81776 Federal Register / Vol. 89, No. 195 / Tuesday, October 8, 2024 / Proposed Rules 

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. 

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: dean.rachel@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. Executive Summary 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you manufacture, 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-inventorytri-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-toKnow 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 Perand 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 carbonVerDate Sep<11>2014 21:20 Oct 07, 2024 Jkt 265001 PO 00000 Frm 00003 Fmt 4701 Sfmt 4702 E:\FR\FM\08OCP2.SGM 08OCP2

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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 webbased 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, a- 

(2-methyl-1-oxo-2-propenyl)-whydroxypoly(oxy-1,2-ethanediyl), a-(2- 

methyl-1-oxo-2-propenyl)-w-[(2-methyl1-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 


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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 wellestablished standard operating 

procedures with a strict screening 

pipeline and process to only include 

applicable data from several wellrecognized 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-workspacecollaborative-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 doseresponse 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 Perand 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 


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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 


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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-3Hperfluorononanoate (CASRN 958445– 

44–8), sodium 4,8-dioxa-3Hperfluorononanoate (NOCAS 892452; 

CASRN 2250081–67–3), potassium 

2,2,3-trifluoro-3-[1,1,2,2,3,3-hexafluoro3- 

(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 


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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-chlorohexadecafluoro3-oxanone-1-sulfonic acid (9ClPF3ONS) (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-oxanone1-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 (11ClPf3OUdS) (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 


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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 9ClPF3ONS 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 9ClPF3ONS. 

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 b-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 9ClPF3ONS 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 

mg/l exposures. In another study by the 

same authors, the reported whole body 

kinetic BCF was 3,612 at the nominal 10 

mg/l exposure and 3,615 at the nominal 

100 mg/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 9ClPF3ONS, 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 (11ClPF3OUdS) (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 

∼1.2mM which was obtained from the 

linear dose-response curve for 11clPF3OUdS. 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 

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PF3OUdS was observed after 105 days 

(Ref. 22). 

Available data suggest that 11clPF3OUdS 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 11clPF3OUdS, 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 nonafluorobutane1-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 

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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 PFBAindependent 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 PFBAinduced 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, dosedependent, 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 (PPARa) 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 × 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 


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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/kgday (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 wellconducted 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 × 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/kgday. 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/kgday, 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). 


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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 shortterm 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 × 10¥10 mg/kg-day based on 

immune effects (decreased serum antitetanus 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 × 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 metaanalysis suggest that decreases in birth 

weight are an adverse effect of PFNA 

exposure in humans (Ref. 34). In animal 


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studies, offspring of PFNA-exposed 

rodents had reduced bodyweights and 

survival, and delayed development (Ref. 

4). ATSDR established an intermediateduration oral minimal risk level (MRL) 

of 3 × 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 × 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 (TNFa, Ilb, 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 × 10¥8 mg/kg bw-day, based on 

the following co-critical effects: 

decreased anti-tetanus and antidiphtheria 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 


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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 TRIlisted 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 × 10¥7 mg/kg bwday, 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/kgd. 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 × 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/kgday) rats. Serum enzymes indicative of 

hepatocellular (e.g., ALT) and biliary 

epithelial (e.g., ALP) injury were also 


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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 mg a.i./L, with a steep dose 

response (35%, 95% and 100% 

mortality at 0.0202, 0.0284, and 0.0428 

mg 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 mg a.i./L 

was based upon 6–8% reductions in 

length, total offspring, birth rate, and 

time to first brood at 11.6 mg a.i./L. The 

mysid study did not establish a 

definitive NOAEC endpoint because at 

the lowest test concentration, 0.0018 mg 

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 


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LC50s of 9.99, 13.5, and 14 mg ai/kg dry 

sediment. In a 28-day spiked sediment 

test with Leptocheirus plumulosus, the 

NOAEC was determined to be 3.8 mg 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 mg a.i./bee and acute oral LD50

= 0.0149 mg 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)-Nmethyl-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/kgday 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 


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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]estra1,3,5(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 mg 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/m3 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/m3). 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). 


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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 blackspotted 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/kgday, 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 


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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, gglutamyltransferase, 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-ofentry effects (squamous cell metaplasia 

of laryngeal mucosa and mononuclear 

cell infiltration) and systemic effects 

(follicular cell hypertrophy of thyroid). 

The inhalation no-observed-adverseeffect concentration (NOAEC) is 

established at 0.159 mg/L and lowestobserved-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./kgbw/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 mg 

a.i./L) and the estuarine/marine 

Sheepshead Minnow (Cyprinodon 

variegatus; LC50>3,400 mg 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 mg 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 mg a.i./L. 

A chronic early life stage toxicity test 

with the estuarine/marine C. variegatus 

resulted in a NOAEC of 120 mg 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 mg ai/L (Ref. 63). 

Tetraconazole is moderately toxic to 

the freshwater invertebrate waterflea 


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(Daphnia magna; EC50=2,360 mg a.i./L) 

and highly toxic to the estuarine/marine 

invertebrate mysid shrimp 

(Americamysis bahia; LC50=440 mg a.i./ 

L) on an acute exposure basis. A chronic 

toxicity study of the D. magna resulted 

in a NOAEC = 190 mg a.i./L above which 

there was a 20.9% reduction in 

reproduction in comparison to the 

control at a LOAEC of 209 mg a.i./L. A 

chronic toxicity study with A. bahia 

resulted in a NOAEC of 87 mg 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 mg 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 halflives greater than the experimental 

period tested (t1⁄2∼ 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/kgday. 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 mediumdose group were similar to controls 

(therefore the NOAEL = 100 mg/kg-day). 

Due to the high mortality of the highdose 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/m3 (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/ 

m3)- and high (TWA 3,660 mg/m3)- 

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/m3 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). 


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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 (PFDANa, 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 


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(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. 


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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 TRIreportable 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 highend 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 perfirm 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; 


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• 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 nonalkali 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 


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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 


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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 (pIUR)). 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 naturallyoccurring estrogen or other endocrinedisruption 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 


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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.merriamwebster.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 


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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. 


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9. EPA seeks comment on its 

approach using ECOTOX and EPA 

HAWC projects (and information 

summarized by other EPA databases in 

general) for the purpose of supporting 

chemical listings on TRI (see fulvestrant 

(CASRN: 129453–61–8) and (1H,1H, 2H, 

2H-perfluorooctane sulfonic acid (6:2 

FTS) (CASRN 27619–97–2)). EPA also 

solicits comment on whether other 

methods of providing evidence to 

support TRI chemical listings other than 

listing support documents specifically 

drafted for the TRI action may be 

appropriate, such as read-across 

methods (i.e., applying hazard data from 

a data-rich source chemical to a related 

data-poor chemical to determine 

potential properties or hazards). 

10. EPA seeks comment on the 100- 

pound reporting threshold being 

proposed for the listing in this 

rulemaking. Additionally, EPA seeks 

comment on whether the threshold used 

for these proposed additions to the TRI 

list should be aligned with the threshold 

applicable to PFAS added pursuant to 

NDAA section 7321(b) and (c). 

11. EPA seeks comment on its 

proposed regulatory framework for 

establishing PFAS categories 

encompassing the salts and acyl/ 

sulfonyl halides of future PFAS acids 

that will be automatically added to the 

TRI list after a triggering event pursuant 

to NDAA section 7321(c). 

12. EPA requests comment on what 

nomenclature to use for these categories 

(e.g., ‘‘[acid name], salts and acyl/ 

sulfonyl halides’’, ‘‘[acid name], salts, 

acyl/sulfonyl halides, and the anhydride 

form’’, ‘‘[acid name] and associated 

compounds’’, or some other 

convention). For the ‘‘associated 

compounds’’ nomenclature, EPA would 

define or interpret ‘‘associated 

compounds’’ to refer to salts, acyl/ 

sulfonyl halides, and/or anhydrides. 

In addition to the requests for 

comment described in this document, 

EPA also requests comment on the 

additional topics identified in this 

document to help inform potential 

future TRI regulatory activities. 

13. Since PFAS are ubiquitous in the 

environment and robust hazard data 

exist for well-studied PFAS (Ref. 3, 14, 

70), EPA is considering additional 

avenues to expedite adding PFAS to the 

TRI list. For example, the OECD has 

described a standardized terminology 

for defining PFAS and grouping them 

based on their structural traits (Ref. 7). 

EPA has developed Markush 

representations to group and categorize 

PFAS based on generalized structures 

(see https://comptox.epa.gov/ 

dashboard/chemical-lists/ 

PFASMARKUSH). EPA has also 

developed PFAS-specific structural 

representations known as ToxPrints to 

characterize PFAS by their atom, bond, 

chain, and functional group to facilitate 

category development (Ref. 76). More 

broadly, OECD has published technical 

guidance for the development, 

justification and application of category 

and analogue approaches. These 

analogue and category approaches are 

typically underpinned by one or more of 

the following similarity contexts 

including structural, physicochemical, 

metabolic, bioactivity, reactivity and 

(eco)toxicological similarity. While no 

single categorization approach will 

satisfy all needs and the specifics of a 

given category approach will likely 

differ depending on the intended 

application, such grouping approaches 

are well-established in the scientific 

literature and are widely applied within 

the scientific and regulatory community 

(Ref. 7). These approaches typically 

categorize PFAS based on foundational 

understandings of chemistry and 

toxicity. To this end, EPA is requesting 

comment on whether the Agency should 

identify PFAS for which there is a lack 

of direct evidence to support a TRI 

listing, but instead base the listing on 

similarities (e.g., structural similarities) 

a particular PFAS shares with other 

PFAS for which there is sufficient 

evidence, and apply such evidence to 

the data-poor PFAS. For example, EPA 

is proposing to add 6:2 fluorotelomer 

alcohol, 6:2 fluorotelomer sulfonamide 

betaine, 6:2 fluorotelomer sulfonate 

ammonium, and 8:2 fluorotelomer 

sulfonic acid to the TRI list based on 

available data. It is also aware of other 

similar chemical substances such as 3:1 

fluorotelomer alcohol, and 4:2 

fluorotelomer alcohol. While EPA may 

not have hazard data specific on these 

chemicals, it could determine that these 

listings are appropriate based on 

generally accepted scientific principles. 

In this example, data on the chemicals 

being proposed for listing could be used 

as sufficient evidence to demonstrate 

that these other, similar chemicals (i.e., 

3:1 fluorotelomer alcohol and 4:2 

fluorotelomer alcohol) also meet the 

criteria for listing on the TRI. EPA posits 

that X:2 and X:1 fluorotelomer alcohols 

and their precursors and derivatives, 

which are expected to break down into 

the corresponding X-length fluoroalkyl 

carboxylates, are expected to result in 

similar adverse effects on human health 

and the environment as substances 

already TRI-listed as well as those being 

proposed for addition to the TRI. EPA 

is considering the appropriateness of 

this general approach, as well as means 

to further speciate its application, for 

these as well as other categories as 

described by OECD and other regulatory 

bodies, including EPA. EPA is soliciting 

comment on this approach, as well as 

requesting assistance in identifying 

additional chemicals to consider based 

on such an approach. 

14. Pursuant to the NDAA, for PFAS 

added to the TRI list pursuant to NDAA 

section 7321(b) and (c), EPA must, 

within five years after the NDAA’s 

enactment, determine whether it is 

warranted to revise the 100-pound 

reporting threshold provided by the 

NDAA for chemicals added to the TRI 

pursuant to those paragraphs. 

Accordingly, EPA seeks comment on its 

proposal to implement a 100-pound 

reporting threshold for PFAS added to 

the TRI list pursuant to NDAA section 

7321(b) and (c). Similarly, EPA seeks 

comment on the 100-pound reporting 

threshold being proposed for the listing 

in this rulemaking. Further, EPA is 

soliciting comment on whether the 

reporting threshold should be consistent 

across all PFAS on the TRI list, 

regardless of the specific mechanism 

that caused their addition to the TRI list. 

15. EPA seeks comment on whether 

documents related to EPA actions other 

than those specified in Unit VII. should 

be identified as events that the Agency 

interprets as ‘‘finaliz[ing] a toxicity 

value’’ as that term is used in NDAA 

section 7321(c)(1)(A)(1). 

16. The Agency is soliciting comment 

on the listing support documents 

specifically prepared for this action and 

whether they justify its proposed 

determination that there is sufficient 

evidence to establish that one or more 

of the criteria for listing under EPCRA 

section 313(d)(2) have been met. 

IX. References 

The following is a listing of the 

documents that are specifically 

referenced in this document. The docket 

includes these documents and other 

information considered by EPA, 

including documents that are referenced 

within the documents that are included 

in the docket, even if the referenced 

document is not itself physically located 

in the docket. For assistance in locating 

these other documents, please consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

1. U.S. Environmental Protection Agency 

(September 2024). Economic Analysis for 

the Addition of Certain Per- and 

Polyfluoroalkyl Substances; Community 

Right-to-Know Toxic Chemical Release 

Reporting; Proposed Rule (RIN 2070– 

AL03). 

2. U.S. Environmental Protection Agency 

(2023). TSCA Section 8(a)(7) Reporting 

and Recordkeeping Requirements for 


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Perfluoroalkyl and Polyfluoroalkyl 

Substances; Final Rule. 88 FR 70516 

(October 11, 2023 (FRL–7902–02– 

OCSPP)). https://www.govinfo.gov/ 

content/pkg/FR-2023-10-11/pdf/2023- 

22094.pdf 

3. U.S. Environmental Protection Agency. 

Our current understanding of the human 

health and environmental risks of PFAS. 

2022. https://www.epa.gov/pfas/ourcurrent-understanding-human-healthand-environmental-risks-pfas 

4. Agency for Toxic Substances and Disease 

Registry (2021). Toxicological Profile for 

Perfluoroalkyls. U.S. Department of 

Health and Human Services. https://

www.atsdr.cdc.gov/toxprofiles/tp200.pdf 

5. Agency for Toxic Substances and Disease 

Registry. Per- and Polyfluoroalkyl 

Substances (PFAS) and Your Health. 

PFAS in the U.S. Population. June 2023. 

https://www.atsdr.cdc.gov/pfas/healtheffects/us-population.html 

6. Centers for Disease Control and Prevention 

(2015). Fourth National Report on 

Human Exposure to Environmental 

Chemicals. Department of Health and 

Human Services. https://www.cdc.gov/ 

biomonitoring/pdf/fourthreport_

updatedtables_feb2015.pdf 

7. Organisation for Economic Co-Operation 

and Development (2021). Reconciling 

Terminology of the Universe of Per- and 

Polyfluoroalkyl Substances: 

Recommendations and Practical 

Guidance. Series on Risk Management. 

No.61. Environment Directorate 

Chemicals and Biotechnology 

Committee. https://one.oecd.org/ 

document/ENV/CBC/MONO(2021)25/en/ 

pdf 

8. Buck, R.C., et al. (2021). Identification and 

Classification of Commercially Relevant 

Per- and Poly Fluoroalkyl Substances 

(PFAS). Integrated Environmental 

Assessment and Management 17(5):p. 

1045–1055. https://doi.org/10.1002/ 

ieam.4450 

9. U.S. Environmental Protection Agency. 

CompTox Chemicals Dashboard. 2021. 

https://comptox.epa.gov/dashboard/ 

10. U.S. Environmental Protection Agency. 

EPA PFAS chemicals without explicit 

structures. CompTox Chemicals 

Dashboard. August 2021. https://

comptox.epa.gov/dashboard/chemicallists/PFASDEV1 

11. U.S. Environmental Protection Agency 

(1994). Addition of Certain Chemicals; 

Toxic Chemical Release Reporting; 

Community Right-to-Know; Final Rule. 

59 FR 61432 (November 30, 1994 (FRL– 

4922–2)). 

12. U.S. Environmental Protection Agency. 

ECOTOX Knowledgebase. September 

2023. https://cfpub.epa.gov/ecotox/ 

13. U.S. Environmental Protection Agency. 

EPA Health Assessment Workspace 

Collaborative (EPA HAWC): ORD SEM 

PFAS 150. 2022. https://hawc.epa.gov/ 

assessment/100500085/ 

14. Carlson, L.M., et al. (2022). Systematic 

Evidence Map for Over One Hundred 

and Fifty Per- and Polyfluoroalkyl 

Substances (PFAS). Environmental 

Health Perspectives 130(5):p. 056001. 

https://doi.org/10.1289/EHP10343 

15. Olker, J.H., et al. (2022). The 

ECOTOXicology Knowledgebase: A 

Curated Database of Ecologically 

Relevant Toxicity Tests to Support 

Environmental Research and Risk 

Assessment. Environmental Toxicology 

and Chemistry 41(6):p. 1520–1539. 

https://doi.org/10.1002/etc.5324 

16. U.S. Environmental Protection Agency 

(2022). Addition of Certain Chemicals; 

Community Right-to-Know Toxic 

Chemical Release Reporting. 87 FR 

73475 (November 30, 2022 (FRL–5927– 

02–OCSPP)). 

17. U.S. Environmental Protection Agency 

(2023). TRI Listing Analysis for 

Perfluoroheptanesulfonic acid (PFHpS) 

(CASRN 375–92–8). 

18. Interstate Technology Regulatory Council 

(2023). Chemistry, Terminology, and 

Acronyms: Introduction to the PFAS 

Family. https://pfas-1.itrcweb.org/2-2- 

chemistry-terminology-and-acronyms/ 

#2_2_2 

19. U.S. Environmental Protection Agency. 

PFAS Environmental Reaction Library 

Version 1.1: Hydrolysis Schemes. July 

2022. https://qed.epa.gov/static_qed/cts_

app/docs/PFAS%20HTML/ 

PFASEnvironmentalReactionLibrary_

ver1-1.htm#EnvLib_Scheme_6 

20. U.S. Environmental Protection Agency 

(2023). Human Health Hazard TRI 

Listing Support Document for 9- 

Chlorohexadecafluoro-3-oxanone-1- 

sulfonic acid (9Cl-PF3ONS) (CASRN 

756426–58–1). 

21. U.S. Environmental Protection Agency 

(2023). Ecological Hazard TRI Listing 

Support Document for 9- 

Chlorohexadecafluoro-3-oxanone-1- 

sulfonic acid (9Cl-PF3ONS) (CASRN 

756426–58–1). 

22. U.S. Environmental Protection Agency 

(2023). Ecological Hazard TRI Listing 

Support Document for 11- 

Chloroeicosafluoro-3-oxaundecane-1- 

sulfonic acid (11Cl-PF3OUdS) (CASRN 

763051–92–9). 

23. U.S. Environmental Protection Agency 

(2021). Human Health Toxicity Values 

for Hexafluoropropylene Oxide (HFPO) 

Dimer Acid and Its Ammonium Salt 

(CASRN 13252–13–6 and CASRN 

62037–80–3). Office of Water. https://

www.epa.gov/system/files/documents/ 

2021-10/genx-chemicals-toxicityassessment_tech-edited_oct-21-508.pdf 

24. U.S. Environmental Protection Agency 

(2021). Human Health Toxicity Values 

for Perfluorobutane Sulfonic Acid 

(CASRN 375–73–5) and Related 

Compound Potassium Perfluorobutane 

Sulfonate (CASRN 29420–49–3). Office 

of Research and Development, Center for 

Public Health and Environmental 

Assessment. https://cfpub.epa.gov/ncea/ 

risk/recordisplay.cfm?deid=350888 

25. U.S. Environmental Protection Agency 

(2022). IRIS Toxicological Review of 

Perfluorobutanoic Acid (PFBA, CASRN 

375- 22–4) and Related Salts. Office of 

Research and Development, Center for 

Public Health and Environmental 

Assessment. EPA/600/R–20/345F. 

https://iris.epa.gov/ChemicalLanding/ 

&substance_nmbr=701 

26. U.S. Environmental Protection Agency 

(2024). IRIS Toxicological Review of 

Perfluorodecanoic Acid (PFDA) and 

Related Salts. Office of Research and 

Development, Center for Public Health 

and Environmental Assessment. https:// 

ordspub.epa.gov/ords/eims/ 

eimscomm.getfile?p_download_

id=549465 

27. World Health Organization & 

International Programme on Chemical 

Safety (2012). Guidance for 

immunotoxicity risk assessment for 

chemicals. https://iris.who.int/handle/ 

10665/330098 

28. National Toxicology Program (NTP) 

(2016). NTP Monograph: Immunotoxicity 

associated with exposure to 

perfluorooctanoic acid (PFOA) or 

perfluorooctane sulfonate (PFOS). 

Research Triangle Park, NC: U.S. 

Department of Health and Human 

Services, Office of Health Assessment 

and Translation. https://ntp.niehs.

nih.gov/ntp/ohat/pfoa_pfos/pfoa_

pfosmonograph_508.pdf 

29. U.S. Environmental Protection Agency 

(2022). Review of EPA’s analyses to 

support EPA’s national primary drinking 

water rulemaking for PFAS (EPA–SAB– 

22–008). https://sab.epa.gov/ords/sab/ 

f?p=100:18:16490947993:::18:P18_

ID:2601 

30. U.S. Environmental Protection Agency 

(2023). Human Health Hazard TRI 

Listing Support Document for 

Perfluorododecanoic acid (PFDoA) 

(CASRN 307–55–1). 

31. U.S. Environmental Protection Agency 

(2023). IRIS Toxicological Review of 

Perfluorohexanesulfonic Acid (PFHxS) 

and Related Salts (Public Comment and 

External Review Draft). Office of 

Research and Development, Center for 

Public Health and Environmental 

Assessment. https://iris.epa.gov/ 

ChemicalLanding/&substance_nmbr=705 

32. U.S. Environmental Protection Agency 

(2023). IRIS Toxicological Review of 

Perfluorohexanoic Acid [PFHxA, CASRN 

307–24–4] and Related Salts. Office of 

Research and Development, Center for 

Public Health and Environmental 

Assessment. https://iris.epa.gov/ 

ChemicalLanding/&substance_nmbr=704 

33. U.S. Environmental Protection Agency 

(2023). PFAS National Primary Drinking 

Water Regulation; Final Rule. 89 FR 

32532 (April 26, 2024 (FRL 8543–02– 

OW)). https://www.regulations.gov/ 

document/EPA-HQ-OW-2022-0114-0027 

34. Wright, J., et al. (2023). Systematic review 

and meta-analysis of birth weight and 

PFNA exposures. Environmental 

Research 222(115357). https://doi.org/ 

10.1016/j.envres.2023.115357. Epub 

2023 Jan 24. PMID: 36706898. 

35. U.S. Environmental Protection Agency 

(2024). IRIS Toxicological Review of 

Perfluorononanoic Acid (PFNA) and 

Related Salts (CASRN 375–95–1) 

(External Review Draft). Office of 

Research and Development, Center for 

Public Health and Environmental 

Assessment. EPA/635/R–24/031a. 

https://ordspub.epa.gov/ords/eims/ 


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36. Radke, E.G., et al. (2022). Epidemiology 

Evidence for Health Effects of 150 perand Polyfluoroalkyl Substances: A 

Systematic Evidence Map. 

Environmental Health Perspectives 

130(9). https://doi.org/10.1289/ 

EHP11185 

37. Sheng, N., et al. (2016). Comparative 

hepatotoxicity of 6:2 fluorotelomer 

carboxylic acid and 6:2 fluorotelomer 

sulfonic acid, two fluorinated 

alternatives to long-chain perfluoroalkyl 

acids, on adult male mice. Archives of 

Toxicology 91(8):p. 2909–2919. https://

doi.org/10.1007/s00204-016-1917-2 

38. U.S. Environmental Protection Agency 

(2024). Final: Human Health Toxicity 

Assessment for Perfluorooctanoic Acid 

(PFOA) and Related Salts. Office of 

Water. EPA Document No. 815R240068. 

https://www.epa.gov/system/files/ 

documents/2024-05/final-human-healthtoxicity-assessment-pfoa.pdf 

39. U.S. Environmental Protection Agency 

(2005). Guidelines for Carcinogen Risk 

Assessment. Risk Assessment Forum. 

Washington, DC. https://www.epa.gov/ 

sites/default/files/2013-09/documents/ 

cancer_guidelines_final_3-25-05.pdf 

40. U.S. Environmental Protection Agency 

(2024). Final: Human Health Toxicity 

Assessment for Perfluorooctane Sulfonic 

Acid (PFOS) and Related Salts. Office of 

Water. EPA Document No. 815R24007. 

https://www.epa.gov/system/files/ 

documents/2024-04/main_final-toxicityassessment-for-pfos_2024-04-09-refsformatted_508c.pdf 

41. U.S. Environmental Protection Agency 

(2023). ORD Human Health Toxicity 

Value for Perfluoropropanoic Acid 

(CASRN 422–64–0 DTXSID8059970). 

Office of Research and Development, 

Center for Public Health and 

Environmental Assessment. EPA/600/R– 

22–042F. https://assessments.epa.gov/ 

risk/document/&deid=358291 

42. U.S. Environmental Protection Agency 

(2023). Human Health Hazaard TRI 

Listing Support Document for 

Perfluoroundecanoic acid (PFUnA) 

(CASRN 2058–94–8). 

43. Takahashi, M., et al. (2014). Repeated 

dose and reproductive/developmental 

toxicity of perfluoroundecanoic acid in 

rats. The Journal of Toxicological 

Sciences 39(1):p. 97–108. https://doi.org/ 

10.2131/jts.39.97 

44. U.S. Environmental Protection Agency 

(2020). Broflanilide: New Active 

Ingredient Human Health Risk 

Assessment (final). Office of Chemical 

Safety and Pollution Prevention, Office 

of Pesticide Programs, Health Effects 

Division. https://www.regulations.gov/ 

document/EPA-HQ-OPP-2018-0053-0012 

45. U.S. Environmental Protection Agency 

(2020). Broflanilide: Ecological Risk 

Assessment for the Proposed Section 3 

New Chemical Registration. Office of 

Chemical Safety and Pollution 

Prevention, Office of Pesticide Programs, 

Environmental Fate and Effects Division. 

https://www.regulations.gov/document/ 

EPA-HQ-OPP-2018-0053-0011 

46. U.S. Environmental Protection Agency 

(2023). Human Health Hazard TRI 

Listing Support Document for 1- 

Butanesulfonamide, 1,1,2,2,3,3,4,4,4- 

nonafluoro-N-(2-hydroxyethyl)-Nmethyl- (MeFBSE) (CASRN 34454–97–2). 

47. U.S. Environmental Protection Agency 

(2023). Human Health Hazard TRI 

Listing Support Document for 1- 

Butanesulfonamide, 1,1,2,2,3,3,4,4,4- 

nonafluoro-N-methyl- (MeFBSA) 

(CASRN 68298–12–4). 

48. U.S. Environmental Protection Agency 

(2023). Ecological Hazard TRI Listing 

Support Document for Cyclopentene, 

1,3,3,4,4,5,5-heptafluoro (HFCPE; 

CASRN 1892–03–1). 

49. U.S. Environmental Protection Agency 

(2023). Human Health Hazard TRI 

Listing Support Document for Lithium 

bis[(pentafluoroethyl)sulfonyl]azanide 

(CASRN 132843–44–8). 

50. U.S. Environmental Protection Agency 

(2023). Human Health Hazard TRI 

Listing Support Document for 6:2 

Fluorotelomer alcohol (6:2 FTOH) 

(CASRN 647–42–7). 

51. U.S. Environmental Protection Agency. 

ECOTOX query results for fulvestrant 

(CASRN 129453–61–8). [Accessed 

August 16, 2023]. 

52. Clubbs, R.L. and B.W. Brooks (2007). 

Daphnia magna responses to a vertebrate 

estrogen receptor agonist and an 

antagonist: A multigenerational study. 

Ecotoxicology and Environmental Safety 

67(3):p. 385–398. https://doi.org/ 

10.1016/j.ecoenv.2007.01.009 

53. Roepke, T.A., M.J. Snyder, and G.N. Cherr 

(2005). Estradiol and endocrine 

disrupting compounds adversely affect 

development of sea urchin embryos at 

environmentally relevant concentrations. 

Aquatic Toxicology 71(2):p. 155–173. 

https://doi.org/10.1016/j.aquatox.

2004.11.003 

54. Loomis, A.K. and P. Thomas (2000). 

Effects of Estrogens and Xenoestrogens 

on Androgen Production by Atlantic 

Croaker Testes In Vitro: Evidence for a 

Nongenomic Action Mediated by an 

Estrogen Membrane Receptor. Biology of 

Reproduction 62(4):p. 995–1004. https:// 

doi.org/10.1095/biolreprod62.4.995 

55. U.S. Environmental Protection Agency 

(2014). Registration Review: Preliminary 

Ecological Risk Assessment and 

Endangered Species Effects 

Determination for Hexaflumuron. Office 

of Pesticide Programs, Environmental 

Fate and Effects Division. https://

www.regulations.gov/document/EPAHQ-OPP-2009-0568-0018 

56. U.S. Environmental Protection Agency 

(2023). Human Health Hazard TRI 

Listing Support Document for Pentane, 

1,1,1,2,2,3,4,5,5,5-decafluoro-3-methoxy4-(trifluoromethyl)- (CASRN 132182–92– 

4). 

57. U.S. Environmental Protection Agency 

(2023). Ecological Hazard TRI Listing 

Support Document for 

Perfluorotridecanoic acid (PFTrDA) 

(CASRN 72629–94–8). 

58. Rice, P.A., et al. (2021). Comparative 

analysis of the physicochemical, 

toxicokinetic, and toxicological 

properties of ether-PFAS. Toxicology 

and Applied Pharmacology 422:p. 

115531. https://doi.org/10.1016/

j.taap.2021.115531 

59. U.S. Environmental Protection Agency 

(2023). Human Health Hazard TRI 

Listing Support Document for 

Perfluoro(2-ethoxy-2-fluoroethoxy)acetic 

acid ammonium salt (EEA–NH4) 

(CASRN 908020–52–0). 

60. U.S. Environmental Protection Agency 

(2023). Human Health Hazard TRI 

Listing Support Document for 2- 

Propenoic acid, 2-[methyl[

(nonafluorobutyl)sulfonyl]amino]ethyl 

ester (MeFBSEA) (CASRN 67584–55–8). 

61. U.S. Environmental Protection Agency 

(2018). Pyrifluquinazon: Human Health 

Risk Assessment for the Proposed Use on 

Tuberous and Corm Vegetables, Leafy 

Vegetables (including greenhouse-grown 

lettuce), Brassica Head and Stem 

Vegetables, Fruiting Vegetables 

(including greenhouse-grown pepper and 

tomato), Cucurbit Vegetables (including 

greenhouse-grown cucumber), Citrus 

Fruits, Pome Fruits, Stone Fruits, Small 

Vine Climbing Fruit (excluding fuzzy 

kiwifruit), Tree Nuts, Leaf Petiole 

Vegetables, and Cotton, and for the 

Establishment of a Tolerance without a 

U.S. Registration for Residues in/on 

Imported Tea. Office of Pesticide 

Programs, Health Effects Division. 

https://www.regulations.gov/document/

EPA-HQ-OPP-2011-0971-0023 

62. U.S. Environmental Protection Agency 

(2020). Tetraconazole: Draft Human 

Health Risk Assessment in Support of 

Registration Review. Office of Pesticide 

Programs, Health Effects Division 

https://www.regulations.gov/document/ 

EPA-HQ-OPP-2015-0061-0011 

63. U.S. Environmental Protection Agency 

(2020). Tetraconazole: Draft Ecological 

Risk Assessment for Registration Review. 

Office of Pesticide Programs, 

Environmental Fate and Effects Division. 

https://www.regulations.gov/document/ 

EPA-HQ-OPP-2015-0061-0014 

64. U.S. Environmental Protection Agency 

(2023). Human Health Hazard TRI 

Listing Support Document for 

Triethoxy(3,3,4,4,5,5,6,6,7,7,8,8,8-

tridecafluorooctyl)silane (CAS 51851– 

37–7). 

65. U.S. Environmental Protection Agency 

(2023). Human Health Hazard TRI 

Listing Support Document for Trifluoro

(trifluoromethyl) oxirane (HFPO) 

(CASRN 428–59–1). 

66. U.S. Environmental Protection Agency 

(2023). TSCA Section 4(a)(1) Test Order 

for Trifluoro(trifluoromethyl)oxirane. 

https://www.epa.gov/system/files/ 

documents/2023-01/10434-01_TSCA_

Test%20Order_PFAS-HFPO%29_AA_

Signature_2023-01-04.pdf 

67. U.S. Environmental Protection Agency 

(1999). 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; Final Rule. 64 FR 


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58666 (October 29, 1999 (FRL–6389– 

11)). https://www.govinfo.gov/content/ 

pkg/FR-1999-10-29/pdf/99-28169.pdf 

68. U.S. Environmental Protection Agency 

(2023). Changes to Reporting 

Requirements for Per- and 

Polyfluoroalkyl Substances and to 

Supplier Notifications for Chemicals of 

Special Concern; Community Right-toKnow Toxic Chemical Release Reporting; 

Final Rule. 88 FR 74360 (October 31, 

2023 (FRL–8742–04–OCSPP)). https://

www.govinfo.gov/content/pkg/FR-2023- 

10-31/pdf/2023-23413.pdf 

69. U.S. Environmental Protection Agency. 

PFAS explained. 2022. https://

www.epa.gov/pfas/pfas-explained 

70. Kotthoff, M., et al. (2015). Perfluoroalkyl 

and polyfluoroalkyl substances in 

consumer products. Environmental 

Science and Pollution Research. 

Environmental Science and Pollution 

Research 22(19):p. 14546–14559. https:// 

doi.org/10.1007/s11356-015-4202-7 

71. U.S. Environmental Protection Agency 

(1994). Alternate Threshold for Facilities 

with Low Annual Reportable Amounts; 

Toxic Chemical Release Reporting; 

Community Right-To-Know; Final Rule. 

59 FR 61488 (November 30, 1994 (FRL– 

4920–5)). https://archives.federalregister.

gov/issue_slice/1994/11/30/61429- 

61502.pdf 

72. California Department of Toxic 

Substances Control. DTSC Toxicity 

Criteria Rule for Human Health Risk 

Assessments, Responses to Frequently 

Asked Questions (FAQs). 2024. https://

dtsc.ca.gov/toxicity-criteria-rule-forhuman-health-risk-assessments-faq/ 

73. U.S. Environmental Protection Agency 

(2013). Tier 3 Toxicity Value White 

Paper. Regional Tier 3 Toxicity Value 

Workgroup. OSWER Human Health 

Regional Risk Assessors Forum. https:// 

nepis.epa.gov/Exe/ZyPDF.cgi/

P100NTU6.PDF?Dockey=P100NTU6.PDF 

74. U.S. Environmental Protection Agency 

(2018). Human Health Toxicity Values 

for Hexafluoropropylene Oxide (HFPO) 

Dimer Acid and Its Ammonium Salt 

(CASRN 13252–13–6 and CASRN 

62037–80–3), Also Known as ‘‘GenX 

Chemicals’’ (Public Comment Draft). 

Office of Water. EPA–823–P–18–001. 

https://www.epa.gov/sites/default/files/ 

2018-11/documents/genx_public_

comment_draft_toxicity_assessment_

nov2018-508.pdf 

75. U.S. Environmental Protection Agency 

(2016). Health Effects Support Document 

for Perfluorooctane Sulfonate (PFOS). 

Office of Water. EPA 822–R–16–002. 

https://www.epa.gov/sites/default/files/ 

2016-05/documents/pfos_hesd_final_

508.pdf 

76. Richard, A.M., et al. (2023). A New 

CSRML Structure-Based Fingerprint 

Method for Profiling and Categorizing 

Per- and Polyfluoroalkyl Substances 

(PFAS). Chemical Research in 

Toxicology 36(3):p. 508–534. https://

doi.org/10.1021/acs.chemrestox.2c00403 

77. U.S. Environmental Protection Agency 

(2024). Rule-Related ICR; Addition of 

Certain Per- and Polyfluoroalkyl 

Substances; Toxic Chemical Release; 

Proposed Rule (RIN 2070–AL03). EPA 

ICR No. 2796.01, OMB Control No. 

2070–NEW. 

X. What are the Statutory and 

Executive Orders reviews associated 

with this action? 

Additional information about these 

statutes and Executive Orders can be 

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


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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 

■ 1. The authority citation for part 372 

continues to read as follows: 

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

■ 2. Amend § 372.28 by: 

■ a. In table 1 to paragraph (a)(1), 

revising the entry for ‘‘Per- and 

polyfluoroalkyl substances’’; and 

■ 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: 

§ 372.28 Lower thresholds for chemicals 

of special concern. 

(a) * * * 

(1) * * * 


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TABLE 1 TO PARAGRAPH (a)(1) 

Chemical name CAS No. 

Reporting 

threshold 

(in pounds) 

*******

Per- and polyfluoroalkyl substances (Individually listed 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 § 372.65(d) and (e) to reflect chemicals that have been added by 15 U.S.C. 8921).

see § 372.65(d) and (e). 100 

* * * * * * * 

(2) * * * 

TABLE 2 TO PARAGRAPH (a)(2) 

Category name 

Reporting 

threshold 

(in pounds) 

*******

Per- and polyfluoroalkyl substances (Chemical categories 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 § 372.65(f) to reflect chemical categories that have 

been added by 15 U.S.C. 8921) ...................................................................................................................................................... 100 

* * * * * * * 

■ 3. Amend § 372.65 by: 

■ a. Revising the introductory text; 

■ b. In table 4 to paragraph (d): 

■ 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’’; 

■ ii. Adding, in alphabetical order, 

entries for ‘‘Broflanilide’’; ‘‘1-Butane

sulfonamide, 1,1,2,2,3,3,4,4,4- 

nonafluoro-N-(2-hydroxyethyl)-Nmethyl-’’; ‘‘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-decafluoro3-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’’; 

■ c. In table 5 to paragraph (e): 

■ 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’’; 

■ 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 

■ d. Adding paragraph (f). 

The revisions and additions read as 

follows: 

§ 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 


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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 § 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, 1,1,2,2,3,3,4,4,4-nonafluoro-N-(2-hydroxyethyl)-N-methyl- ..................................... 34454–97–2 1/1/2025 

* * * * * * * 

1-Butanesulfonamide, 1,1,2,2,3,3,4,4,4-nonafluoro-N-methyl- .................................................................... 68298–12–4 1/1/2025 

* * * * * * * 

Cyclopentene, 1,3,3,4,4,5,5-heptafluoro- ..................................................................................................... 1892–03–1 1/1/2025 

* * * * * * * 

Ethanesulfonamide, 1,1,2,2,2-pentafluoro-N-[(pentafluoroethyl)sulfonyl]-, lithium salt ............................... 132843–44–8 1/1/2025 

* * * * * * * 

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-decafluoro-3-methoxy-4-(trifluoromethyl)- ...................................................... 132182–92–4 1/1/2025 

* * * * * * * 

Perfluorotridecanoic acid ............................................................................................................................. 72629–94–8 1/1/2025 

* * * * * * * 

Perfluoro(2-ethoxy-2-fluoroethoxy)acetic acid ammonium salt ................................................................... 908020–52–0 1/1/2025 

* * * * * * * 

2-Propenoic acid, 2-[methyl[(nonafluorobutyl)sulfonyl]amino]ethyl ester .................................................... 67584–55–8 1/1/2025 

* * * * * * * 

Pyrifluquinazon ............................................................................................................................................. 337458–27–2 1/1/2025 

* * * * * * * 

Tetraconazole .............................................................................................................................................. 112281–77–3 1/1/2025 

* * * * * * * 

Triethoxy(3,3,4,4,5,5,6,6,7,7,8,8,8-tri-deca-fluorooctyl)silane ...................................................................... 51851–37–7 1/1/2025 

* * * * * * * 

Trifluoro(trifluoromethyl) oxirane .................................................................................................................. 428–59–1 1/1/2025 

* * * * * * * 

(e) * * * 


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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-nonafluoro-N-(2-hydroxyethyl)-N-methyl- ................. 1/1/2025 

* * * * * * * 

51851–37–7 ............................ Triethoxy(3,3,4,4,5,5,6,6,7,7,8,8,8-trideca-fluorooctyl)silane ................................................... 1/1/2025 

*******

67584–55–8 ............................ 2-Propenoic acid, 2-[methyl[(nonafluorobutyl)sulfonyl]amino]ethyl ester ................................ 1/1/2025 

*******

68298–12–4 ............................ 1-Butanesulfonamide, 1,1,2,2,3,3,4,4,4-nonafluoro-N-methyl- ................................................ 1/1/2025 

*******

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-methoxy-4-(trifluoromethyl)- .................................. 1/1/2025 

*******

132843–44–8 .......................... Ethanesulfonamide, 1,1,2,2,2-pentafluoro-N-[(pentafluoroethyl)sulfonyl]-, lithium salt ........... 1/1/2025 

*******

337458–27–2 .......................... Pyrifluquinazon ......................................................................................................................... 1/1/2025 

*******

908020–52–0 .......................... Perfluoro(2-ethoxy-2-fluoroethoxy)acetic acid ammonium salt ................................................ 1/1/2025 

*******

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-PF3ONS) (CASRN 756426–58–1), salts, sulfonyl halides, and anhydride (includes all associated salts and sulfonyl halides, including the following): ................................................................... 1/1/2025 

73606–19–6: potassium 9-chlorohexadecafluoro-3-oxanonane-1 sulfonate 

11-chloroeicosafluoro-3-oxaundecane-1-sulfonic acid (11Cl-PF3OUdS) (CASRN 763051–92–9), salts, sulfonyl halides, and 

anhydride (includes all associated salts and sulfonyl halides, including the following): ........................................................... 1/1/2025 

83329–89–9: potassium 11-chloroeicosafluoro-3-oxaundecane-1-sulfonate 

Hexafluoropropylene oxide dimer acid (HFPO-DA, GenX) (CASRN 13252–13–6), salts, and acyl halides (includes all associated salts and acyl halides, including the following): ................................................................................................................ 1/1/2025 

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 


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TABLE 6 TO PARAGRAPH (f)—Continued 

Category name Effective date 

67963–75–1: sodium 2,3,3,3-tetrafluoro-2(heptafluoropropoxy)propanoate 

Perfluorobutanesulfonic acid (PFBS), salts, sulfonyl halides, and anhydride (CASRN 375–73–5) (includes all associated 

salts and sulfonyl halides, including the following): ................................................................................................................... 1/1/2025 

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), salts, acyl halides, and anhydride (includes all associated salts and acyl 

halides, including the following): ................................................................................................................................................ 1/1/2025 

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), salts, acyl halides, and anhydride (includes all associated salts and 

acyl halides, including the following): ........................................................................................................................................ 1/1/2025 

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), salts, acyl halides, and anhydride (includes all associated salts and 

acyl halides, including the following): ........................................................................................................................................ 1/1/2025 

3793–74–6: ammonium tricosafluorododecanoate 

1456735–80–0: perfluorododecanoic anhydride 

Perfluorohexanesulfonic acid (PFHxS) (CASRN 355–46–4), salts, sulfonyl halides, and anhydride (includes all associated 

salts and sulfonyl halides, including the following): ................................................................................................................... 1/1/2025 

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), salts, acyl halides, and anhydride (includes all associated salts and 

acyl halides, including the following): ........................................................................................................................................ 1/1/2025 

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), salts, acyl halides, and anhydride (includes all associated salts and 

acyl halides, including the following): ........................................................................................................................................ 1/1/2025 

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) (CASRN 27619–97–2), salts, sulfonyl halides, and anhydride (includes all associated salts and sulfonyl halides, including the following): ................................................................................ 1/1/2025 

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), salts, acyl halides, and anhydride (includes all associated salts and acyl 

halides, including the following): ................................................................................................................................................ 1/1/2025 

335–64–8: pentadecafluorooctanoyl chloride 

335–66–0: pentadecafluorooctanoyl fluoride 

335–93–3: silver perfluorooctanoate 

335–95–5: sodium perfluorooctanoate 


ddrumheller on DSK120RN23PROD with PROPOSALS2
81814 Federal Register / Vol. 89, No. 195 / Tuesday, October 8, 2024 / Proposed Rules 

TABLE 6 TO PARAGRAPH (f)—Continued 

Category name Effective date 

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), salts, sulfonyl halides, and anhydride (includes all associated 

salts and sulfonyl halides, including the following): ................................................................................................................... 1/1/2025 

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), salts, acyl halides, and anhydride (includes all associated salts and 

acyl halides, including the following): ........................................................................................................................................ 1/1/2025 

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), salts, acyl halides, and anhydride (includes all associated salts 

and acyl halides, including the following): ................................................................................................................................. 1/1/2025 

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 


ddrumheller on DSK120RN23PROD with PROPOSALS2