7321(c)(1)(A)(1).
    <bullet> EPA develops EPA Transcriptomic Assessment Products (ETAP) 
for chemicals lacking traditional toxicity testing data. Using 
transcriptomics, which measures gene activity, ETAP determines the 
daily dose of a chemical where there is likely no appreciable human 
health risk. More specifically, an ETAP provides toxicity values by 
correlating gene activity from short-term transcriptomic studies with 
toxicological responses from chronic toxicity tests. The measured gene 
activity is used to identify doses that cause toxicity. EPA follows a 
standard methodology for performing the studies and developing the 
assessments. ETAP reports provide a transcriptomic reference value 
(TRV), an estimate of a daily oral dose to the human population that is 
likely to be without appreciable risk of adverse non-cancer health 
effects over a lifetime. A final ETAP report, thus, provides toxicity 
values for a chemical. Publication of a final ETAP report on a PFAS 
would cause that PFAS, if not already on the TRI list, to be added to 
the TRI list pursuant to NDAA 7321(c)(1)(A)(1).
    <bullet> EPA prepares toxicity values to support pesticide 
registrations or review of registrations pursuant to FIFRA section 3. 
Before manufacturers can sell pesticides in the U.S., EPA must evaluate 
the pesticides thoroughly to ensure that they meet federal safety 
standards for registration. The registration process includes the 
submission and evaluation of data pertaining to the identity, 
composition, toxicity, exposure, and environmental fate of each 
pesticide. Pursuant to FIFRA, EPA assesses a variety of potential human 
health and environmental effects associated with use of the pesticide 
product for which registration has been requested, or for which 
registration review is ongoing. This includes developing risk 
assessments that evaluate the potential for harm to humans, wildlife, 
fish, and plants, including endangered species and non-target 
organisms, and which may derive toxicity values such as a population-
adjusted dose (PAD) or RfD. Pesticide registration reviews must address 
several factors before establishing a tolerance, including but not 
limited to: cumulative effects from exposure to pesticides that share a 
mechanism of toxicity; whether the pesticide produces human health 
effects similar to effects caused by naturally-occurring estrogen or 
other endocrine-disruption effects; and whether infants, children, or 
other sensitive subpopulations are more susceptible due to exposure to 
the pesticide. Publication of a final risk assessment prepared in 
support of a pesticide registration or registration review decision for 
a PFAS would cause that PFAS if not already on the TRI list to be added 
to the TRI list pursuant to NDAA 7321(c)(1)(A)(1).
    <bullet> EPA derives toxicity values pursuant to TSCA section 6, 
which requires EPA to develop risk evaluations on chemicals designated 
as high-priority substances. Risk evaluations include the hazards, 
exposures, conditions of use, and potentially exposed or susceptible 
subpopulations. Publication of a TSCA section 6 final risk evaluation 
that provides a final toxicity value on a PFAS would constitute a 
triggering event for the PFAS covered by that toxicity value. TSCA 
requires that risk evaluations conducted by EPA ``integrate and assess 
available information on hazards.'' 15 U.S.C. 2605(b)(4)(F)(i). 
Accordingly, in a risk evaluation, EPA identifies the adverse health or 
environmental effects caused by exposure to the subject chemical. 
Hazards may include, but are not limited to, toxicity with respect to 
cancer, mutation, reproductive, developmental, respiratory, immune, 
cardiovascular impacts, and neurological impairments, and a point of 
departure (POD) or cancer risk is calculated. A final risk evaluation, 
thus, provides toxicity values for a chemical. Publication of a final 
risk evaluation on a PFAS would cause that PFAS if not already on the 
TRI list to be added to the TRI list pursuant to NDAA 7321(c)(1)(A)(1).
    <bullet> EPA derives toxicity values to support regulatory and non-
regulatory activities under the Safe Drinking Water Act and Clean Water 
Act. The EPA's Water Program develops human health assessments called 
Toxicity Assessments or Health Effects Support Documents (HESDs), that 
identify and characterize health effects information on chemicals that 
are known or likely to be found in water, including derivation of 
toxicity values and determination of cancer descriptors when cancer 
information is available. The publication of a final assessment that 
provides a toxicity value for a PFAS would constitute a triggering 
event. EPA develops human health assessments to support rules or 
drinking water and other health advisories. These assessments are 
called Toxicity Assessments or Health Effects Support Documents (HESDs) 
and they identify and characterize health effects information on 
chemicals that are known or likely to be found in water. They also 
include derivations of toxicity values and determinations of cancer 
descriptors when cancer information is available. These documents 
provide the underlying RfD or, if applicable, the cancer risk values 
for drinking water contaminants that support the associated Health 
Advisory. A final HESD, thus, provides a toxicity value for a chemical. 
Publication of a final HESD on a PFAS would cause that PFAS if not 
already on the TRI list to be added to the TRI list pursuant to NDAA 
7321(c)(1)(A)(1).
    <bullet> Other toxicity values that EPA's offices finalize. For 
example, in addition to the IRIS program and PPRTV assessments noted 
previously, ORD publishes other toxicity assessments that include 
toxicity values. Publication of a final toxicity assessment that 
provides a toxicity value for one or more PFAS would constitute a 
triggering action for those PFAS.
    Whenever one of the triggering actions identified here is taken for 
a PFAS that is not on the TRI list, then, as provided by NDAA section 
7321(c), such a PFAS would be added to the TRI list with an effective 
date of January 1 of the following calendar year.
    EPA is proposing to explain what Agency events constitute 
finalization of a toxicity value for a PFAS or class of PFAS to ensure 
consistent implementation of the statutory provision (i.e., NDAA 
section 7321(c)). The Agency recognizes that Congress did not limit the 
term ``toxicity value'' to values finalized by any particular program 
such as EPA's IRIS program or to values finalized by any specific EPA 
office, but instead used broad language referring to ``a toxicity value 
for the perfluoroalkyl or polyfluoroalkyl substance or class of 
perfluoroalkyl or polyfluoroalkyl substances'' finalized by the 
Administrator. This statutory language covers actions ``by the 
Administrator'' to finalize toxicity

[[Page 81803]]

values. By referencing actions taken ``by the Administrator'' instead 
of specifying actions taken by a particular EPA office, division or 
program, Congress provided that values finalized by any Agency office, 
division or program may trigger TRI listing. For purposes of TRI 
listing, it does not matter which Agency program finalizes the toxicity 
value. Moreover, recognizing that NDAA section 7321(c) covers toxicity 
values finalized by multiple types of Agency actions and programs is 
consistent with the purpose of EPCRA section 313 as described by 
Congress in paragraph (h) (i.e., to provide information to the public 
and governmental entities; to assist in the conduct of research and 
data gathering; to aid in the development of appropriate regulations, 
guidelines, and standards; and for other similar purposes). Ensuring 
that TRI data on PFAS are available may be helpful to inform the public 
and also, may assist EPA programs to assess risk by using the TRI 
exposure information. Further, as the NDAA did not define ``finalize a 
toxicity value'' nor limit the scope to only certain EPA programs or 
authorities involving toxicity values, the Agency concludes it is 
reasonable to interpret this provision as applying to multiple Agency 
actions, as defined previously.
    Further, the NDAA did not expand on the meaning of ``finalize''. In 
the absence of a congressional definition, EPA assumes Congress 
intended to use the plain meaning of the term ``finalize.'' Merriam-
Webster's online dictionary's (https://www.merriam-webster.com) first 
definition of ``finalize'' is ``to put in final or finished form'' (see 
also Webster's Third New International Dictionary of the English 
Language 851 (1993)) but there is no universally recognized 
understanding of what that means in this context. In the context of the 
section 7321 of the NDAA, the Agency proposes to conclude this means to 
produce a toxicity value for a chemical following established Agency 
regulations, guidance, protocol, or procedure(s). The process for 
finalizing a toxicity value might differ slightly depending on the 
unique needs or evaluations performed by individual EPA offices or 
programs; however, as previously explained, each triggering event 
described in this proposal results in the analysis and establishment of 
a value at which adverse effects of a substance may occur or a value at 
which adverse effects of a substance are not anticipated to occur. EPA 
has determined that its interpretation is consistent with historical 
application of the word ``final' or ``finalizes'', as well as the 
intent of the Sec. 7321 of the NDAA to ``improve transparency by 
requiring emitters to report to the EPA the release of any of one of 
hundreds of PFAS compounds into the environment''. (165 Cong. Rec. 
S4531-01 (June 26, 2019) (statement of Sen. Shelley Capito)).
    EPA proposes to conclude that when EPA publishes or issues one of 
the document types identified above, including when it takes final 
action to update or revise such a document, and that document includes 
a toxicity value for a PFAS, the Agency is at that time `finalizing a 
toxicity value' as that term is used in the 2020 NDAA. This approach 
recognizes that each of the document types described above, when 
published or issued, include EPA's final assessment of hazard 
information regarding a particular chemical substance.
    This reading is consistent with the approach taken by Congress in 
paragraph (b) of section 7321 of the NDAA. Paragraph (b) identifies 
specific PFAS that are added to TRI beginning January 1 of the calendar 
year following enactment of the 2020 NDAA. The chemical substances that 
Congress identified for immediate inclusion on TRI included chemicals 
for which EPA was, at the time of the NDAA's passage, undertaking 
toxicity assessments to derive related toxicity values beyond the IRIS 
program. For example, EPA published for public comment draft drinking 
water Human Health Toxicity Values for GenX chemicals in 2018 (Ref. 74) 
and released a final Health Effects Support Document for PFOS in 2016 
(Ref. 75). At the time of the NDAA's enactment, Congress immediately 
added PFAS (GenX and PFOS) for which only non-IRIS toxicity values were 
either published or under review. Further, the IRIS assessments and the 
documents published or issued by other EPA programs identified above as 
events which would trigger addition of the PFAS or class of PFAS to TRI 
under NDAA section 7321(c), due to their finalizing toxicity values for 
PFAS, all contain rigorous evaluations of data to support finalization 
of a toxicity value. The scientific rigor of these documents is 
consistent with the rigor of scientific literature used for chemical 
listings pursuant to EPCRA section 313(d)(2). In other words, each of 
the above listed EPA triggering events aligns with publications that 
the Agency would use to support a TRI listing. Congress, in providing 
paragraph 7321(c)(1)(A)(i) of the NDAA, created a mechanism that would 
alleviate EPA from conducting an EPCRA section 313(d)(2) rulemaking to 
list chemicals for which the Agency had developed support for a TRI 
listing. And, thus, this provision fast tracks the addition of such 
chemicals to assist in the collection of TRI data to further the 
statute's purposes.
    For purposes of which chemicals constitute ``PFAS'' pursuant to 
triggering events provided in NDAA section 7321(c), EPA considers any 
chemical to be a PFAS if it is determined to be a PFAS by the 
applicable EPA action. EPA anticipates that most EPA activities that 
trigger additions of PFAS to TRI will determine the chemical to be PFAS 
as part of the action, thereby obviating the need to apply a specific 
definition to determine whether the chemical is a PFAS for purposes of 
NDAA section 7321(c). As explained in Unit II.A., this approach of 
treating chemicals as PFAS if they are determined to be PFAS by the 
applicable triggering EPA event supports the scope of TRI, helping to 
ensure that data on PFAS is available to help support informed 
decision-making by companies, government agencies, non-governmental 
organizations, and the public.
    For example, 1,1,1-Trifluoro-N-[(trifluoromethyl)sulfonyl] 
methanesulfonamide (TFSI) is not a PFAS per the definition being used 
for purposes of identifying PFAS candidates for this rulemaking. 
However, EPA published a final human health toxicity value for TFSI in 
July 2023 that also applies to the related salt (e.g., lithium 
bis[(trifluoromethyl)sulfonyl]azanide (HQ-115) (CASRN 90076-65-6). 
Accordingly, this chemical, due to it being labeled a PFAS by the 
published document, is on the TRI list with an effective date of 
January 1, 2024. Pursuant to the proposed CFR text for implementing the 
automatic addition of PFAS process provided by NDAA section 7321(c), if 
finalized, TFSI would be added to the TRI list as a chemical category 
that includes TFSI and any associated salts (note that acyl/sulfonyl 
halides and anhydrides would not be relevant to this category).

VIII. Request for Comment

    In this document, EPA is providing an opportunity for public 
comment on the actions proposed herein and the rationale for those 
proposed actions. EPA is also specifically requesting public comment on 
the following topics:
    1. EPA seeks comment on its category approach for listing and 
grouping PFAS for TRI reporting purposes (i.e., Acid, Associated Salts, 
Acyl/Sulfonyl Halides, and Anhydride). Specifically, EPA solicits 
comment on the Agency's proposed chemical categories and

[[Page 81804]]

whether they should include any or all such compounds related to the 
acid (that is, salts, acyl/sulfonyl halides, and anhydrides), or to 
keep such additional, related listings separate as individual listings. 
For instance, the Agency is requesting comment on the examples the 
Agency is proposing to list in this rule as additions based on their 
inclusion in their respective categories: perfluorobutanoyl fluoride 
(CASRN 335-42-2) based on perfluorobutanoic acid (PFBA) (CASRN 375-22-
4), 3,3,4,4,5,5,6,6,7,7,8,8,8-, tridecafluorooctanesulphonyl chloride 
(CASRN 27619-89-2) based on 1H,1H, 2H, 2H-perfluorooctane sulfonic acid 
(6:2 FTS) (CASRN 27619-97-2), and pentafluoropropanoic anhydride (CASRN 
356-42-3) based on perfluoropropanoic acid (PFPrA) (CASRN 422-64-0).
    2. Additionally, in the event that EPA uses a category approach for 
TRI PFAS reporting, the Agency is considering whether to expand the 
categories (e.g., to include additional chemicals related to the acid 
on which a given category is based, beyond the previously mentioned 
salts, acyl/sulfonyl halides, and anhydrides), along with data 
supporting such a listing under EPCRA 313.
    3. In this document, EPA has defined category names based on the 
composition of the categories with the most inclusive identified 
members. EPA requests comment on whether all category names should 
refer to salts, acyl/sulfonyl halides, and/or anhydrides related to the 
acid for which the category is named, or only include salts, acyl/
sulfonyl halides, and/or anhydrides where that category specifically 
identifies such examples as part of the category's composition. For 
example, the 9Cl-PF3ONS (Unit III.B.1.) and 11Cl-PF3OUdS (Unit 
III.B.2.) category names, as proposed, are inclusive of potential 
sulfonyl halides and anhydrides because these chemicals could exist 
from a chemistry standpoint, but the Agency is unaware of such 
chemicals being used in commerce. By including potential sulfonyl 
halides and anhydrides in the category name, if a facility did 
manufacture, process, or otherwise use such chemicals and triggered TRI 
reporting requirements for its dealings with those chemicals, then 
reporting on such chemicals would be part of its reporting on the 
associated category, along with its dealings with other chemicals in 
the given category. Naming the categories to be inclusive of acyl/
sulfonyl halides and anhydrides will leave room for later addition into 
the category.
    4. EPA welcomes comment on the proposed reporting approach to such 
categories that, if finalized, would require facilities to calculate 
thresholds and report the aggregated weights of release and other 
wastes from all constituents of a PFAS category. This proposed approach 
is an alternative to a requirement to report the weights of just the 
parent acid, ion, or other moiety of concern of all chemicals in that 
category for release and other waste management reporting (such as, for 
example, the release reporting requirements of metal compound 
categories or water-dissociable nitrate compounds).
    5. EPA seeks comment on whether any of the PFAS being proposed as 
individual listings should be listed as categories instead (i.e., are 
any of the proposed individual listings anticipated to have salts, 
acyl/sulfonyl halides, an anhydride, or other related substances for 
which toxicity concerns would be anticipated to be similar to the 
proposed individually listed chemical?). EPA notes that categories 
could be formed for an amide and related chemicals (e.g., salts), 
rather than listing them as individual chemicals, and specifically 
solicits comment on whether to list PFAS amides as categories similar 
to the categories including the carboxylic/sulfonic PFAS acids and 
their salts.
    6. EPA seeks comment on whether or not all the proposed categories 
should include acyl/sulfonyl halides and anhydrides. EPA has included 
them where known, but there may be some missing, or the Agency may 
become aware of an acyl/sulfonyl halide or anhydride in the future.
    7. EPA seeks comment on the approach of listing a PFAS acid based 
on its salt. Where hazard data sufficient to support a listing were 
available for a PFAS salt but not the corresponding non-salt PFAS acid, 
the Agency could list the PFAS acid based on the toxicity of the salt. 
This assumes the compound comprising the salt does not contribute its 
own toxicity separate from the PFAS portion of the chemical. For 
example, perfluoro(2-ethoxy-2-fluoroethoxy)acetic acid ammonium salt 
(EEA-NH4; CASRN 908020-52-0) is individually being proposed for 
listing. Perfluoro-3,6-dioxaoctanoic acid (CASRN 80153-82-8) is the 
corresponding PFAS acid, with an expected similar toxicity to the 
ammonium salt (negligible toxicity expected to be contributed by the 
NH4+ in the ammonium salt). Note that this also relates to Unit VIII. 
about PFAS amides and related substances as categories.
    8. EPA seeks comment on whether there are PFAS beyond the chemicals 
identified in this proposal for which available data would be 
sufficient for a TRI listing. EPA solicits comment on PFAS that the 
Agency might have overlooked where existing hazard literature would 
support a finding required by EPCRA 313(d)(2) for a TRI chemical 
listing, including on the basis of its expected degradants. Examples of 
such chemicals include those PFAS specified by the NDAA section 
7321(d)(A) through (N), but for which EPA did not find sufficient 
information supporting a listing pursuant to EPCRA 313(d)(2) criteria 
which include 8:2 fluorotelomer sulfonic acid (8:2 FTS) (CASRN 39108-
34-4) and N-ethyl perfluorooctanesulfonamidoacetic acid (NEtFOSAA) 
(CASRN 2991-50-6).
    For any PFAS that is not included in this proposed rule but which 
commenters support listing, EPA requests any supporting data of 
sufficient quality to support an EPCRA 313 listing. In submitting 
literature for EPA's consideration, please refer to previous TRI 
chemical listing rule discussions for further guidance on how the 
Agency determines whether a study or data is sufficient for TRI 
listing, and whether there is sufficient data support an EPCRA 313 
listing: see the Addition of 12 Chemicals final rule (87 FR 73475; 
November 30, 2022 (Ref. 16)) and the 1994 chemical list expansion final 
rule (59 FR 61432; November 30, 1994 (Ref. 11)).
    EPA is not proposing to list any chemicals based on their being 
known to cause or their being reasonably anticipated to cause 
significant adverse acute human health effects at concentration levels 
that are reasonably likely to exist beyond facility site boundaries as 
a result of continuous, or frequently recurring, releases (42 U.S.C. 
11023(d)(2)(A)). Where EPA noted acute human health effects for a given 
chemical, the Agency also concluded that a serious or irreversible 
adverse chronic human health effect or significant adverse effect on 
the environment of sufficient seriousness existed to support the 
listing of that chemical. Accordingly, EPA focused on the chronic human 
health effect and/or effect on the environment in lieu of addressing 
the ``beyond facility site boundaries'' requirement in a listing based 
on a significant adverse acute human health effect. EPA is soliciting 
comment on any PFAS that is not on the TRI list and that this proposed 
rule has not included as a candidate that might be added to the TRI 
list based on a significant adverse acute human health effect. 
Additionally, information related to possible exposure to the chemical 
beyond facility site boundaries is also being requested.

[[Page 81805]]

    9. EPA seeks comment on its approach using ECOTOX and EPA HAWC 
projects (and information summarized by other EPA databases in general) 
for the purpose of supporting chemical listings on TRI (see fulvestrant 
(CASRN: 129453-61-8) and (1H,1H, 2H, 2H-perfluorooctane sulfonic acid 
(6:2 FTS) (CASRN 27619-97-2)). EPA also solicits comment on whether 
other methods of providing evidence to support TRI chemical listings 
other than listing support documents specifically drafted for the TRI 
action may be appropriate, such as read-across methods (i.e., applying 
hazard data from a data-rich source chemical to a related data-poor 
chemical to determine potential properties or hazards).
    10. EPA seeks comment on the 100-pound reporting threshold being 
proposed for the listing in this rulemaking. Additionally, EPA seeks 
comment on whether the threshold used for these proposed additions to 
the TRI list should be aligned with the threshold applicable to PFAS 
added pursuant to NDAA section 7321(b) and (c).
    11. EPA seeks comment on its proposed regulatory framework for 
establishing PFAS categories encompassing the salts and acyl/sulfonyl 
halides of future PFAS acids that will be automatically added to the 
TRI list after a triggering event pursuant to NDAA section 7321(c).
    12. EPA requests comment on what nomenclature to use for these 
categories (e.g., ``[acid name], salts and acyl/sulfonyl halides'', 
``[acid name], salts, acyl/sulfonyl halides, and the anhydride form'', 
``[acid name] and associated compounds'', or some other convention). 
For the ``associated compounds'' nomenclature, EPA would define or 
interpret ``associated compounds'' to refer to salts, acyl/sulfonyl 
halides, and/or anhydrides.
    In addition to the requests for comment described in this document, 
EPA also requests comment on the additional topics identified in this 
document to help inform potential future TRI regulatory activities.
    13. Since PFAS are ubiquitous in the environment and robust hazard 
data exist for well-studied PFAS (Ref. 3, 14, 70), EPA is considering 
additional avenues to expedite adding PFAS to the TRI list. For 
example, the OECD has described a standardized terminology for defining 
PFAS and grouping them based on their structural traits (Ref. 7). EPA 
has developed Markush representations to group and categorize PFAS 
based on generalized structures (see https://comptox.epa.gov/dashboard/chemical-lists/PFASMARKUSH). EPA has also developed PFAS-specific 
structural representations known as ToxPrints to characterize PFAS by 
their atom, bond, chain, and functional group to facilitate category 
development (Ref. 76). More broadly, OECD has published technical 
guidance for the development, justification and application of category 
and analogue approaches. These analogue and category approaches are 
typically underpinned by one or more of the following similarity 
contexts including structural, physicochemical, metabolic, bioactivity, 
reactivity and (eco)toxicological similarity. While no single 
categorization approach will satisfy all needs and the specifics of a 
given category approach will likely differ depending on the intended 
application, such grouping approaches are well-established in the 
scientific literature and are widely applied within the scientific and 
regulatory community (Ref. 7). These approaches typically categorize 
PFAS based on foundational understandings of chemistry and toxicity. To 
this end, EPA is requesting comment on whether the Agency should 
identify PFAS for which there is a lack of direct evidence to support a 
TRI listing, but instead base the listing on similarities (e.g., 
structural similarities) a particular PFAS shares with other PFAS for 
which there is sufficient evidence, and apply such evidence to the 
data-poor PFAS. For example, EPA is proposing to add 6:2 fluorotelomer 
alcohol, 6:2 fluorotelomer sulfonamide betaine, 6:2 fluorotelomer 
sulfonate ammonium, and 8:2 fluorotelomer sulfonic acid to the TRI list 
based on available data. It is also aware of other similar chemical 
substances such as 3:1 fluorotelomer alcohol, and 4:2 fluorotelomer 
alcohol. While EPA may not have hazard data specific on these 
chemicals, it could determine that these listings are appropriate based 
on generally accepted scientific principles. In this example, data on 
the chemicals being proposed for listing could be used as sufficient 
evidence to demonstrate that these other, similar chemicals (i.e., 3:1 
fluorotelomer alcohol and 4:2 fluorotelomer alcohol) also meet the 
criteria for listing on the TRI. EPA posits that X:2 and X:1 
fluorotelomer alcohols and their precursors and derivatives, which are 
expected to break down into the corresponding X-length fluoroalkyl 
carboxylates, are expected to result in similar adverse effects on 
human health and the environment as substances already TRI-listed as 
well as those being proposed for addition to the TRI. EPA is 
considering the appropriateness of this general approach, as well as 
means to further speciate its application, for these as well as other 
categories as described by OECD and other regulatory bodies, including 
EPA. EPA is soliciting comment on this approach, as well as requesting 
assistance in identifying additional chemicals to consider based on 
such an approach.
    14. Pursuant to the NDAA, for PFAS added to the TRI list pursuant 
to NDAA section 7321(b) and (c), EPA must, within five years after the 
NDAA's enactment, determine whether it is warranted to revise the 100-
pound reporting threshold provided by the NDAA for chemicals added to 
the TRI pursuant to those paragraphs. Accordingly, EPA seeks comment on 
its proposal to implement a 100-pound reporting threshold for PFAS 
added to the TRI list pursuant to NDAA section 7321(b) and (c). 
Similarly, EPA seeks comment on the 100-pound reporting threshold being 
proposed for the listing in this rulemaking. Further, EPA is soliciting 
comment on whether the reporting threshold should be consistent across 
all PFAS on the TRI list, regardless of the specific mechanism that 
caused their addition to the TRI list.
    15. EPA seeks comment on whether documents related to EPA actions 
other than those specified in Unit VII. should be identified as events 
that the Agency interprets as ``finaliz[ing] a toxicity value'' as that 
term is used in NDAA section 7321(c)(1)(A)(1).
    16. The Agency is soliciting comment on the listing support 
documents specifically prepared for this action and whether they 
justify its proposed determination that there is sufficient evidence to 
establish that one or more of the criteria for listing under EPCRA 
section 313(d)(2) have been met.

IX. 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 itself physically located in the 
docket. For assistance in locating these other documents, please 
consult the person listed under FOR FURTHER INFORMATION CONTACT.

1. U.S. Environmental Protection Agency (September 2024). Economic 
Analysis for the Addition of Certain Per- and Polyfluoroalkyl 
Substances; Community Right-to-Know Toxic Chemical Release 
Reporting; Proposed Rule (RIN 2070-AL03).
2. U.S. Environmental Protection Agency (2023). TSCA Section 8(a)(7) 
Reporting and Recordkeeping Requirements for

[[Page 81806]]

Perfluoroalkyl and Polyfluoroalkyl Substances; Final Rule. 88 FR 
70516 (October 11, 2023 (FRL-7902-02-OCSPP)). https://www.govinfo.gov/content/pkg/FR-2023-10-11/pdf/2023-22094.pdf
3. U.S. Environmental Protection Agency. Our current understanding 
of the human health and environmental risks of PFAS. 2022. https://www.epa.gov/pfas/our-current-understanding-human-health-and-environmental-risks-pfas
4. Agency for Toxic Substances and Disease Registry (2021). 
Toxicological Profile for Perfluoroalkyls. U.S. Department of Health 
and Human Services. https://www.atsdr.cdc.gov/toxprofiles/tp200.pdf
5. Agency for Toxic Substances and Disease Registry. Per- and 
Polyfluoroalkyl Substances (PFAS) and Your Health. PFAS in the U.S. 
Population. June 2023. https://www.atsdr.cdc.gov/pfas/health-effects/us-population.html
6. Centers for Disease Control and Prevention (2015). Fourth 
National Report on Human Exposure to Environmental Chemicals. 
Department of Health and Human Services. https://www.cdc.gov/biomonitoring/pdf/fourthreport_updatedtables_feb2015.pdf
7. Organisation for Economic Co-Operation and Development (2021). 
Reconciling Terminology of the Universe of Per- and Polyfluoroalkyl 
Substances: Recommendations and Practical Guidance. Series on Risk 
Management. No.61. Environment Directorate Chemicals and 
Biotechnology Committee. https://one.oecd.org/document/ENV/CBC/MONO(2021)25/en/pdf
8. Buck, R.C., et al. (2021). Identification and Classification of 
Commercially Relevant Per- and Poly Fluoroalkyl Substances (PFAS). 
Integrated Environmental Assessment and Management 17(5):p. 1045-
1055. https://doi.org/10.1002/ieam.4450
9. U.S. Environmental Protection Agency. CompTox Chemicals 
Dashboard. 2021. https://comptox.epa.gov/dashboard/
10. U.S. Environmental Protection Agency. EPA PFAS chemicals without 
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https://comptox.epa.gov/dashboard/chemical-lists/PFASDEV1
11. U.S. Environmental Protection Agency (1994). Addition of Certain 
Chemicals; Toxic Chemical Release Reporting; Community Right-to-
Know; Final Rule. 59 FR 61432 (November 30, 1994 (FRL-4922-2)).
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September 2023. https://cfpub.epa.gov/ecotox/
13. U.S. Environmental Protection Agency. EPA Health Assessment 
Workspace Collaborative (EPA HAWC): ORD SEM PFAS 150. 2022. https://hawc.epa.gov/assessment/100500085/
14. Carlson, L.M., et al. (2022). Systematic Evidence Map for Over 
One Hundred and Fifty Per- and Polyfluoroalkyl Substances (PFAS). 
Environmental Health Perspectives 130(5):p. 056001. https://doi.org/10.1289/EHP10343
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16. U.S. Environmental Protection Agency (2022). Addition of Certain 
Chemicals; Community Right-to-Know Toxic Chemical Release Reporting. 
87 FR 73475 (November 30, 2022 (FRL-5927-02-OCSPP)).
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Reaction Library Version 1.1: Hydrolysis Schemes. July 2022. https://qed.epa.gov/static_qed/cts_app/docs/PFAS%20HTML/PFASEnvironmentalReactionLibrary_ver1-1.htm#EnvLib_Scheme_6
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TRI Listing Support Document for 9-Chlorohexadecafluoro-3-oxanone-1-
sulfonic acid (9Cl-PF3ONS) (CASRN 756426-58-1).
21. U.S. Environmental Protection Agency (2023). Ecological Hazard 
TRI Listing Support Document for 9-Chlorohexadecafluoro-3-oxanone-1-
sulfonic acid (9Cl-PF3ONS) (CASRN 756426-58-1).
22. U.S. Environmental Protection Agency (2023). Ecological Hazard 
TRI Listing Support Document for 11-Chloroeicosafluoro-3-
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24. U.S. Environmental Protection Agency (2021). Human Health 
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and Related Compound Potassium Perfluorobutane Sulfonate (CASRN 
29420-49-3). Office of Research and Development, Center for Public 
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Review of Perfluorobutanoic Acid (PFBA, CASRN 375- 22-4) and Related 
Salts. Office of Research and Development, Center for Public Health 
and Environmental Assessment. EPA/600/R-20/345F. https://iris.epa.gov/ChemicalLanding/&substance_nmbr=701
26. U.S. Environmental Protection Agency (2024). IRIS Toxicological 
Review of Perfluorodecanoic Acid (PFDA) and Related Salts. Office of 
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Assessment. https://ordspub.epa.gov/ords/eims/eimscomm.getfile?p_download_id=549465
27. World Health Organization & International Programme on Chemical 
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Assessment and Translation. https://ntp.niehs.nih.gov/ntp/ohat/pfoa_pfos/pfoa_pfosmonograph_508.pdf
29. U.S. Environmental Protection Agency (2022). Review of EPA's 
analyses to support EPA's national primary drinking water rulemaking 
for PFAS (EPA-SAB-22-008). https://sab.epa.gov/ords/sab/f?p=100:18:16490947993:::18:P18_ID:2601
30. U.S. Environmental Protection Agency (2023). Human Health Hazard 
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31. U.S. Environmental Protection Agency (2023). IRIS Toxicological 
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https://iris.epa.gov/ChemicalLanding/&substance_nmbr=705
32. U.S. Environmental Protection Agency (2023). IRIS Toxicological 
Review of Perfluorohexanoic Acid [PFHxA, CASRN 307-24-4] and Related 
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33. U.S. Environmental Protection Agency (2023). PFAS National 
Primary Drinking Water Regulation; Final Rule. 89 FR 32532 (April 
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Review of Perfluorononanoic Acid (PFNA) and Related Salts (CASRN 
375-95-1) (External Review Draft). Office of Research and 
Development, Center for Public Health and Environmental Assessment. 
EPA/635/R-24/031a. https://ordspub.epa.gov/ords/eims/

[[Page 81807]]

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Rule. 64 FR

[[Page 81808]]

58666 (October 29, 1999 (FRL-6389-11)). https://www.govinfo.gov/content/pkg/FR-1999-10-29/pdf/99-28169.pdf
68. U.S. Environmental Protection Agency (2023). Changes to 
Reporting Requirements for Per- and Polyfluoroalkyl Substances and 
to Supplier Notifications for Chemicals of Special Concern; 
Community Right-to-Know Toxic Chemical Release Reporting; Final 
Rule. 88 FR 74360 (October 31, 2023 (FRL-8742-04-OCSPP)). https://www.govinfo.gov/content/pkg/FR-2023-10-31/pdf/2023-23413.pdf
69. U.S. Environmental Protection Agency. PFAS explained. 2022. 
https://www.epa.gov/pfas/pfas-explained
70. Kotthoff, M., et al. (2015). Perfluoroalkyl and polyfluoroalkyl 
substances in consumer products. Environmental Science and Pollution 
Research. Environmental Science and Pollution Research 22(19):p. 
14546-14559. https://doi.org/10.1007/s11356-015-4202-7
71. U.S. Environmental Protection Agency (1994). Alternate Threshold 
for Facilities with Low Annual Reportable Amounts; Toxic Chemical 
Release Reporting; Community Right-To-Know; Final Rule. 59 FR 61488 
(November 30, 1994 (FRL-4920-5)). https://archives.federalregister.gov/issue_slice/1994/11/30/61429-61502.pdf
72. California Department of Toxic Substances Control. DTSC Toxicity 
Criteria Rule for Human Health Risk Assessments, Responses to 
Frequently Asked Questions (FAQs). 2024. https://dtsc.ca.gov/toxicity-criteria-rule-for-human-health-risk-assessments-faq/
73. U.S. Environmental Protection Agency (2013). Tier 3 Toxicity 
Value White Paper. Regional Tier 3 Toxicity Value Workgroup. OSWER 
Human Health Regional Risk Assessors Forum. https://nepis.epa.gov/Exe/ZyPDF.cgi/P100NTU6.PDF?Dockey=P100NTU6.PDF
74. U.S. Environmental Protection Agency (2018). Human Health 
Toxicity Values for Hexafluoropropylene Oxide (HFPO) Dimer Acid and 
Its Ammonium Salt (CASRN 13252-13-6 and CASRN 62037-80-3), Also 
Known as ``GenX Chemicals'' (Public Comment Draft). Office of Water. 
EPA-823-P-18-001. https://www.epa.gov/sites/default/files/2018-11/documents/genx_public_comment_draft_toxicity_assessment_nov2018-508.pdf
75. U.S. Environmental Protection Agency (2016). Health Effects 
Support Document for Perfluorooctane Sulfonate (PFOS). Office of 
Water. EPA 822-R-16-002. https://www.epa.gov/sites/default/files/2016-05/documents/pfos_hesd_final_508.pdf
76. Richard, A.M., et al. (2023). A New CSRML Structure-Based 
Fingerprint Method for Profiling and Categorizing Per- and 
Polyfluoroalkyl Substances (PFAS). Chemical Research in Toxicology 
36(3):p. 508-534. https://doi.org/10.1021/acs.chemrestox.2c00403
77. U.S. Environmental Protection Agency (2024). Rule-Related ICR; 
Addition of Certain Per- and Polyfluoroalkyl Substances; Toxic 
Chemical Release; Proposed Rule (RIN 2070-AL03). EPA ICR No. 
2796.01, OMB Control No. 2070-NEW.

X. What are the Statutory and Executive Orders reviews associated with 
this action?

    Additional information about these statutes and Executive Orders 
can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and 14094: 
Modernizing Regulatory Review

    This action is a ``significant regulatory action'' as defined in 
Executive Order 12866 (58 FR 51735, October 4, 1993), as amended by 
Executive Order 14094 (88 FR 21879, April 11, 2023). Accordingly, EPA 
submitted this action to the Office of Management and Budget (OMB) for 
Executive Order 12866 review. Documentation of any changes made in 
response to the Executive Order 12866 review is available in the 
docket. EPA prepared an economic analysis of the potential impacts 
associated with this action. This analysis, ``Economic Analysis'' (Ref. 
1) is also available in the docket and summarized in Unit I.D.

B. Paperwork Reduction Act (PRA)

    The information collection activities in this proposed rule have 
been submitted for approval to OMB under the PRA, 44 U.S.C. 3501 et 
seq. The Information Collection Request (ICR) document that EPA 
prepared has been assigned EPA ICR No. 2796.01 and OMB Control No. 
2070-NEW (Ref. 77). You can find a copy of the ICR in the docket, and 
it is briefly summarized here.
    Facilities subject to the reporting requirements under EPCRA 
section 313 and PPA section 6607 may use either EPA Toxic Chemicals 
Release Inventory Form R (EPA Form 9350-1), or EPA Toxic Chemicals 
Release Inventory Form A (EPA Form 9350- 2). The Form R must be 
completed if a facility manufactures, processes, or otherwise uses any 
listed chemical above threshold quantities and meets certain other 
criteria. For the Form A, EPA established an alternative threshold for 
facilities with low annual reportable amounts of a listed toxic 
chemical. A facility that meets the appropriate reporting thresholds, 
but estimates that the total annual reportable amount of the chemical 
does not exceed 500 pounds per year, can take advantage of an 
alternative manufacture, process, or otherwise use threshold of 1 
million pounds per year of the chemical, provided that certain 
conditions are met, and submit the Form A instead of the Form R. In 
addition, respondents may designate the specific chemical identity of a 
substance as a trade secret pursuant to EPCRA section 322, 42 U.S.C. 
11042, 40 CFR part 350.
    Respondents/affected entities: Facilities covered under EPCRA 
section 313 that manufacture, process or otherwise use listed PFAS see 
Unit I.A.
    Respondent's obligation to respond: Mandatory per EPCRA 313.
    Estimated number of respondents: 356 to 1,110.
    Frequency of response: annually.
    Total estimated burden: 26,693 to 83,229 burden hours in the first 
year and approximately 12,711 to 39,633 burden hours in the steady 
state (per year). Burden is defined at 5 CFR 1320.3(b).
    Total estimated cost: Approximately $2,114,886 to $6,594,234 in the 
first year of the reporting and approximately $1,007,093 to $3,140,123 
includes $0 annualized capital or operation and maintenance costs.
    An agency may not conduct or sponsor, and a person is not required 
to respond to, a collection of information unless it displays a 
currently valid OMB control number. The OMB control numbers for EPA's 
regulations in 40 CFR are listed in 40 CFR part 9.
    Submit your comments on the Agency's need for this information, the 
accuracy of the provided burden estimates and any suggested methods for 
minimizing respondent burden to EPA using the docket identified at the 
beginning of this rule. EPA will respond to any ICR-related comments in 
the final rule. You may also send your ICR-related comments to OMB's 
Office of Information and Regulatory Affairs using the interface at 
https://www.reginfo.gov/public/do/PRAMain. Find this particular ICR by 
selecting ``Currently under Review--Open for Public Comments'' or by 
using the search function. OMB must receive comments no later than 
November 7, 2024.

C. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic 
impact on a substantial number of small entities under the RFA, 5 
U.S.C. 601 et seq. The small entities subject to the requirements of 
this action are small manufacturing facilities. The Agency has 
determined that of the 356 to 1,110 entities estimated to be impacted 
by this action, 277 to 865 are small businesses; no small governments 
or small organizations are expected to be affected by this action. The 
average cost per small firm is $6,338 (at a 2% discount rate). All 
small businesses affected by

[[Page 81809]]

this action are estimated to incur annualized cost impacts of less than 
1%. Even under a worst-case scenario comparing compliance costs to 
average revenue of firms with between 10 (smallest number required to 
report) and 14 employees instead of comparing compliance costs to the 
weighted average revenue of small firms, there are still no costs that 
exceed the 1% impact threshold. Thus, this action is not expected to 
have a significant adverse economic impact on a substantial number of 
small entities. A more detailed analysis of the impacts on small 
entities is provided in EPA's economic analysis (Ref. 1).

D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain an unfunded mandate of $100 million or 
more as described in UMRA, 2 U.S.C. 1531-1538, and does not 
significantly or uniquely affect small governments. As indicated 
previously, EPA estimates the costs of this action will be 
approximately $2,114,886 and $6,594,234 in the first year of reporting 
and approximately $1,007,093 and $3,140,123 in the subsequent years 
(Ref. 1).

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. It does not have substantial direct 
effects on tribal government because this action relates to toxic 
chemical reporting under EPCRA section 313, which primarily affects 
private sector facilities. 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 (62 FR 19885, April 23, 1997) 
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 Executive Order 13045.
    Since this is not a ``covered regulatory action,'' E.O. 13045 does 
not apply. However, the Policy on Children's Health does apply. 
Although this action does not concern an environmental health or safety 
risk, the data collected as a result of this action will provide 
information about releases to the environment that could be used to 
inform the public on potential exposures to toxic chemical releases, 
pursuant to the right-to-know principles. EPA also believes that the 
information obtained as a result of this action could be used by 
government agencies, researchers, and others to identify potential 
problems, set priorities, and take appropriate steps to reduce any 
potential exposures and related human health or environmental risks 
identified as a result of increased knowledge of exposures to PFAS.

H. National Technology Transfer and Advancement Act (NTTAA)

    This action does not involve technical standards under the NTTAA 
section 12(d), 15 U.S.C. 272.

I. Executive Order 12898: Federal Actions To Address Environmental 
Justice in Minority Populations and Low-Income Populations and 
Executive Order 14096: Revitalizing Our Nation's Commitment to 
Environmental Justice for All

    EPA believes that this type of action does not directly impact 
human health or environmental conditions. Although this action does not 
directly impact human health or environmental conditions, EPA 
identifies and addresses environmental justice concerns in accordance 
with Executive Orders 12898 (59 FR 7629, February 16, 1994) and 14096 
(88 FR 25251, April 26, 2023) by requiring reporting. This regulatory 
action makes changes to the reporting requirements for PFAS that will 
result in more information being collected and provided to the public. 
By requiring reporting of this additional information, EPA provides 
communities across the U.S. (including communities with environmental 
justice concerns) with access to data which they may then use to seek 
lower exposures and consequently reduce chemical risks for themselves 
and their children. This information can also be used by government 
agencies and others to identify potential problems, set priorities, and 
take appropriate steps to reduce any potential risks to human health 
and the environment. Therefore, the informational benefits of the 
action will have a positive impact on the human health and 
environmental impacts on communities with environmental justice 
concerns.

J. 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.

List of Subjects in 40 CFR Part 372

    Environmental protection, Community right-to-know, Reporting and 
recordkeeping requirements, and Toxic chemicals.

    Dated: October 1, 2024.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.

    Therefore, for the reasons stated in the preamble; EPA is proposing 
to amend 40 CFR chapter I as follows:

PART 372--TOXIC CHEMICAL RELEASE REPORTING: COMMUNITY RIGHT-TO-KNOW

0
1. The authority citation for part 372 continues to read as follows:

    Authority:  42 U.S.C. 11023 and 11048.

0
2. Amend Sec.  372.28 by:
0
a. In table 1 to paragraph (a)(1), revising the entry for ``Per- and 
polyfluoroalkyl substances''; and
0
b. In table 2 to paragraph (a)(2), adding, in alphabetical order, an 
entry for ``Per- and polyfluoroalkyl substances''.
    The revision and addition read as follows:


Sec.  372.28  Lower thresholds for chemicals of special concern.

    (a) * * *
    (1) * * *

[[Page 81810]]



                                           Table 1 to Paragraph (a)(1)
----------------------------------------------------------------------------------------------------------------
                                                                                                     Reporting
                        Chemical name                                       CAS No.                threshold (in
                                                                                                      pounds)
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
Per- and polyfluoroalkyl substances (Individually listed      see Sec.   372.65(d) and (e)......             100
 chemicals added by 15 U.S.C. 8921(b)(1) and (c)(1) and
 pursuant to 42 U.S.C. 11023(d)(2)). (EPA periodically
 updates the lists of covered chemicals at Sec.   372.65(d)
 and (e) to reflect chemicals that have been added by 15
 U.S.C. 8921).
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

    (2) * * *

                       Table 2 to Paragraph (a)(2)
------------------------------------------------------------------------
                                                             Reporting
                      Category name                        threshold (in
                                                              pounds)
------------------------------------------------------------------------
 
                              * * * * * * *
Per- and polyfluoroalkyl substances (Chemical categories             100
 added by 15 U.S.C. 8921 (b)(1) and (c)(1) and pursuant
 to 42 U.S.C. 11023(d)(2)). (EPA periodically updates
 the lists of covered chemicals at Sec.   372.65(f) to
 reflect chemical categories that have been added by 15
 U.S.C. 8921)...........................................
 
                              * * * * * * *
------------------------------------------------------------------------

0
3. Amend Sec.  372.65 by:
0
a. Revising the introductory text;
0
b. In table 4 to paragraph (d):
0
i. Removing the entries for ``Ammonium perfluorobutanoate''; ``Ammonium 
perfluorooctanoate''; ``Chromium(III) perfluorooctanoate''; 
``Ethanaminium, N,N,N-triethyl-, salt with 
1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-1-octanesulfonic acid 
(1:1)''; ``Hexafluoropropylene oxide dimer acid''; 
``Hexafluoropropylene oxide dimer acid ammonium salt''; ``1-
Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-, ammonium 
salt''; ``1-Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6-
tridecafluoro-, potassium salt''; ``1-Hexanesulfonic acid, 
1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-, compd. with 2,2'-
iminobis[ethanol] (1:1)''; ``Lithium (perfluorooctane)sulfonate''; ``1-
Octanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-
, ammonium salt''; ``Octanoyl fluoride, pentadecafluoro-''; 
``Perfluorobutane sulfonic acid''; ``Perfluorobutanesulfonate''; 
``Perfluorobutanoate''; ``Perfluorobutanoic acid''; ``Perfluorodecanoic 
acid''; ``Perfluorododecanoic acid''; ``Perfluorohexanesulfonic acid''; 
``Perfluorononanoic acid''; ``Perfluorooctane sulfonic acid''; and 
``Perfluorooctanoic acid''; ``Perfluorooctylsulfonyl fluoride''; 
``Potassium heptafluorobutanoate''; ``Potassium perfluorobutane 
sulfonate''; ``Potassium perfluorooctanesulfonate''; ``Potassium 
perfluorooctanoate''; ``Silver(I) perfluorooctanoate''; ``Sodium 
perfluorobutanoate''; and ``Sodium perfluorooctanoate'';
0
ii. Adding, in alphabetical order, entries for ``Broflanilide''; ``1-
Butanesulfonamide, 1,1,2,2,3,3,4,4,4-nonafluoro-N-(2-hydroxyethyl)-N-
methyl-''; ``1-Butanesulfonamide, 1,1,2,2,3,3,4,4,4-nonafluoro-N-
methyl-''; ``Cyclopentene, 1,3,3,4,4,5,5-heptafluoro-''; 
``Ethanesulfonamide, 1,1,2,2,2-pentafluoro-N-
[(pentafluoroethyl)sulfonyl]-, lithium salt''; ``6:2 Fluorotelomer 
alcohol''; ``Fulvestrant''; ``Hexaflumuron''; ``Pentane, 
1,1,1,2,2,3,4,5,5,5-decafluoro-3-methoxy-4-(trifluoromethyl)-''; 
``Perfluorotridecanoic acid''; ``Perfluoro(2-ethoxy-2-
fluoroethoxy)acetic acid ammonium salt''; ``2-Propenoic acid, 2-
[methyl[(nonafluorobutyl)sulfonyl]amino]ethyl ester''; 
``Pyrifluquinazon''; ``Tetraconazole''; 
``Triethoxy(3,3,4,4,5,5,6,6,7,7,8,8,8-tri-deca-fluorooctyl)silane''; 
and ``Trifluoro(trifluoromethyl) oxirane'';
0
c. In table 5 to paragraph (e):
0
i. Removing the entries for ``307-35-7''; ``307-55-1''; ``335-66-0''; 
``335-67-1''; ``335-76-2''; ``335-93-3''; ``335-95-5''; ``355-46-4''; 
``375-22-4''; ``375-73-5''; ``375-95-1''; ``1763-23-1''; ``2218-54-4''; 
``2395-00-8''; ``2795-39-3''; ``2966-54-3''; ``3825-26-1''; ``3871-99-
6''; ``10495-86-0''; ``13252-13-6''; ``29081-56-9''; ``29420-49-3''; 
``29457-72-5''; ``45048-62-2''; ``45187-15-3''; ``56773-42-3''; 
``62037-80-3''; ``68141-02-6''; ``68259-08-5''; and ``70225-16-0'';
0
ii. Adding, in numerical order, the entries for ``428-59-1''; ``647-42-
7''; ``1892-03-1''; ``34454-97-2''; ``51851-37-7''; ``67584-55-8''; 
``68298-12-4''; ``72629-94-8''; ``86479-06-3''; ``112281-77-3''; 
``129453-61-8''; ``132182-92-4''; ``132843-44-8''; ``337458-27-
2'';``908020-52-0''; and ``1207727-04-5''; and
0
d. Adding paragraph (f).
    The revisions and additions read as follows:


Sec.  372.65  Chemicals and chemical categories to which this part 
applies.

    The requirements of this part apply to the chemicals and chemical 
categories listed in this section. This section contains six listings. 
Paragraph (a) of this section is an alphabetical order listing of those 
chemicals that have an associated Chemical Abstracts Service (CAS) 
Registry number. Paragraph (b) of this section contains a CAS number 
order list of the same chemicals listed in paragraph (a) of this 
section. Paragraph (c) of this section contains the chemical categories 
for which reporting is required. These chemical categories are listed 
in alphabetical order and do not have CAS numbers. Paragraph (d) of 
this section is an alphabetical order listing of the per- and 
polyfluoroalkyl substances and their associated CAS Registry number. 
Paragraph (e) of this

[[Page 81811]]

section contains a CAS number order list of the same chemicals listed 
in paragraph (d) of this section. Each listing identifies the effective 
date for reporting under Sec.  372.30. Paragraph (f) of this section is 
an alphabetical order listing of the per- and polyfluoroalkyl 
substances chemical categories for which reporting is required. Per- 
and polyfluoroalkyl substances automatically added to the list of 
chemicals for which reporting is required pursuant to the Fiscal Year 
2020 National Defense Authorization Act, section 7321(c), shall be 
incorporated as chemical categories to include the acid and associated 
salts, acyl/sulfonyl halides, and anhydride of that acid if added 
pursuant to a published final toxicity value that provides toxicity 
values for an acid and associated salts and/or acyl/sulfonyl halides 
and/or anhydride.
* * * * *
    (d) * * *

                        Table 4 to Paragraph (d)
------------------------------------------------------------------------
           Chemical name                 CAS No.         Effective date
------------------------------------------------------------------------
 
                              * * * * * * *
Broflanilide......................       1207727-04-5           1/1/2025
 
                              * * * * * * *
1-Butanesulfonamide,                       34454-97-2           1/1/2025
 1,1,2,2,3,3,4,4,4-nonafluoro-N-(2-
 hydroxyethyl)-N-methyl-..........
 
                              * * * * * * *
1-Butanesulfonamide,                       68298-12-4           1/1/2025
 1,1,2,2,3,3,4,4,4-nonafluoro-N-
 methyl-..........................
 
                              * * * * * * *
Cyclopentene, 1,3,3,4,4,5,5-                1892-03-1           1/1/2025
 heptafluoro-.....................
 
                              * * * * * * *
Ethanesulfonamide, 1,1,2,2,2-             132843-44-8           1/1/2025
 pentafluoro-N-
 [(pentafluoroethyl)sulfonyl]-,
 lithium salt.....................
 
                              * * * * * * *
6:2 Fluorotelomer alcohol.........           647-42-7           1/1/2025
 
                              * * * * * * *
Fulvestrant.......................        129453-61-8           1/1/2025
 
                              * * * * * * *
Hexaflumuron......................         86479-06-3           1/1/2025
 
                              * * * * * * *
Pentane, 1,1,1,2,2,3,4,5,5,5-             132182-92-4           1/1/2025
 decafluoro-3-methoxy-4-
 (trifluoromethyl)-...............
 
                              * * * * * * *
Perfluorotridecanoic acid.........         72629-94-8           1/1/2025
 
                              * * * * * * *
Perfluoro(2-ethoxy-2-                     908020-52-0           1/1/2025
 fluoroethoxy)acetic acid ammonium
 salt.............................
 
                              * * * * * * *
2-Propenoic acid, 2-                       67584-55-8           1/1/2025
 [methyl[(nonafluorobutyl)sulfonyl
 ]amino]ethyl ester...............
 
                              * * * * * * *
Pyrifluquinazon...................        337458-27-2           1/1/2025
 
                              * * * * * * *
Tetraconazole.....................        112281-77-3           1/1/2025
 
                              * * * * * * *
Triethoxy(3,3,4,4,5,5,6,6,7,7,8,8,         51851-37-7           1/1/2025
 8-tri-deca-fluorooctyl)silane....
 
                              * * * * * * *
Trifluoro(trifluoromethyl) oxirane           428-59-1           1/1/2025
 
                              * * * * * * *
------------------------------------------------------------------------

    (e) * * *

[[Page 81812]]



                                            Table 5 to Paragraph (e)
----------------------------------------------------------------------------------------------------------------
                   CAS No.                                      Chemical name                    Effective date
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
428-59-1.....................................  Trifluoro(trifluoromethyl) oxirane............           1/1/2025
 
                                                  * * * * * * *
647-42-7.....................................  6:2 Fluorotelomer alcohol.....................           1/1/2025
 
                                                  * * * * * * *
1892-03-1....................................  Cyclopentene, 1,3,3,4,4,5,5-heptafluoro-......           1/1/2025
 
                                                  * * * * * * *
34454-97-2...................................  1-Butanesulfonamide, 1,1,2,2,3,3,4,4,4-                  1/1/2025
                                                nonafluoro-N-(2-hydroxyethyl)-N-methyl-.
 
                                                  * * * * * * *
51851-37-7...................................  Triethoxy(3,3,4,4,5,5,6,6,7,7,8,8,8-trideca-             1/1/2025
                                                fluorooctyl)silane.
 
                                                  * * * * * * *
67584-55-8...................................  2-Propenoic acid, 2-                                     1/1/2025
                                                [methyl[(nonafluorobutyl)sulfonyl]amino]ethyl
                                                ester.
 
                                                  * * * * * * *
68298-12-4...................................  1-Butanesulfonamide, 1,1,2,2,3,3,4,4,4-                  1/1/2025
                                                nonafluoro-N-methyl-.
 
                                                  * * * * * * *
72629-94-8...................................  Perfluorotridecanoic acid.....................           1/1/2025
 
                                                  * * * * * * *
86479-06-3...................................  Hexaflumuron..................................           1/1/2025
 
                                                  * * * * * * *
112281-77-3..................................  Tetraconazole.................................           1/1/2025
 
                                                  * * * * * * *
129453-61-8..................................  Fulvestrant...................................           1/1/2025
 
                                                  * * * * * * *
132182-92-4..................................  Pentane, 1,1,1,2,2,3,4,5,5,5-decafluoro-3-               1/1/2025
                                                methoxy-4-(trifluoromethyl)-.
 
                                                  * * * * * * *
132843-44-8..................................  Ethanesulfonamide, 1,1,2,2,2-pentafluoro-N-              1/1/2025
                                                [(pentafluoroethyl)sulfonyl]-, lithium salt.
 
                                                  * * * * * * *
337458-27-2..................................  Pyrifluquinazon...............................           1/1/2025
 
                                                  * * * * * * *
908020-52-0..................................  Perfluoro(2-ethoxy-2-fluoroethoxy)acetic acid            1/1/2025
                                                ammonium salt.
 
                                                  * * * * * * *
1207727-04-5.................................  Broflanilide..................................           1/1/2025
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

    (f) Per- and polyfluoroalkyl chemical category listing.

                        Table 6 to Paragraph (f)
------------------------------------------------------------------------
                    Category name                        Effective date
------------------------------------------------------------------------
9-chlorohexadecafluoro-3-oxanone-1-sulfonic acid (9Cl-          1/1/2025
 PF3ONS) (CASRN 756426-58-1), salts, sulfonyl
 halides, and anhydride (includes all associated
 salts and sulfonyl halides, including the
 following):.........................................
    73606-19-6: potassium 9-chlorohexadecafluoro-3-
     oxanonane-1 sulfonate
11-chloroeicosafluoro-3-oxaundecane-1-sulfonic acid             1/1/2025
 (11Cl-PF3OUdS) (CASRN 763051-92-9), salts, sulfonyl
 halides, and anhydride (includes all associated
 salts and sulfonyl halides, including the
 following):.........................................
    83329-89-9: potassium 11-chloroeicosafluoro-3-
     oxaundecane-1-sulfonate
Hexafluoropropylene oxide dimer acid (HFPO-DA, GenX)            1/1/2025
 (CASRN 13252-13-6), salts, and acyl halides
 (includes all associated salts and acyl halides,
 including the following):...........................
    2062-98-8: propanoyl fluoride, 2,3,3,3-
     tetrafluoro-2 (heptafluoropropoxy)-]
    62037-80-3: ammonium perfluoro-2-methyl-3-
     oxahexanoate
    67118-55-2: potassium 2,3,3,3-tetrafluoro-2-
     (heptafluoropropoxy)propanoate

[[Page 81813]]

 
    67963-75-1: sodium 2,3,3,3-tetrafluoro-
     2(heptafluoropropoxy)propanoate
Perfluorobutanesulfonic acid (PFBS), salts, sulfonyl            1/1/2025
 halides, and anhydride (CASRN 375-73-5) (includes
 all associated salts and sulfonyl halides, including
 the following):.....................................
    375-72-4: perfluorobutanesulfonyl fluoride
    29420-49-3: potassium perfluorobutane sulfonate
    36913-91-4: perfluorobutanesulfonic anhydride
    60453-92-1: sodium nonafluorobutane-1-sulfonate
    68259-10-9: ammonium perfluorobutanesulfonate
    70225-18-2: bis(2-hydroxyethyl)ammonium
     perfluorobutanesulfonate
    131651-65-5: lithium nonafluorobutane-1-sulfonate
    220689-12-3: tetrabutylphosphonium
     perfluorobutanesulfonate
    507453-86-3: magnesium nonafluorobutanesulfonate
Perfluorobutanoic acid (PFBA) (CASRN 375-22-4),                 1/1/2025
 salts, acyl halides, and anhydride (includes all
 associated salts and acyl halides, including the
 following):.........................................
    335-42-2: perfluorobutanoyl fluoride
    336-59-4: perfluorobutanoic anhydride
    375-16-6: heptafluorobutyryl chloride
    2218-54-4: sodium perfluorobutanoate
    2966-54-3: potassium perfluorobutanoate
    3794-64-7: silver heptafluorobutyrate
    10495-86-0: ammonium perfluorobutanoate
    73755-28-9: rhodium(II) perfluorobutyrate dimer
Perfluorodecanoic acid (PFDA) (CASRN 335-76-2),                 1/1/2025
 salts, acyl halides, and anhydride (includes all
 associated salts and acyl halides, including the
 following):.........................................
    307-38-0: perfluorodecanoyl chloride
    3108-42-7: ammonium Perfluorodecanoate
    3830-45-3: sodium Perfluorodecanoate
    942199-24-8: perfluorodecanoic anhydride
Perfluorododecanoic acid (PFDoA) (CASRN 307-55-1),              1/1/2025
 salts, acyl halides, and anhydride (includes all
 associated salts and acyl halides, including the
 following):.........................................
    3793-74-6: ammonium tricosafluorododecanoate
    1456735-80-0: perfluorododecanoic anhydride
Perfluorohexanesulfonic acid (PFHxS) (CASRN 355-46-             1/1/2025
 4), salts, sulfonyl halides, and anhydride (includes
 all associated salts and sulfonyl halides, including
 the following):.....................................
    423-50-7: perfluorohexanesulfonyl fluoride
    3871-99-6: potassium perfluorohexanesulfonate
    55120-77-9: lithium perfluorohexanesulfonate
    68259-08-5: ammonium perfluorohexanesulfonate
    70225-16-0: bis(2-hydroxyethyl)ammonium
     perfluorohexanesulfonate
    82382-12-5: sodium perfluorohexanesulfonate
    109065-55-6: perfluorohexanesulfonic anhydride
Perfluorohexanoic acid (PFHxA) (CASRN 307-24-4),                1/1/2025
 salts, acyl halides, and anhydride (includes all
 associated salts and acyl halides, including the
 following):.........................................
    308-13-4: perfluorohexanoic anhydride
    336-02-7: silver perfluorohexanoate
    355-38-4: perfluorohexanoyl fluoride
    335-53-5: perfluorohexanoyl chloride
    2923-26-4: sodium perfluorohexanoate
    3109-94-2: potassium undecafluorohexanoate
    21615-47-4: ammonium perfluorohexanoate
Perfluorononanoic acid (PFNA) (CASRN 375-95-1),                 1/1/2025
 salts, acyl halides, and anhydride (includes all
 associated salts and acyl halides, including the
 following):.........................................
    558-95-2: heptadecafluorononanoyl fluoride
    4149-60-4: ammonium perfluorononanoate
    21049-38-7: potassium perfluorononanoate
    21049-39-8: sodium heptadecafluorononanoate
    52447-23-1: heptadecafluorononanoyl chloride
    228407-54-3: perfluorononanoic anhydride
1H,1H, 2H, 2H-Perfluorooctane sulfonic acid (6:2 FTS)           1/1/2025
 (CASRN 27619-97-2), salts, sulfonyl halides, and
 anhydride (includes all associated salts and
 sulfonyl halides, including the following):.........
    2043-57-4: 1H,1H,2H,2H-Perfluorooctyl iodide
    27619-89-2: 3,3,4,4,5,5,6,6,7,7,8,8,8-
     tridecafluorooctanesulphonyl chloride
    27619-94-9: sodium 3,3,4,4,5,5,6,6,7,7,8,8,8-
     tridecafluorooctane-1-sulfonate
    59587-38-1: potassium 3,3,4,4,5,5,6,6,7,7,8,8,8-
     tridecafluorooctanesulfonate
    59587-39-2: 6:2 fluorotelomer sulfonate ammonium
    1807944-82-6: 1-octanesulfonic acid,
     3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluoro-, barium
     salt (2:1)
Perfluorooctanoic acid (PFOA) (CASRN 335-67-1),                 1/1/2025
 salts, acyl halides, and anhydride (includes all
 associated salts and acyl halides, including the
 following):.........................................
    335-64-8: pentadecafluorooctanoyl chloride
    335-66-0: pentadecafluorooctanoyl fluoride
    335-93-3: silver perfluorooctanoate
    335-95-5: sodium perfluorooctanoate

[[Page 81814]]

 
    2395-00-8: potassium perfluorooctanoate
    3825-26-1: ammonium perfluorooctanoate
    17125-58-5: lithium perfluorooctanoate
    17125-60-9: cesium perfluorooctanoate
    33496-48-9: perfluorooctanoic anhydride
    68141-02-6: chromium perfluorooctanoate
    98065-31-7: potassium pentadecafluorooctanoate--
     water (1:1:2)
Perfluorooctanesulfonic acid (PFOS) (CASRN 1763-23-             1/1/2025
 1), salts, sulfonyl halides, and anhydride (includes
 all associated salts and sulfonyl halides, including
 the following):.....................................
    307-35-7: perfluorooctylsulfonyl fluoride
    423-92-7: perfluorooctanesulfonic anhydride
    2795-39-3: potassium perfluorooctanesulfonate
    4021-47-0: sodium perfluorooctanesulfonate
    29081-56-9: ammonium perfluorooctanesulfonate
    29457-72-5: lithium perfluorooctanesulfonate
    56773-42-3: tetraethylammonium
     perfluorooctanesulfonate
    70225-14-8: 1-octanesulfonic
     acid,1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
     heptadecafluoro-, compd with 2,2'-
     iminobis[ethanol] (1:1)
    91036-71-4: magnesium
     bis(heptadecafluorooctanesulfonate)
    111873-33-7: tetrabutylammonium
     perfluorooctanesulfonate
Perfluoropropanoic acid (PFPrA) (CASRN 422-64-0),               1/1/2025
 salts, acyl halides, and anhydride (includes all
 associated salts and acyl halides, including the
 following):.........................................
    356-42-3: pentafluoropropanoic anhydride
    378-76-7: potassium perfluoropropanoate
    378-77-8: sodium perfluoropropanoate
    422-59-3: perfluoropropanoyl chloride
    422-61-7: perfluoropropanoyl fluoride
Perfluoroundecanoic acid (PFUnA) (CASRN 2058-94-8),             1/1/2025
 salts, acyl halides, and anhydride (includes all
 associated salts and acyl halides, including the
 following):.........................................
    4234-23-5: ammonium perfluoroundecanoate
    30377-53-8: potassium perfluoroundecanoate
    60871-96-7: sodium perfluoroundecanoate
    97163-17-2: calcium perfluoroundecanoate
    942199-03-3: perfluoroundecanoic anhydride
------------------------------------------------------------------------

[FR Doc. 2024-22966 Filed 10-7-24; 8:45 am]
BILLING CODE 6560-50-P


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