[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:
[email protected].
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Does this action apply to me?
You may be potentially affected by this action if you manufacture,
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:
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.
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).
Federal facilities.
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
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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:
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.
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.
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
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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:
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.
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.
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.
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:
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.
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.
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.
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.
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.
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).
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).
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.).
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.
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.
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):
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);
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);
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);
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);
Perfluorobutanoic acid (PFBA) (CASRN 375-22-4)*, Salts,
Acyl Halides, and Anhydride Category, which is based on 313(d)(2)(B)
(Chronic Human Health);
Perfluorodecanoic acid (PFDA) (CASRN 335-76-2)*, Salts,
Acyl Halides, and Anhydride Category, which is based on 313(d)(2)(B)
(Chronic Human Health);
Perfluorododecanoic acid (PFDoA) (CASRN 307-55-1)*, Salts,
Acyl Halides, and Anhydride Category, which is based on 313(d)(2)(B)
(Chronic Human Health);
Perfluorohexanesulfonic acid (PFHxS) (CASRN 355-46-4)*,
Salts, Sulfonyl Halides, and Anhydride Category; which is based on
313(d)(2)(B) (Chronic Human Health);
Perfluorohexanoic acid (PFHxA) (CASRN 307-24-4)*, Salts,
Acyl Halides, and Anhydride Category, which is based on 313(d)(2)(B)
(Chronic Human Health);
Perfluorononanoic acid (PFNA) (CASRN 375-95-1)*, Salts,
Acyl Halides, and Anhydride Category, which is based on 313(d)(2)(B)
(Chronic Human Health);
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);
Perfluorooctanoic acid (PFOA) (CASRN 335-67-1)*, Salts,
Acyl Halides, and Anhydride Category, which is based on 313(d)(2)(B)
(Chronic Human Health);
Perfluorooctanesulfonic acid (PFOS) (CASRN 1763-23-1)*,
Salts, Sulfonyl Halides, and Anhydride Category; which is based on
313(d)(2)(B) (Chronic Human Health);
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
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 [LC50
<=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 LC50 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-\5\ mg/kg bw-day and a chronic
RfD of 3x10-\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 10-3 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 10-9 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 10-10 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 10-4 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
10-6 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 10-9
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)-1 based on renal cell
carcinomas in human males. The Agency also developed a draft chronic
RfD of 3 x 10-8 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)-1 based on hepatocellular adenomas and
carcinomas in female rats (Ref. 40). The Agency also developed a
chronic RfD of 1.0 x 10-7 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
10-4 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:
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);
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);
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);
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);
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);
6:2 Fluorotelomer alcohol (6:2 FTOH) (CASRN 647-42-7),
which is based on EPCRA 313(d)(2)(B) (Chronic Human Health);
Fulvestrant (CASRN 129453-61-8), which is based on EPCRA
313(d)(2)(C) (Effect on the Environment);
Hexaflumuron (CASRN 86479-06-3), which is based on EPCRA
313(d)(2)(C) (Effect on the Environment);
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);
Perfluorotridecanoic acid (PFTrDA) (CASRN 72629-94-8),
which is based on EPCRA 313(d)(2)(C) (Effect on the Environment);
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);
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);
Pyrifluquinazon (CASRN 337458-27-2), which is based on
EPCRA 313(d)(2)(B) (Chronic Human Health);
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);
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
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, Q1* (mg/kg/day)-1, of broflanilide based
upon male rat testicular Leydig cell tumor rates is 2.48 x
10-3 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 LC50 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]]
LC50s 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 LD50 = 0.0088 [micro]g a.i./bee and acute oral
LD50 = 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 LC50 in
Oryzias latipes), 0.26 mg/L in aquatic invertebrates (48-hour
EC50 for immobilization of Daphnia magna), and 0.9 mg/L in
algae (72-hour EC50 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
LC50) 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 (EC50 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 EC50) (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
LC50 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 EC50 of 8.2 mg/L for immobility in D.
magna, PFTrDA can cause adverse aquatic effects. The MATC of 0.03 mg/L
and EC50 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; EC50=2,360 [micro]g a.i./L) and highly toxic
to the estuarine/marine invertebrate mysid shrimp (Americamysis bahia;
LC50=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:
Hexafluoropropylene oxide dimer acid (HFPO-DA, GenX)
(CASRN 13252-13-6);
Hexafluoropropylene oxide dimer acid ammonium salt (CASRN
62037-80-3):
Perfluorobutanesulfonic acid (PFBS), Salts, Sulfonyl
Halides, and Anhydride Category;
Perfluorobutanesulfonate (CASRN 45187-15-3);
Perfluorobutanesulfonic acid (PFBS) (CASRN 375-73-5);
Potassium perfluorobutane sulfonate (CASRN 29420-49-3);
Perfluorobutanoic acid (PFBA), Salts, Acyl Halides, and
Anhydride Category;
Ammonium perfluorobutanoate (CASRN 10495-86-0);
Perfluorobutanoate (CASRN 45048-62-2);
Perfluorobutanoic acid (PFBA) (CASRN 375-22-4);
Potassium heptafluorobutanoate (CASRN 2966-54-3);
Sodium perfluorobutanoate (CASRN 2218-54-4);
Perfluorodecanoic acid (PFDA), Salts, Acyl Halides, and
Anhydride Category:
Perfluorodecanoic acid (PFDA) (CASRN 335-76-2);
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).
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:
Perfluorododecanoic acid (PFDoA) (CASRN 307-55-1);
Perfluorohexanesulfonic acid (PFHxS), Salts, and Sulfonyl Halides,
and Anhydride Category:
Perfluorohexanesulfonic acid (PFHxS) (CASRN 355-46-4);
1-Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6-
tridecafluoro-, ammonium salt (CASRN 68259-08-5)
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)
1-Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6-
tridecafluoro-, potassium salt (CASRN 3871-99-6)
Perfluorononanoic acid (PFNA), Salts, Acyl Halides, and
Anhydride Category:
Perfluorononanoic acid (PFNA) (CASRN 375-95-1);
Perfluorooctanesulfonic acid (PFOS), Salts, Sulfonyl Halides, and
Anhydride Category:
Lithium (perfluorooctane)sulfonate (CASRN 29457-72-5);
Potassium perfluorooctanesulfonate (CASRN 2795-39-3);
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);
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);
Perfluorooctylsulfonyl fluoride (CASRN 307-35-7);
Perfluorooctanesulfonic acid (PFOS) (CASRN 1763-23-1);
Perfluorooctanoic acid (PFOA), Salts, Acyl Halides, and
Anhydride Category:
Perfluorooctanoic acid (PFOA) (CASRN 335-67-1);
Silver(I) perfluorooctanoate (CASRN 335-93-3);
Sodium perfluorooctanoate (CASRN 335-95-5);
Potassium perfluorooctanoate (CASRN 2395-00-8);
Ammonium perfluorooctanoate (CASRN 3825-26-1);
Chromium(III) perfluorooctanoate (CAS RN 68141-02-6); and
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:
Final Toxicity Value. The date on which the Administrator
finalizes a toxicity value for the PFAS or class of PFAS;
Significant New Use Rule (SNUR). The date on which the
Administrator makes a covered determination for the PFAS or class of
PFAS;
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]]
Addition as an Active Chemical Substance. The date on
which the PFAS or class of PFAS to which a covered determination
applies is:
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
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):
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).
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).
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).
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).
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).
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).
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
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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
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6. Centers for Disease Control and Prevention (2015). Fourth
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9. U.S. Environmental Protection Agency. CompTox Chemicals
Dashboard. 2021. https://comptox.epa.gov/dashboard/
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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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13. U.S. Environmental Protection Agency. EPA Health Assessment
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Chemicals; Community Right-to-Know Toxic Chemical Release Reporting.
87 FR 73475 (November 30, 2022 (FRL-5927-02-OCSPP)).
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22. U.S. Environmental Protection Agency (2023). Ecological Hazard
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26. U.S. Environmental Protection Agency (2024). IRIS Toxicological
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29. U.S. Environmental Protection Agency (2022). Review of EPA's
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33. U.S. Environmental Protection Agency (2023). PFAS National
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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